AMWA Advocacy

Advocacy History & Timeline

May 1, 2007—AMWA participated in Women’s Health Month

May 7, 2007—- endorsed Rep Michael Michaud’s bill, HR 2064, the Compassionate care for Servicewomen Act, to ensure that emergency contraception is stocked at each military health-care facility.

May 8, 2007—-endorsed the Clinical Laboratory Improvement Amendments modification act, HR 1237, to suspend and revise the current regulation that subjects pathologist and others who screen for cervical cancer to annual proficiency testing.

May 29, 2007—-signed on with ACLU, NARAL, National Abortion Federation, National Family Planning and Reproductive Health Ass., National Women’s Law Center, Planned Parenthood, Reproductive Health Technologies Project to oppose the Prescription Drug User Fee Amendment of 2007, S.1082, which includes mifepristone. It has been used safely since 1988 when it was first licensed in France and should not be held to a different standard than other drugs. Letter was sent to Senator E. Kennedy.

May 30, 2007—-AMWA supported HR 4055 introduced by Rep. Rosa DeLauro to require Medicare coverage of HPV testing as part of cervical screening.

May 31, 2007— individual AMWA members in conjunction with PNHP signed on online to promote Michael Moore’s film, Sicko, which will be premiering June 29, 2007 bringing the case for single payer health insurance to the theaters of America.

June 11, 2007—-sent an email to Adam Zimmerman at Pro-Choice America to oppose the Senate considering the nomination of Richard Honaker to the US District Court in Wyoming because his views on reproductive rights and religion will adversely affect the reproductive rights women have gained.

June 11, 2007—spoke to Carmen R. Green, MD a Robert Wood Johnson Health Policy Fellow in Senator Christopher Dodd’s office to endorse S.174, Children’s Compassionate Care Act. It addresses palliative care for children including grants for training pediatric fellows.

June 13, 2007—Kimberly Sneed and Dr. Omega Silva attended the National Care Conference at the Ronald Reagan Building in DC, the theme of which was the Voice of One, the Power of Many. The conference covered three major issues:
Make bold investments to fight global poverty.
Empower women and girls to protect themselves and to fight HIV/AIDS.
Provide universal access to basic education.

Senator Chuck Hagel and Representative Nita Lowey spoke at the evening plenary.

AMWA is a partner with Care and had coauthored a coffee table book on women around the world
June 18, 2007—letter sent to Senator Max Baucus encouraging him to include a provision in the State children’s Health Insurance Program, reauthorization that gives the option to cover legal immigrant children and pregnant women under Medicaid and the SCHIP.

June 27, 2007—signed on to a letter generated by The National Abortion Federation to endorse the Stop Deceptive Advertising for Women’s Services Act (HR 2478).

July 1, 2007—signed on to the American Legacy Foundation’s letter to R. J. Reynolds to ask the company to withdraw its new brand targeted for women and advertised as Camel No. 9.

July 17, 2007—AMWA sent letters to the House, Reps. Dingell and Rangel, on the SCHIP legislation (similar to the June 18th letter to Senator Baucus).

July 17, 2007—joined the Cytology Proficiency Improvement Coalition in a letter to ask members of the House to cosponsor the Improvement Act (H.R. 1237).

July 30, 2007—Dr. Omega Silva represented AMWA at a meeting of the NIH Peer Review Working Group. This group met with the Director of NIH, Dr. Elias Zerhouni, and the Co-chairs, Dr. Keith Yamamoto and Dr. Lawrence Tabak, to discuss the grant review process in an effort to offer suggestions to make the process less cumbersome and time consuming. This meeting in Washington, DC of the scientific society representatives is one of a series around the country.

August 13, 2007—Drs. Claudia Morrissey and Omega Silva attended the meeting of the National Women’s Health Agenda Taskforce to discuss the creation of a plan for universal access to healthcare. The group sought a definition of health and decided to use the WHO definition. The group agreed on a general description of quality healthcare which is to be ratified by the groups represented.

August 15, 2007—signed on to the American Legacy Foundation’s letter to R. J. Reynolds to withdraw advertising for Camel No.9 cigarettes which targets women and girls.

August 26, 2007—Dr. Susan L. Ivey wrote to Rep Lois Capps (Ca-23) to thank her for leading a group of 40 members of Congress to take action by sending letters to the editors of 11 women’s magazines urging them to stop running ads for Camel No. 9 and all tobacco products.

August 28, 2007—Dr. Ivey sent a letter to her congressperson on behalf of Moms Rising to support the reauthorization of the State Children’s Health Insurance Program.
September 1, 2007—AMWA helped sponsor the Gynecologic Cancer Awareness activities with a coalition of organizations. AMWA signed on to the Sudan Divestment and Accountability Act requesting divestment from Darfur.

September 17, 2007—Dr. Omega Silva attended the Partners Meeting for the Vulvodynia Awareness Campaign of the Office Research on Women’s Health, NIH and signed on AMWA as a partner. A press launch will be held at the Press Club in DC on October 24 at 10 am.

September 24, 2007—Dr. Omega Silva attended the Policy Discussion of the American Public Health Association on Nov. 4, 2007 at the Renaissance Hotel 3:00-6:00 pm to discuss AMWA’s Aid in Dying position paper. The APHA was considering a similar position paper. Kathryn Tucker, JD is the author of the paper.

September 25, 2007— Dr. Omega Silva attended the American Legacy Foundation Luncheon in DC on November 26, 2007 to discuss ways to continue advocating for tobacco control and cessation issues.

September 26, 2007—AMWA released its new 2007 version of Aid in Dying position paper. It is available on the website at www.amwa-doc.org.

September 26, 2007—The Advocacy Committee agreed to allow the Sanarus Medical to present its new product for cryoablation of fibroadenomas of the breast at the annual meeting in Anaheim.

October 1, 2007—Sent a letter to President Bush asking him not to veto the SCHIP appropriation which passed the House and Senate.

October 24, 2007—Dr. Omega Silva attended the Launch Press Conference of the Vulvodynia Awareness Campaign of the Office of Women’s Health at NIH. AMWA is a partner along with several other organizations in that campaign. It was held at the National Press Club in Washington, DC.

January 13, —The FDA is taking action on compounded menopausal hormonal drug preparations in no small part due to the advocacy of AMWA members. The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called “bio-identical hormone replacement therapy,” or “BHRT” products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that
unfounded claims like these mislead women and health care professionals.

January 13, 2008—Susan Ivey wrote a letter to the Oregonian protesting the use of the term suicide to describe aid in dying.

January 17, 2008—President –Elect (Claudia Morrisey) and the Past President (Susan Ivey) signed on to the Citizens’ Petition to President Bush to provide support to the UN peacekeeping force in Darfur through our partner, Save Darfur Coalition.

January 18, 2008—AWMA signed onto the Amicus Brief of the National Advocates for Pregnant Women in the case of Amber Lovill who in the process of drug recovery became pregnant was serving a criminal sentence under a term of community service was ordered to serve time in jail and prison to protect her unborn child after the state of Texas learned of her pregnancy. This brief was filed in conjunction with the ACLU.

January 29, 2008—Dr. Omega Silva and Dr. Eliza Taylor attended the Hollywood on the Hill premiere of the showing of a film depicting cervical cancer survivors and how advancements in screening and prevention made a difference. It was sponsored by the National Council of Women’s Organizations Health Task force at the American Federation of Teachers building.

January 30, 2008—AMWA signed onto the second letter opposing the nomination of Richard Honaker to the U. S. District Court of Appeals because of his anti-choice stand and his application of his religious views to the interpretation of the law. See June 11, 2007. His hearing is set to occur on February 12, 2008 in the Senate.

January 30, 2008— Drs. Galindo and Ivey sent a letter to the Director, Regulations and Rulings Division of the Alcohol and Tobacco Tax and Trade Bureau on its proposed labeling and advertising of wines, distilled spirits and malt beverages. They suggested labeling similar to serving facts on most foods.

January 30, 2008—Dr. Omega Silva reviewed the revised Educational Tool Kit on Beverage Alcohol Consumption of The Distilled Spirits Council. AMWA endorsed the previous version and its logo appears on the cover. Dr. Silva is on the Advisory Panel representing AMWA.

February 7, 2008—Dr. Susan Ivey wrote a letter to her Senators in support of the Health Care Improvement Act which will improve the care of Native Americans.

February 22, 2008—AMWA endorsed the position of the International Myeloma Foundation that generic Thaliomide should not be released by the FDA to treat the cutaneous lesions of leprosy without the usual instructions contained for myeloma regarding the teratogenic effects.

March 3 2008—AMWA signed on to S. 2510 which is the Senate version of the Clinical Laboratory Improvement Amendments, HR. 1237, which AMWA endorsed May 8, 2007. This bill seeks to improve the diagnosis of cervical cancer.

March 5, 2008—AMWA signed onto the Senate version of HR4206, The Medicare Fracture Prevention and Osteoporosis Testing Act of 2007, sponsored by Senators Salazar and Snowe.

March 17, 2008—AMWA signed onto the Women and Health Care Coalition, a project of the National Family Planning and Reproduction Health Association. The mandate lists several congressional budget areas for women’s health.

March 18, 2008—AMWA signed on to the letter of support and thank you to Senators Salazar and Snowe for introducing the Medicare Fracture Prevention Osteoporosis Testing Act (S. 2702) / (HR4206).

March 23, 2008—AMWA endorsed the Washington State Initiative 1-1000 on Aid in Dying.

April 13, 2008—AMWA endorsed the letter to Members of Congress expressing support for the position of the FDA on its warning letters to the compounding companies making “Bio-identical” Hormone Replacement Therapy spear headed by the National Partnership for Women and Families. These compounds have not been approved by the FDA.

April 22, 2008—Dr. Omega Silva representing AMWA on the panel at the press conference of the National Consumers League and Shape Up America on The Need for Useful Labeling on Beer, Wine and Distilled Spirits held at the National Press Building.

April 22, 2008—AMWA endorsed the North American Menopause Society’s 2008 statement on the Hormone Position Statement which will be published in the July- August issue of the journal, Menopause.

May 8, 2008—AMWA signed on to the First Focus sign-on letter to President Bush and Secretary Leavitt regarding the August 17, 2007 SCHIP directive to request support and not a veto. AMWA is working with the National Association of Community Health Centers on this effort.

May 16, 2008—AMWA became a founding member of NWHAT, the National Women’s Health Agenda Task Force.

May 18, 2008—AMWA signed on to a letter to Senators Reid, McConnell, Grassley, and Baucus to support the inclusion of preventive benefits in S2115 which would extend the period of time for the Welcome to Medicare physical examination to one year instead of six months.

May 19, 2008—AMWA signed onto a letter to President Bush initiated by Planned Parenthood of America to request preservation of Title X family planning programs as a federally funded program.

May 21, 2008—Dr. Silva did not attend the Academy of Pediatrics meeting on 5/21/2008 for health care provider organizations which are supporting guaranteed access as an AMWA representative, but got a report and the Mayo Clinic’s and the Academy’s recommendations for a heath care plan from Robert T. Hall, JD, MPH who is the Assistant Director, DC Office (202)393-8600 Ext 3309, email rhall@aap.org.

June 11, 2008—AWMA sent a statement reiterating our position on HRT endorsed in the May 19, 2008 letter to Congress (see April 13 above) in response to the International Academy of Compounding Pharmacists’ rebuttal letter on its website accusing all the signers of that letter of being supported by Wyeth.

June 13, 2008—AMWA signed onto a letter requesting that Congress increase funding for the Infertility Prevention Program within the Centers for Disease Control initiated by ASHA.

July 26, 2008—AMWA signed on to the letter to President Bush asking him not to reduce contraception access; this action was initiated by the American College of Obstetricians and Gynecologists.

October 20, 2008—AMWA joined in on the tag line of a national TV spot which focused on why it is important to confront the candidates on what they will do to promote preventive care; it featured stars such as Lauren Bacall. Mark Blum helped to orchestrate AMWA’s involvement.

October 27, 2008—AMWA signed onto a letter from CARE asking the President to re-engage in the fight against global poverty.

November 3, 2008—AMWA signed onto an Amicus brief with the National Advocates for Pregnant Women in the case of Michelle Geiser Behles vs. North Dakota on her alleged abuse of prescription drugs while pregnant. She had a miscarriage.

November 10, 2008—AMWA signed on to a protest to Philip Morris with the Legacy Foundation to declare its Pink Purse Packs a veiled attempt to attract more women victims into the smoking population.

November 12, 2008—AMWA signed onto two letters to make healthcare reform a priority. The first goes to President-elect Obama to make the subject a main concern by calling a healthcare summit. The second goes to Congressional leaders to do the same in the 111th Congress. These initiatives were spearheaded by the American Cancer Society Cancer Action Network, SEIU, the Catholic Health Association and Families USA with the Herndon Alliance

November 18, 2008—AMWA signed onto a letter to the FDA Obstetrics and Gynecology Devices Advisory Committee urging a favorable decision regarding the use of the female condom especially because of its protection against HIV/AIDS.
December 29, 2008—The ACLU and National Advocates for Pregnant Women posted a victory in the Lovill vs. Texas case AMWA signed onto on January 18, 2008.

January 6, 2009—AMWA singed on to a letter to President-Elect Obama to tackle the national problem of overweight and obesity in children and adults as they are an epidemic that needs to be addressed as part of the healthcare problem. The letter was initiated by the Center for Science in the Public Interest.

January 17, 2009—AMWA signed onto a letter to the Senate initiated by the National Center for Immigrant Women’s Rights urging the Senate to pass the reauthorization of the SCHIP program which now includes immigrant children.

January 28, 2009—AMWA signed onto a letter to Senator Baucus requesting special consideration be given to women’s health, that specific items be included, and that uninsured women be included in any bill emanating from his committee, The Senate Committee on Finance. This effort is being lead by the National Women’s Law Center.

January 31, 2009—Dr. Omega Silva attended the Herndon Alliance annual meeting at the Mayflower Hotel at which its 2009 board was ratified and listened to presentations on healthcare moderated by Bob Crittenden with survey research by Celinda Lake on the Cost of Doing Nothing, Public Plan by Richard Kirsch with Healthcare for America Now, Anthony Wright of Health Access California and Ron Pollack of Families USA on state and national work to maximize chances for national reform. The group agreed it must be done this year or never and the president’s budget must get the ball rolling. The discussion was centered on effective ways to push the process.

February 16, 2009—AMWA signed on to a letter generated by the Alliance for Justice regarding the Medical Device Safety Act which advocates especially for women who may be harmed by devices marked specifically to control women’s reproductive health.

March 3, 2009—AMWA signed onto a letter initiated by the Society for Women’s Health Research to urge congressmen to sign on to sponsor HR1032, the HEART for Women Act, which would bolster efforts for research, education and heart disease screenings for uninsured and underinsured women.

March 4, 2009—AMWA sent a letter to the Deputy Managing Editor of the Associated Press concerning the media reports on the Final Exit Network which has been charged with assisting suicides in Arizona. The media seems to have confused legal aid in dying
with assisting suicides.

March 27, 2009—AMWA decided to partner with Physicians for Reproductive Choice and Health to sponsor a day of lobbying on the Hill on June 12, 2009 to advocate for the Reproductive and Sexual Health bill. We will have training on the bill and how to lobby on the 11th sponsored by PRCH for only 15 AMWA members who will sign up for the day to participate in the program at the Hyatt Regency on the Hill. The Policy and Advocacy committee prepared an announcement for the event at our meeting at the Annual Meeting on March 22, 2009 in Williamsburg which should be in circulation soon.

April 27, 2009—AMWA has teamed up with the National Academies of Practice to bring patients’ and practitioners’ voices to health care reform sometime in mid May when it is anticipated the bill will be completed and a hearing will be held.

May 19, 2009—AMWA has joined the National Physicians Alliance and the American Medical Student Association to push for a Public Heath Plan in the health care reform options. Individual members will sign on by email.

May 25, 2009—AMWA signed onto the Medical Amicus Brief, Baxter v. Montana in the interest of providing aid in dying. Other parties include the AMSA, Drs. Deric Weiss, Kathryn Borgenicht and Donald Hicks.

June 2, 2009—Drs. Omega Silva and Mary Alice Crockett participated in the National Academies of Practice and Coalition’s Call to Action~Support Healthcare Reform at the Rayburn Building Judiciary Committee Room 2237. On the Frontlines: Providers and Patients Alert Congress about Access, Choice and Coordinated Care included NAP officers, Marie DiCowden, PhD and Mary Costanza, MD, and four patients’ stories as well as Barbara Ross-Lee, DO, Dean New York College of Osteopathic Medicine on the public option. Legislative Aids from Congressmen John Conyer’s, Barney Frank’s, and Wexler’s offices spoke on their congressman’s hopes for a universal health plan to be enacted during this term. The NAP proposes the Medical Home and Community Home as well as an At Home model for health care all with coordinated interdisciplinary care.

June 9-10, 2009—Drs. Omega Silva and Mary Alice Crockett attended the Fracture Prevention Coalition’s day on the Hill for the reception on Tuesday the 9th and the Briefing on Wednesday the 10th of Osteoporosis and DXA: A Role Model for Chronic Disease Prevention. AMWA is a member of the coalition.

June 10, 2009—AMWA was asked by the National Consumers League to participate in the Best Privacy Practices Coalition it was forming to ensure that pharmacy communications protect patient privacy. Linda Golodner, a former president of the League and someone with whom Dr. Omega Silva had worked previously, asked Dr. Silva to join them. Most of the work will be done by email.

June 11-12, 2009—AMWA and Physicians for Reproductive Choice and Health participated in a lobby day for health care reform to include among other items reproductive health care for women. Thursday the 11th was spent on lobbying 101 with role playing and practice for the meetings with Representatives and Senators on Friday the 12th. PRCH provided the speakers and set up the meetings and Maggie Juliand of Representative Louise M. Slaughter’s office did the insider’s prospective. Drs. Bea Desper, Roberta Gebhard, Claudia Morrissey and Omega Silva, Nancy Hicks, and several medical students represented AMWA.

June 17, 2009—AMWA signed onto a coalition letter in response to a request by Senators’ Snowe and Mikulski to gather support for the inclusion of the offices of women’s health in the HELP committee’s health reform legislation, formally known last Congress as S. 612, or the Women’s Health Office Act. The request came from the Society for Women’s Health Research.

June 18, 2009—Dr. Omega Silva attended a White House meeting with physicians on healthcare in the context of prevention and cutting costs with Drs. Zeke Emanuel, Bob Kocher, Kavita Patel and Dora Hughes co-moderating the discussion. Dr. Silva’s suggestion on preventing obesity by having retired physicians engage children in discussions to educate them about nutrition and health with the eventual goal of changing attitudes about food was recorded at HeathReform.gov. She commented on the difficulty of treating obesity.

June 27, 2009—AMWA signed onto an Amicus Brief with the National Partnership for Women in the case of Reeves v C. H. Robinson Worldwide, Inc on sexual harassment in the work place.

July 9, 2009—AMWA signed on to Senator Milulski’s amendment 201, the Women’s Health Amendment, to ensure that health care reform meets the needs of women.

July 12, 2009—AMWA signed onto a letter urging Congress to include the Medicare adult day care services act in health care reform along with 75 other organizations. This effort was spearheaded by the Alzheimer’ Foundation of America and the American Academy of Neurology Professional Association.

July 15, 2009—On Wednesday July 15, 2009, a group visited the Hill on behalf of the National Physicians’ Alliance to which AMWA belongs. AMWA’s name appeared on the Alliance cover letter.

The following people attended:

Jamie Moran, MD, MPH Hospitalist, Shady Grove Hospital, NPA member
Krishnan Narasimhan, MD, Assistant Professor, Howard University, NPA
Fareen Qurashi, AMSA medical student
Omega C. Logan Silva, MD, MACP, Past President, AMWA
Juanita Smith, MD, Hospitalist, Shady Grove Hospital, NPA
Sanjeev Sriram, MD Harvard Fellow, NPA
Pauline Titus-Dillon, MD, MACP, former Sen. Assoc. Dean, Howard University College of Medicine, AMWA member
Aileen Watchko, NPA Staff

We appeared in our white coats receiving attention from a reporter from the Washington Times as we assembled at the entrance to the Dirksen Senate Office Building. The prescriptions and letters from constituents were delivered in folders with information about the NPA with appropriate comments to staff to please support President Obama’s health reform plan and the public health option to the following Senators:

Lamar Alexander, TN
Evan Bayh, IN
Robert Bennett, UT
Christopher Bond, MO
Richard Burr, NC
Roland Burris, IL
Maria Cantwell,WA
Robert Casey, PA
Susan Collins, ME
Kay Hagan, NC
John Kerry, MA
Patrick Leahy,VT
Carl Levin, MI
Blanche Lincoln, AR
Edward Kennedy, MA
Mel Martinez. FL
John McCain, AR
Jeff Merkley,OR
Patty Murray, WA
Mark Pryor, AR
Bernard Sanders, VT
Olympia Snowe, ME
James Webb, VA
Mark Warner, VA

Many of the staff knew their Senator’s stand on the issue and some revealed that the Senator had not taken a public stance as yet. We commented that we hoped the letters and prescriptions from the senator’s constituents would positively influence the final vote of those undecided and coerce those against the plan to support the plan.

Senator Blanche Lincoln who was just leaving as we approached returned to greet us and mentioned that she was late for a committee meeting on the plan which she supports.

Since we did not have time to deliver all the packets, Ms Watchko and the AMSA members delivered the remainder on the House side the next day.

July 19, 2009—AMWA signed onto HR 3200, the America’s Affordable Health Choices Act just released from the three relevant House Committees. It is the legislation President Obama is advocating be passed.

July 29, 2009—AMWA signed onto the amicus brief of the ACLU Reproductive Freedom Project of a 25 year old mother who had local government intervene in her care and demand that she go on prescribed bed rest even though she had two children at home. No offer of assistance with child care was tendered.

September 2, 2009—AMWA signed onto the letter from the National Coalition of Women’s Organizations to Congress outlining the requirements for women’s health that should be addressed in a health care reform bill especially the need for a public option.

September 9, 2009—AMWA signed onto the statement of the American Social Health Association to encourage the FDA to approve another vaccine for HPV for the two strains that cause 70% of the cervical cancers which will increase competition and therefore pricing and produce additional distribution channels. AMWA also endorsed the organization’s view that men and boys should be offered the Gardasil vaccine as well as females as they are affected by many HPV caused diseases and could benefit from
vaccination.

September 9, 2009—Representing AMWA, Dr. Omega Silva attended the Town Meeting with Constituent Organizations held by Francis Collins, MD, PhD, the new NIH Director at 1:30 in the Natcher conference Center on the NIH campus.

Dr. Collins who trained as a chemist obtaining a PhD in that field, went to medical school and developed an interest in genetics when a teacher introduced the class to several patients with genetic problems—Downs syndrome, neurofibromatosis, galactosemia and others. He is delighted that President Obama sees science and openness as necessary for progress and that NIH exists to generate fundamental knowledge and to apply it to clinical medicine to make our lives better.

Dr. Collins sees opportunities in five areas:
1) Genomics as applied to fundamental biology in specific diseases.
2) Translating basic sciences into new and better therapies such as drugs and the use of public-private partnerships to develop the potential of the knowledge.
3) Putting science to work for health care reform with comparative effectiveness research and pharmacogenomics.
4) Global health with such diseases as malaria and schistosomiasis in cooperation with WHO and the Gates Foundation.
5) Reinvigorating and empowering the biomedical research community with training programs using the 10 billion NIH has received from the Recovery Act which will stimulate the economy, create and preserve jobs and advances biomedical research.

As Director he needs help in these areas:
1) Using the voices of the constituent organizations in support of medical research; let him hear your stories.
2) Describing NIH research to the public and Congress.
3) Communicating with wide open channels; let him hear of issues your organization would like NIH to consider.
October 5, 2009—Dr. Omega Silva participated as the AMWA representative to the National Physicians Alliance which along with the American Medical Students Association organized the National Grand Rounds on Health Care Reform. Dr. Silva posed a question on whether for profit health care organizations can be expected to provide care compatible with a universal health care model.

It was an informative experience for those colleagues in the audience as well as those on the web listening to the moderator, Dr. Arthur Kellermann and the distinguished panelists, Dr. Stephen Cha, Dr. Meena Sheshamani, and Dr. John McDonough giving their insightful answers. There were over 100 physicians and medical students attending in person in Washington DC at the Columbus Club in Union Station and approximately 1,000 physicians watching from around the country.

This is an exciting time for the medical profession, and hopefully this event furthered our understanding of the current debate on health care reform and our place within it as physicians or future physicians. Please share this event with colleagues through the archived webcast video at: http://www.visualwebcaster.com/event.asp?id=62620 . The webcast will be available until the end of the calendar year.

The inaugural National Grand Rounds was a historic step in both educating physicians about health reform policy and in using state-of-the-art technology to reach a nationwide audience. The Alliance looks forward to developing similar events in the near future to build upon and improve on this event. Please take a few minutes to share your feedback on the online evaluation at http://www.surveymonkey.com/s.aspx?sm=D1w7D5lEp4hB_2fNwKJANtOw_3d_3d . Your input is greatly appreciated.

The American Medical Student Association (AMSA) and the National Physicians Alliance (NPA) Foundation will continue to provide you with the informational opportunities in this current debate and within health care policy. Please contact Dr. Valerie Arkoosh, President-Elect of the NPA at val@npalliance.net or Farheen Qurashi, Jack Rutledge Legislative Director of AMSA at jrld@amsa.org with questions or for more information.

October 12, 2009—AMWA signed onto a letter generated by the Family Planning Coalition to OMB to request an increase in the funding for Title X family planning programs to $700 million over the next five years.

October 14, 2009—AMWA signed onto an amicus brief known as Blick et al vs. CT. This brief asks the court to clarify that when physicians provide aid in dying to mentally competent, terminally ill patients, they do not violate Connecticut’s statute which makes assisting another to “commit suicide” a crime. The suit asks the court to declare that the physicians would not be subject to criminal prosecution under existing CT law if they provide a prescription for medication to a mentally competent terminally ill patient, which the patient could consume to bring about a peaceful death.

October 18, 2009—AMWA signed onto a letter generated by the MergerWatch Project to suggest that physicians support Senator John Kerry’s amendment to the health reform bills to empower the health insurance “exchanges” that would be created by reform legislation to act on behalf of consumers to negotiate good prices and values. This is a great way to improve affordability of health insurance within the exchanges – an important priority for women and our families.
October 19, 2009—AMWA signed onto a letter generated by Senator Barbara Mikulski asking the Finance Committee to “Close the Insurance Market Reforms Loophole in the Finance Health Reform Bill: Apply the Insurance Market Reforms, such as the ban on gender and health status rating, and limits on age rating, to all groups, regardless of size
and without any phase-in”.

November 5, 2009—Dr. Omega Silva participated with others in the National Alliance of Physicians (AMWA is a member of the coalition) in a day of visiting Representatives who were committed to the House Health Reform bill HR 3962 to thank them for their support and remind them that 500, 000 Physicians supported reform and a public option and to counteract the negativity generated by the Tea Party demonstration gathered by Rep Michele Bachmann (R). We left a poster with the names of the medical organizations behind the bill.

November 5, 2009—AMWA and others signed onto a letter generated by the National Research Center for Women and Families asking the FDA to reclassify tanning beds as Class III Devices which are carcinogenic.

December 1, 2009—AMWA signed onto a letter which is to go to all Senators urging them to support Senator Mikulski’s Women’s Health Amendment to the Health Reform bill to ensure that women will have all the necessary preventive services.

December 8, 2009—AMWA signed in support of Senator Menendez’s amendment to the Patient Protection and Affordable Care Act which permits young women who become pregnant while enrolled in a catastrophic health insurance plan to immediately and seamlessly enroll into a comprehensive plan with affordable maternity benefits.

December 8, 2009—AMWA signed onto a letter to Senators Reid and McConnell generated by the Partnership to Fight Chronic Disease which requests a special focus in the Healthcare Reform Bill on improving health by addressing the burden of chronic disease by supporting policies that empower people to engage in healthy behaviors and to seek, access, and follow through on recommended care; enhance preventive health services in Medicare and Medicaid; improve are coordination; and reduce and eliminate health disparities.

December 15, 2009—Dr. Omega Silva participated in the AMWA Student Woven Word Webinar at Touro College of Osteopathic Medicine in New York as the Moderator and Keynote Speaker with Siatta Dunbar, the Chair of Advocacy at the College Chapter, Misty Richards, the AMWA National Student President, Genevieve Grabman of Physicians for Reproductive Choice and Health and Esha Pandit of Raising Women’s Voices for the Healthcare We Need. The webinar on Healthcare was the kick-off for the assembly of the making of a quilt symbolizing their hopes. The quilt will be on display at the annual meeting in DC in March.

December 17, 2009—Dr. Omega Silva and Shelly Choo, the president of the Asian Pacific American Medical Students Association, were invited by the Associate Director of the White Office of Public Engagement through Dr. Elena Ong of APAMSA’s advisory board and AMWA to tour the Christmas White House. Some of the photographs taken by Ms. Choo were posted on the AMWA website.

January 27, 2010— Dr. Omega Silva represented AMWA at Cervical Cancer Day on the Hill presented by Tamika and Friends in the Rayburn Building. January is Cervical Cancer Month. The Honorable Rosa L. Delauro (D-CT) spoke about Prevention and Early Detection and mentioned her own survival from ovarian cancer.

January 27, 2010—AMWA signed onto the house health reform bill, Affordable Healthcare for America Act (HR 3962).

January 30, 2010—AMWA signed onto a letter to friends on the Hill and the administration generated by the Family Planning Coalition to highlight the efficiency and effectiveness of Title X family planning programs and to urge their inclusion in the budget. The letter asks for an increase of $700 million over five years for the Title X program, beginning with an increase of $76.5 for Fiscal Year (FY) 2011. Additionally, it asks for the inclusion of language in the FY 2011 Labor, Health and Human Services and Education Appropriations Committee Report requesting updating of Title X program guidance and administrative rules as needed, which would allow Title X health centers to better serve patients. Finally, it requests a $10 million increase in funding for the Infertility Prevention Program (IPP) at the CDC.

February 1, 2010—AMWA signed onto a reauthorization of the Family Violence Prevention and Services Act (HR 4116) requested by the National Task Force to End Sexual and Domestic Violence.

February 3, 2010—AMWA signed onto an amicus brief from the Center for Reproductive Rights to endorse the brief which asks the courts to enforce the California ordinance that protesters at reproductive health care clinics remain eight feet away from the entrance to the clinic in the Ninth Circuit Court. The Amicus brief went forward as Hoye, ll v. the city of Oakland with Janet Crepps and Jennifer Mondino as attorneys fot the CRR.

February 10, 2010—AMWA signed onto a letter to Congress generated by the Coalition for Health Funding to secure increased funding for the public health continuum and the agencies of the Public Health Service—NIH, CDC, SAMHSA, HRSA, AHRQ, FDA, and the Indian Health Service.

February 16, 2010—Drs. Omega Silva and Pauline Titus-Dillon, representing AMWA, attended the talk on What Keeps Women Up At Night:A Woman’s Health Initiative Presented and Hosted by Sanofi-aventis U.S. at Zola restaurant in DC given by Michele Polz, Sr. Director, Customer Data Strategy Innovation G New Customer Channels.

February 24, 2010—AMWA signed onto a letter generated by the American STD Directors and the American Social Health Association to Congress to increase funding to the Division of STD Prevention at CDC. STD rates are rising and funding has eroded.

March 3, 2010— On March 3, 2010, AMWA President-Elect Eliza Chin and AMWA Past President Claudia Morrissey attended President Obama’s White House Press Conference on Health Reform. AMWA Supports President Obama’s Healthcare Reform Proposal on International Women’s Day. Here is the letter.
American Medical Women’s Association 100 North 20th Street ● 4th Floor, Philadelphia, PA 19103 ● Telephone (215) 320-3716 ● Fax: (215) 564-2175 ● www.amwa-doc.org March 7, 2010

President Barack Obama

The White House 1600 Pennsylvania Avenue NW Washington, DC 20500
Dear President Obama, The American Medical Women’s Association (AMWA) is “The Vision and Voice of Women in Medicine.” Founded nearly a century ago, AMWA is the nation’s oldest women’s multi-specialty organization dedicated to advancing the status of women’s health and the advancement of women in medicine. We believe in equality and equal opportunity so women can achieve their full professional and personal potential. We believe in equal opportunity in education, employment and access to health services to include women’s wellness and a woman’s right to choose.
Mr. President, we write today to applaud your visionary leadership to create and sustain a Healthier America. We support the principles you laid forth in the Bicameral Health Care Summit of February 25, 2010, and support your efforts to advance legislative language that will: 1. expand access to high-quality, client-centered services for at least 31 million more uninsured, 2. ensure that clients are not discriminated against based on gender, pre-existing condition, income, race and ethnicity, 3. offer a full range of women’s wellness services, and protect a woman’s right to choose, 4. expand training opportunities in women’s wellness, reproductive health, and domestic violence, to advance women’s equality, 5. provide for Medicare, and 6. protect our most vulnerable, by ensuring that every state has a health care safety net (Medicaid and CHIP)
Mr. President, this Women’s History Month, AMWA is proud to stand with you, to advance the goals of your Health Reform Proposal, and get Health Reform signed into law. Our patients, their families, and the women, men and children of America, deserve no less. The time for Health Reform is now!
Mr. President, if there is anything we can do to help you pass and implement Health Reform, know you can call on AMWA. Nothing would be more exciting than to celebrate the successful passage of Health Reform at AMWA’s 95th Anniversary Gala in Washington, DC on March 27, 2010. We truly hope that you, First Lady Michelle Obama, and DHHS Secretary Sebelius can join us.
For America’s Health,

Beatrice Desper, MD Eliza Lo Chin, MD, MPH
2009-2010 AMWA President Incoming 2010-2011 AMWA President
cc: AMWA Advocacy Committee, AMWA Executive Board, Elena Ong

March 11, 2010—AMWA signed onto a letter generated by the National Center for Research for Women and Families to the FDA pressing it to “Strengthen the Center for Devices and Radiological Health’s 510(k) Review Process [Docket No. FDA-2010-N-0054]”.

March 12, 2010—AMWA signed onto a letter generated by ACOG to Congressman Obey and Tiahrt of the Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies to fund research and programs to improve child and maternal health as the USA is behind many nations in indices related to those entities, but yet spends much more money in these areas.

March 15, 2010—AMWA signed onto a letter generated by the APHA to set funding for the Health Resources Services Administration at $9.15 billion in the Labor, Health, and Human Services and Education Appropriations bill for FY 2011.

March 16, 2010—AMWA Students and others marched for Health Care Reform on Monday March 22, 2010 in Washington, DC prior to the Annual Meeting in Arlington, VA. The Students also arranged a virtual march on their facebook page for those unable to march in person. ACP physicians also marched.

March 24, 2010— On March 24, 2010, AMWA and PERCH jointly had an advocacy day on the Hill. Genevieve Grabman and Kelly Baden of PERCH briefed the group on the issues relating to the Healthcare Reform Bill—that we wanted the House Bill passed in the Senate with no amendments. In the future we can tweak the things which should be changed. Our group included AMWA and PERCH leaders—Jodi Magee, the PERCH president and CEO; AMWA past presidents, Omega C. Logan Silva, MD and Deborah Judelson, MD; PERCH president, Frances Batzer, MD; AMWA president-elect, Eliza Chin, MD and AMWA president elect-elect, Mary Guinan, MD, PhD. We visited with Michael Hogan associate chief of staff to Senator Ben Nelson, Diane DiSanto of Senator Begich’s office, Heather O’Loughlin of Senator Baucus’ office, Jackie Stewart of Senator McCaskill’s office, and Carolyn Gluck of Senator Reid”s office. Our message to all of them was thanks for all the time spent on healthcare reform and that our groups were ready and willing to use our expertise in refining the bill which we witnessed passing 56 to 43 on the TV in Senator Baucus’ office as the roll call of Senators was called. Senator Begich’s Ms. DiSanto was especially interested in the VA. Dr. Silva volunteered her knowledge of the VA as she had been involved as a physician for 29 years and had served on the charter committee on women veterans. Carolyn Gluck invited the group to view DC from the balcony of Majority Leader Reid.

March 26, 2010—AMWA signed onto a letter generated by the National Family Planning and Reproductive Health Association to its Family Planning Coalition Members to The House Committee on Appropriations to repeal the Global Gag Rule which prohibits family planning overseas; even though President Obama lifted the policy within a week of assuming his office, we fear reversal in the future if a permanent law is not implemented.

May 8, 2010—AMWA signed onto a letter generated by National Family Planning and Reproductive Health Association to the Secretary of HHS (Secretary Sebelius) asking that that the Title X family planning program receive FY 2010 funding from the Prevention and Public Health Fund established in the “Patient Protection and Affordable Care” Act.

May 25, 2010—AMWA will endorse a PRCH statement to the FDA on a new prescription only emergency contraceptive drug, Ulipristal, which is effective for 2-5 days after unprotected sex or failed contraception for preventing pregnancy. It is to be reviewed at the FDA Reproductive Drug Committee meeting on June 17, 2010.

June 5, 2010—AMWA endorsed the California Bill SB1291 (Leno) in support of legislation will that will require that flame retardant chemicals used in furniture, juvenile products, bed coverings, and bedding products be reviewed under the provisions of the Green Chemistry initiative and require that the Department of Toxic Substances Control perform a comparative hazard assessment of these chemicals prior to their use.

June 6, 2010—AMWA signed onto a letter generated by the National Women’s Law Center to urge the Senate to include extended FMAP and COBRA funding in HR4213 when the Senators return next week to take up the bill. Unfortunately, the House passed their bill after the additional 6 months of Medicaid FMAP funding and COBRA subsidies were removed. We are hopeful that the Senate will restore those funds in their bill.

June 8, 2010—AMWA signed on to an additional letter to the leaders of the House and Senate on the extension of COBRA in the American Jobs and Closing Tax Loopholes Act of 2010 as it was not in HR4213 (see above).

June 8, 2010—AMWA signed onto a letter to Secretary Sebelius (HHS) stating AMWA’s willingness to work with her to implement the Health and Human Services (HHS) components of the Prevention and Wellness Fund, the National Prevention, Health Promotion, and Public Health Council, and the Women’s Health Amendment within the health care reform bill. This letter is to begin a dialogue on these opportunities within the health care reform bill and the need for additional support to prevent violence and abuse.

June 8, 2010—AMWA supported a resolution recognizing the achievements of the Title X family planning program. The resolution will be introduced shortly, and Rep. Chu’s office will include a list of organizations that support it when introduced.

June 8, 2010—Dr. Omega Silva attended the 40th anniversary celebration of the Coalition for Health Funding held in the Caucus Room of the Cannon House Building. Louis Sullivan, MD former Secretary of HHS and David Rutstein, MD, MPH, Assistant Surgeon General were speakers and three awards were given.

June 12, 2010—AMWA signed onto a letter to Rep. DeLauro, chair of the House Appropriations Subcommittee on Agriculture, Rural Development, generated by the National Research Center for Women and Families to consider language in the upcoming PDUFA (Prescription Drug User Fee Act) V (the fifth renewal) legislation that would bar the Food and Drug Administration (FDA) from accepting outside interpretations of the
results of susceptibility testing for antibiotics, and that would prohibit FDA from outsourcing the task of determining or evaluating the effectiveness of antibiotics, whether new or old.

July 8, 2010—AMWA signed onto a letter generated by the National Research Center for Women and Families to the FDA to express our very strong support for the conference grant proposal submitted by the National Research Center for Women & Families to convene at least two meetings on behalf of patient, consumer, and public health organizations regarding Center for Devices and Radiological Health (CDRH) issues. The goal of the proposed working conferences is to increase the knowledge and participation of individuals and non-profit patient, consumer, and public health organizations that care about FDA regulatory activities but have had limited participation in CDRH meetings and written comments.

July15, 2010—AMWA endorsed the section on alcoholic beverages in the 2010 Dietary Guidelines for Americans which now emphasizes consuming alcohol in terms of a weekly average rather than daily limits as most people do not drink everyday.

July 19, 2010—AMWA signed onto a letter generated by the Sexuality Information and Education Council of the USA to urge the Obama administration to zero out funding for the failed Title V abstinence-only-until-marriage program in the President’s Fiscal Year 2012 Budget Request. The Title V abstinence-only-until-marriage program expired on June 30, 2009, but the program was unfortunately resurrected in recent health care reform legislation. The extension totaled $250 million for failed abstinence-only-until-marriage programs over the next five years (2010–2014).

July 19, 2010— AMWA signed onto a letter stating our strong objection to the administration’s decision to prevent women from using even their own private funds to pay for abortion coverage in the new pre-existing condition insurance plans. During the debate on health care reform, Congress rejected the Stupak amendment, which would have banned abortion from being covered in any insurance plan that received even one dollar of funding under the Affordable Care Act. The administration has now, in effect, imposed this amendment on high-risk insurance plans for people with pre-existing conditions without justification in law or policy. This decision will prevent women with serious pre-existing medical conditions from getting the abortion coverage they need to protect their health, even when they pay for such coverage themselves. We urge the administration to reconsider its decision and restore the coverage that Congress intended to be available under The Affordable Care Act.”

July 21, 2010— After a great outcome from the FDA Reproductive Health Drugs Advisory Committee meeting on ella in June, AMWA, along with National Women’s Health Network (NWHN) and the National Research Center for Women and Families, have put together a short letter addressed to FDA Commissioner Hamburg recognizing and appreciating the scientifically-based approval process of ella thus far.

August 16, 2010—AMWA signed onto the Compassionate Assistance for Rape Emergencies (CARE) Act. It will ensure that sexual-assault survivors learn about emergency contraception (EC) in hospital emergency rooms and are provided the medication upon request.

August 16, 2010—AMWA signed onto a letter to the Secretary of HHS and the National Association of Insurance Commissioners generated by the EQUAL Health Network urging attention to the Section 2718 of the ACA which establishes minimum Medical Loss Ratios (MLR) to “bring down the cost of health care coverage” and “ensure that consumers receive value for their premium payments.” It requires health insurance
companies in the large market to spend at least 85% of premiums on patient
care, and only 15% on administration and profit. In the small group/individual market, the figures are 80% MLR and 20% for administration and profit.

August 24, 2010—AMWA signed onto a letter generated by the National Women’s Law Center to strengthen proposed regulations issued by CMS to ensure inclusive hospital visitation policies. The rule has the potential to help ensure that all people have the ability to have their chosen loved one visit with them when in the hospital and is found in Proposed Rule on 42 CFR Parts 482 and 485, “Changes to the Hospital and Critical Access Hospital Conditions of Participation to Ensure Equal Visitation Rights for All Patients.”

August 30, 2010—AMWA signed onto an Amicus Brief generated by the National Women’s Law Center to support a woman engineer who felt she was discriminated against in salary and was harassed in the work place and her fiancée was dismissed after she filed suit against her employer, a producer of stainless steel.

September 2, 2010—AMWA signed onto a letter generated by the National Family Planning and Reproductive Health Association to the Senate Armed Services Committee supporting an amendment to the National Defense Authorization Act that would repeal the ban on using private funds to obtain abortions at military treatment facilities. Prohibiting women from using their own money for abortion services endangers their health, safety and dignity. Under current law, servicewomen and military dependents can access abortion services at military facilities only in the cases of life endangerment, rape, or incest.

September 7, 2010—AMWA signed onto a letter to the Gestational Diabetes Prevention Act which is being reintroduced to the House by Congressman Eliot Engel. It is the same bill introduced in the Senate by then Senator Clinton in 2006. AMWA then president, Dr. Susan Ivy, wrote the AMWA sign-on letter to Senator Clinton.

September 13, 2010—Drs. Claudia Morrissey, Norma Jo Waxman, and Omega L. Silva participated for AMWA as a cooperating organization for the roundtable meeting entitled, “Hormonal Contraception Update 2010: A Decade of Innovation & Transformation” on September 13, 2010 in Washington, DC presented by the The Society for Women’s Health Research (SWHR) and sponsored by the Potomac Center for Medical Education with educational partner, Rockpointe. The roundtable conference was held at The Liaison Capitol Hill Hotel in Washington, DC. The latest data on contraception was presented by Drs. Philip D. Darney, Anne Burke, Jennifer Frost, Florence Hasteltine, Jeffrey T. Jenson, Uta Landy, Lee P. Shulman, Carolyn Westoff, and Susan Wysocki.

September 20, 2010—AMWA signed onto a letter generated by the American Heart Association to support the Heart for Women Act passed by voice vote in the House Energy and Commerce Committee.

September 24, 2010—AMWA signed onto a letter to stating that AMWA members believe the ban on abortion coverage that the White House and HHS imposed on the Pre-existing Condition Insurance Plans was both legally unnecessary and extremely harmful. It fails to recognize that continuing a pregnancy can seriously jeopardize the health of women with pre-existing conditions like cancer, heart disease and kidney disease. Health reform was supposed to end denials of coverage to people with pre-existing conditions, not institute a new form of denial! This letter was generated by the National Women’s Health Network and sent to Secretary of HHS, Kathleen Sebelius, asking her to rescind the ban.
October 6, 2010—AMWA signed onto a letter to OMB requesting specific increase in the Title X budget to $60 million in FY 2012 to strengthen family planning provisions. The letter was generated by the Family Planning Coalition.
October 7, 2010—Dr. Omega Silva attended the National Consumers League Awards dinner and program as the guest of the Distilled Spirits Council of the US with which AMWA provides nutrition consultations. The league honored Dr. Regina Benjamin, the Surgeon General and Kenneth Feinberg, the compensation czar.
October 13, 2010—AMWA signed on to a letter generated by the American Bar Association ‘s Commission on Law and Aging recommending that Compassion and Choices be approved as a nongovernmental organization member in the department of Public Information at the United Nations.
October 18, 2010—AMWA signed on a letter from the Friends of HRSA to key members of the House and Senate Appropriations Committees to provide the highest funding to the agency for FY 2011 in order for the agency to achieve its ultimate mission of ensuring access to culturally competent, quality health services; eliminating health disparities; and rebuilding the public health and health care infrastructure. A similar letter was sent to the leaders of the House and Senate.

October 25, 2010—AMWA signed onto a letter generated by the National Research Center for Women and Families to the Energy and Commerce Committee of the House to improve the safety of medical devices which would require clinical trials similar to those for prescription drugs as the FDA would like with post approval reviews.
December 2, 2010—Dr. Omega Silva attended the launch of HHS’s Healthy People 2020 which was introduced by panel of distinguished speakers including Dr. Howard Koh, the Assistant Secretary of Health, and members of the Secretary’s Advisory Committee on National Health Promotion and Diseases Prevention Objectives for 2020. Dr Cathy Baase of Dow Chemical was one of the speakers.

December 5, 2010—AMWA signed onto a letter to the FDA generated by the National Research Council for Women and Families. Members of the Patient, Consumer, and Public Health Coalition support generic drug user fees so that the FDA can hire more staff to address the backlog and to review new applications more quickly. User fees should not be tied to approval time performance goals for specific drugs. We support reduced fees for small companies if those companies do not delay the marketing of their approved generic products in the U.S. We support substantially higher fees for U.S. companies or foreign companies that do not market an approved generic drug in the U.S. in a timely manner. We also support higher fees for applications, which require more work by the FDA. And, we support a percentage of user fees going to post-market
surveillance.

December 7, 2010—AMWA signed onto a letter Doctors for America would like to send to Congress to publicize physician and medical student support for the Affordable Care Act (ACA) as the 112th Congress begins the week of January 3rd. The incoming leadership of the House has repeatedly declared that they have a mandate to halt the ACA. The goal is to put pressure on the new Congress to work with physicians to move health reform forward. The first part of this effort is a petition from individual physicians and medical students to the incoming leadership in the House. Individuals have an opportunity to sign the letter and to share their patient stories. To date, hundreds of signatures and dozens of moving stories and statements from physicians and medical students across the country have been collected.

December 13, 2010—AMWA signed onto the San Antonio Statement on Brominated and Chlorinated Flame Retardants statement published in EHP (Environmental Health Perspectives—a publication of the National Institute of Environmental Health Sciences.)

January 3, 2011—AMWA signed onto, cosponsored, and reviewed the American Heart Association’s Effectiveness-Based Guidelines for the Prevention of CVD in Women. It encompasses clinical recommendations for risk factor management targeted to primary care physicians and women’s health care providers and is based on current evidence. More than 30 experts representing a dozen cosponsoring organizations have voted to rate evidence and have come to consensus on the clinical recommendations. (Note: Dr. Debra Judelson is AMWA’s representative on the Expert Panel.) All cosponsoring organizations reviewed the paper, and in addition, 3 peer reviewers have evaluated the guidelines.

January 8, 2011—AMWA signed onto a letter to the House of Representatives from organizations committed to protecting and improving women’s health strongly urging the House members to vote against HR2 and HR9, which would repeal the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as “the Affordable Care Act.”) These two laws are already providing critically important benefits and protections for women and their families. In short, repealing these critically important laws would harm women and their families, and would once again allow insurance companies to treat women like a pre-existing condition. Repeal would harm women in many specific ways. Repeal would allow unfair and discriminatory insurance practices that are particularly harmful to women to continue. Repeal would make obtaining insurance harder and more expensive. Repeal will make finding comprehensive health insurance more difficult. Repeal will eliminate critical tax credits for small employers, making it harder for them to provide insurance coverage for their employees. Repeal will reinstate the Medicare drug coverage gap. Repeal will eliminate many additional provisions providing important benefits to women and their families.

January 16, 2011—AMWA signed onto a letter to the FDA as a member of the Patient, Consumer, and Public Health Coalition, which wants to emphasize that its appreciation for the wonderful life-saving benefits of many medical devices, even while it expresses concern that improvements to the 510(k) process are needed to reduce the number of patients whose lives are put at risk by medical devices whose risks outweigh the benefits for them. The letter was generated by the National Research Center for Women and Families. The Coalition supports the following:
1. Public health will be improved if FDA requires clinical trials for high risk devices. FDA needs to rethink its risk categories for medical devices, and should determine the risk level of device based on what happens if it fails, as well as what happens if it works. In other words, if an elective device can kill you if it fails, that’s a high-risk device.
2. FDA needs clear and expanded authority to do pre-market and post-market inspections of 510(k) devices.
3. FDA needs clear and expanded authority to require post-market studies of 510(k) devices.
4. FDA needs to make better use of its rescission authority for 510(k) devices, and improve or expand that authority if necessary.
5. FDA needs a more stringent definition.

February 7, 2011—AMWA signed onto a letter generated by Planned Parenthood to the Speaker of the House, John Boehner, asking that he and the House focus on providing healthcare for women and families and not on attacking the 90 year old organization with coordinated efforts to defund it. 3 million persons now depend on Planned Parenthood for their primary in many cases in 850 centers throughout the States.

February 7, 2011—AMWA signed onto a letter to Secretary Clinton (State Department) generated by Women Thrive concerning the Quadrennial Diplomacy and Development Review (QDDR) which was unveiled in December 2010. It is essentially an assessment of all U.S. diplomacy and international aid efforts and a comprehensive blueprint for how to do it better going forward.

What is historic is that the QDDR puts women and girls at the center of the strategy which impacts
tens of billions of dollars worth of funding. Women are usually the ones left behind, so the QDDR’s
emphasis on ensuring that both women and men’s unique circumstances are considered in the breadth of all U.S. foreign policy and aid is a landmark change. When implemented, these reforms will result in real improvements in the lives of countless women, girls, and also for their families and communities around the world, especially since investments in women yield greater benefits in terms of the health and education of children and families. This letter outlines recommendations regarding integration of gender in the QDDR.

February 8, 2011—AMWA created a statement for Senator Barbara Boxer to use for her committee’s fight to preserve the Affordable Care Act.
AMWA’s Position on HR 3 and HR 217
AMWA supports unrestricted access to and insurance coverage for reproductive healthcare for all women. This includes access to and payment for legal abortion. One in three American women will have an abortion in her life time. AMWA strongly opposes Bills HR 3 and HR 217 as they will further restrict access to a procedure that is legal and should be safely available to all women.

February 23, 2011—AWMA signed onto a brief by the National Women’s Law Center supporting the Affordable Care Act in the Fourth Circuit Court.

March 29, 2011—Representing AMWA, Dr. Omega Silva attended the reception of the National Family Planning and Reproductive Health Association to celebrate the 40th anniversary of Griswold vs. Connecticut which resulted in the later passage of Title X, the federal program for family planning.

April 3, 2011—On March 31, 2011, the beginning of AMWA’s annual meeting, AMWA members participated in a Capitol Hill Advocacy Day with the Physicians for Reproductive Choice and Health. Groups according to geographic location met with federal legislators. The topic for this year was legislative efforts to restrict funding for Title X, the federal family planning program. AMWA signed onto a letter to be given to each office stating the position of the groups. As a group, we had over 50 meaningful and productive meetings, educating legislators and their staff about the importance of funding Title X and Planned Parenthood. Thanks to your enthusiastic participation, Federal Advocacy Day was a great success.

April 6, 2012—AMWA signed onto a letter of support for Representative Louise Slaughter who plans to introduce a bill to reauthorize the Health programs of The Violence Against Women Initiative Act of 2011.

April 12, 2011—AMWA signed onto a letter supporting Dr. Donald Berwick to head CMS generated by the National Physicians Alliance.

April 12, 2011—AMWA signed onto a letter supporting the funding of Planned Parenthood and a vote against the Pence Amendment to be sent to selected members of Congress. “The American Medical Women’s Association, an organization of women physicians, medical students, and residents values equality for women and equal opportunity for women to achieve their full professional and personal potential. AMWA’s mission is to support policies and programs that improve women’s health.

Planned Parenthood provides important services for women’s health. As noted by the President of Planned Parenthood, Cecile Richards, “The fact is that 97 percent of the health care Planned Parenthood provides is preventive, and every federal dollar Planned Parenthood receives goes toward providing preventive health care to women.” Defunding Planned Parenthood will be a detriment to women’s health and is not something that the American Medical Women’s Association can support.”—–Our statement.

April 25, 2011—AMWA signed onto a letter opposing a bill, HR3, a dangerous and extreme bill that would threaten women’s health by denying access to health insurance that includes coverage for abortion services, whether that insurance is public or private. The bill represents an unprecedented, radical new level of governmental intrusion into private medical decisions, and would impose new tax penalties on millions of families and small businesses. The American Civil Liberties Union is leading this effort.

April 25, 2011—AMWA signed onto an amicus brief being generated by Melissa Derr and others at the firm, Simpson Thacher & Bartlett LLP, 2550 Hanover Street, Palo Alto, California 94304 which concerns women who come to CPCs (Community Pregnancy Centers) to obtain an abortion and then discover that the CPC will not provide it (or refer them to a place that will) and are harmed from the delay inherent in this process. That delay can be prolonged – and the harm to these women thereby increased – if the women are not informed as soon as they enter a CPC that they must go elsewhere. The harm from the delay comes in two distinct forms: (i) increased risks posed by a later abortion and (ii) inherent risks of remaining pregnant under certain circumstances. Significantly, these harms are most pronounced for the very population of women who come to CPCs. This brief opposes the centers in Baltimore, MD and the Diocese of Baltimore and is to be heard in the United States District Court for the District of Maryland, Case No. 1:10-cv-00760 MJG, The Honorable Marvin J. Garbis. This amicus brief is in support of Baltimore City Ordinance 09-252, a first-in-the-nation ordinance that demands truth in advertising from limited-service pregnancy centers. This court process will be important for the country should it be decided in favor of Baltimore city.

May 3, 2011—AMWA signed onto a similar letter as the one on April 25th, this one generated by Raising Women’s Voices for the Health Care We Need to oppose HR 3, a bill which denies many benefits for women’s reproductive health.

May 5, 2011—AMWA signed onto a similar letter as the one on April 25th, this one generated by the Women’s Health Network to oppose HR 3, a bill which denies many benefits for women’s reproductive health. The more organizations oppose the bill, the more likely it will not pass in the House and certainly will not in the Senate and President Obama will veto it.

May 12, 2011—AMWA endorsed the Futures Without Violence coalition’s letter to garner supporters on the Hill for a reauthorization of the Violence Against Women Act with minor changes.

May 23, 2011—AMWA signed onto a letter to thank Rep. Susan Davis (D-CA) and some others who are filing an amendment for the Defense Authorization bill that will be on the floor starting tomorrow which strongly urges repeal of the ban on the military’s insurance coverage for abortion care for pregnancies that are the result of rape or incest in the National Defense Authorization Act for FY2012.

May 27, 2011—AMWA signed onto a letter strongly opposing the House Appropriations Subcommittee on Agriculture 11.5% cutting the FDA’s 2012 FY budget. The agency has been underfunded for years and the cuts will cost the government more than they will save. The result will cost the federal government much more than it saves, because of increased costs of Medicare, VA medical care, medical care for our armed services, Medicaid, and other health care costs. In addition, the delays in getting FDA approval and the recalls that will become necessary because of unsafe food and medicine will cost companies in every state in our nation billions of extra dollars each year. This letter was generated by the National Research Center for Women and Families.

June 2, 2011—AMWA signed onto a letter in support of the District of Columbia’s ability to use its own money as decided by the democratically elected officials of DC, including supporting the provision of abortions for low-income women.

June 2, 2011—AMWA signed onto a letter thanking Senators Inouye and Cochran and Representatives Rogers and Dicks for their leadership in building a health care system that meets the needs of all Americans. Working towards that goal, the Family Planning Coalition respectfully requested that a modest investment be made in the Title X family planning program, with an increase of $10 million in FY 2012 over FY 2010 funding levels. The Title X program is under increasing pressure, as the safety net system aims to serve more patients than ever with fewer resources.

June 10, 2011—AMWA signed onto an amicus brief generated by the National Women’s Law Center a nonprofit legal advocacy organization dedicated to the advancement and protection of women’s legal rights since its founding in 1972. Women have long faced great difficulty obtaining comprehensive, affordable health coverage due to harmful and discriminatory health insurance industry practices. NWLC is profoundly concerned about the impact that the Court’s decision may have on women’s access to health insurance. This brief supports the tenets of the ACA which improve the lives of women and is to be presented in the DC Circuit Court of Appeals (Susan Seven-Sky, et al. v Eric Holder Jr., et al.) in July.

June 22, 2011—As an AMWA representative, Dr. Omega Silva attended a reception held at the headquarters of Planned Parenthood on Vermont Avenue in Washington, DC to honor and welcome the new Representative from New York, Congresswoman Kathy Hochul. She is a champion of women’s health in congress. In her remarks she mentioned the need to keep and strengthen Medicare, to protect reproductive choice, and her sincere thanks to the many women’s groups and organizations which helped to get her elected.

July 3, 2011—AMWA signed onto a statement generated by the National Women’s Law Center to the Centers for Medicare applauding CMS’s attempts to ensure that Medicaid beneficiaries – most of whom are women — have access to critical care. These proposed regulations, as written, take an important first step in addressing access issues. By expanding their reach to managed care organizations, requiring that data be analyzed and reported out by the gender and other characteristics of beneficiaries, the final regulations could be an even stronger way of ensuring access to care. We appreciate the opportunity to comment on the Proposed Rule entitled “Medicaid Program: Methods for Assuring Access to Covered Medicaid Services,” published in the Federal Register on May 6, 2011 (76 Fed. Reg. 26342). The proposed rule would create a process for states to use to evaluate their fee for service Medicaid provider payment rates to determine whether such rates provide “equal access” to services through Medicaid under Section 1902(a)(30)(A) of the Social Security Act (hereinafter Section 30(A)). Issues of access to care are particularly important to women who constitute a majority of Medicaid beneficiaries and those likely to care for beneficiaries.

July 11, 2011—AMWA signed onto a letter generated by the National Women’s Health Network asking HHS to act quickly to extend to contraception the rules prohibiting insurance companies from charging co-payments and other extra fees. HHS is now getting ready to make a decision about this — in the next couple of weeks, the Institute of Medicine will release its recommendations for Women’s Preventive Health Services and after that HHS will be come out with its new policy.

July 11, 2011—AMWA signed onto a letter that Doctors for America drafted to showcase strong physician opposition to cuts in Medicare and Medicaid — particularly the Medicare voucher program and Medicaid block grants.

July 11, 2011—AMWA endorsed efforts to achieve a legislative repeal of the Global Gag Rule supporting efforts underway to ensure that a new Administration cannot reinstate the Global Gag Rule with the stroke of a pen. The Global Democracy Promotion Act will soon be reintroduced in the House of Representatives by longtime champion Rep. Nita Lowey (D-NY) and other original cosponsors. The legislation text will be the same as was introduced in the 111th Congress.

July 23, 2011—AMWA endorsed Congressman Nita Lowey’s (D-NY) bill, the Global Democracy Promotion Act, to be reintroduced July 25, 2011 by Rep. Lowey and the more than 90 original cosponsors garnered ahead of reintroduction. This is a fantastic number of original cosponsors for a bill and a testament to all the hard work of many organizations and the level of support that exists in the House to address this issue!

July 26, 2011—AMWA signed onto a letter supporting a critical campaign that the Global Justice Center (GJC) is coordinating to ensure that women and girls impregnated in armed conflict are provided with comprehensive and non-discriminatory medical care. Foreign governments, NGOs and humanitarian aid providers receiving US funds are prevented from providing the option of abortions to girls and women raped in armed conflict. In honor of the 62nd anniversary of the Geneva Conventions, the GJC is coordinating a letter campaign to President Obama, urging him to issue an executive order lifting these restrictions to humanitarian aid for situations of armed conflict. Where war rape is rampant, this could save the lives of many girls and women. GJC is contacting human rights, women’s rights, reproductive rights, legal advocacy, medical, and humanitarian organizations, as well as members of governments, to join the campaign, with the aim of having letters sent to President Obama on August 12, 2011.

July 28, 2011—AMWA signed onto a letter that The National Health Law Program has prepared urging HHS to adopt all of the recommendations made by the Institute of Medicine (IOM) to expand access to preventive care for women. As was reported on July 20, on that date IOM issued superb recommendations to HHS regarding the preventive services women in Exchanges should receive in their health insurance benefits package. The preventive services that HHS adopts would all be available without cost-sharing, thereby expanding access to critical benefits such as contraception for millions of women.

August 2, 2011—Drs. Omega L. Silva and Eliza J. Taylor attended a reception and educational session on Breast Tomosynthesis, one of the new imaging technologies, sponsored by one of our corporate sponsors, Hologic, today at the JW Marriott in DC. The new technology is like a digital CAT scan of the breast done in 4 seconds along with the regular two dimensional two view mammogram. It allows the radiologist to view different levels of breast tissue and more precisely evaluate and localize lesions. The Newsletter will publish an explanation of the technique.

August 3, 2011—AMWA signed onto a letter generated by the National Research Center for Women and Families to the FDA opposing any efforts by the FDA to loosen the current conflict of interest rules for members of FDA advisory committees. In fact, we believe that the agency’s management of such potential conflicts of interest needs to be made stronger.

September 8, 2011—AMWA signed onto a letter from The Center for Health and Gender Equity inviting members of the National Council of Women’s Organizations to join the Action Council for Women’s Health and Rights, a CHANGE initiative designed to mobilize U.S. groups on women’s health and rights globally. Since 1994, CHANGE has provided critical analysis and advocacy to ensure that U.S. foreign policies and programs promote sexual and reproductive health and rights for women and girls worldwide (www.genderhealth.org). The Action Council will add a chorus of voices to the struggle for women’s health and rights around the world by expanding collaboration across a large group of nonprofit organizations including AMWA.

September 10, 2011—AMWA signed onto a letter generated by the Center for Reproductive Rights questioning the Congressional debates on the FY 2012 budget with respect to policy riders which the signatories from across the progressive community oppose. AMWA joined the previous letter in April to oppose these harmful riders.

October 19, 2011—The National Center for Research for Women and Families is applying to the AHRQ for a grant to study the need to increase consumer and patient acceptance of comparative effectiveness research, which has been renamed Patient Centered Outcomes research in an apparent attempt to sound less frightening (e.g. less like death panels). This research is considered an important part of health care reform. The Center will organize patients, consumer groups and public health workers. AMWA signed on as part of the coalition.

October 19, 2011—AMWA signed onto a letter from the Maternity Care Coalition of Pennsylvania to advocate for the passage of a bill which corrects the notion that pregnancy is a pre-existing condition for insurance purposes.

October 19, 2011—AMWA signed onto a letter to reauthorize the Violence Against Women Program bill now in committee in the Senate under Senator Leahy. It incorporates the Obama administration’s ideas.

October 30, 2011—AMWA endorsed the letter to Congressional appropriators outlining sex education requests for the final Fiscal Year 2012 Labor, Health and Human Services, and Education spending bill. In it we strongly oppose the $85 million cut proposed in the House Chairman’s bill for the Teen Pregnancy Prevention Initiative. We support the President’s budget request to fully fund the initiative at $110 million. We note that the Senate bill maintains current the current funding level of $105 million and request that the program be funded at least at this level. We urge you to continue providing dedicated funding for the Division of Adolescent and School Health (DASH) at the Centers for Disease Control and Prevention as a separate and dedicated funding stream and include $40.2 million for DASH HIV/STD Prevention Education as was proposed in the President’s Budget and supported by the Senate Committee bill. Given the evidence and the ethical concerns, we strongly oppose the resurrection of dedicated discretionary funding for ineffective abstinence-only-until-marriage programs, which is in the House Chairman’s Labor-HHS-Education
Appropriations bill.

December 11, 2011—AMWA endorsed a letter to the Senate and House Leadership and the Appropriations Committee Chairmen and ranking members generated by the National Partnership for Women to delete dangerous riders for the following:
• The elimination of federal funding for preventive and primary care services provided by Planned Parenthood affiliates;
• The elimination of funding for the Title X family planning program;
• The elimination of existing language providing strong evidence standards for teen pregnancy prevention funding;
• The reinstatement of the “Global Gag Rule” on foreign aid;
• A prohibition on contributions to the United Nations Population Fund;
• A ban on local funding of virtually all abortion services in the District of Columbia;
• A ban on insurance coverage of virtually all abortion services for federal employees;
The potential elimination of abortion coverage in plans sold through health insurance exchanges created under the Affordable Care Act;
A broad expansion of current refusal law with potentially significant implications for women’s health.

January 17, 2012—The Research Center for Women and Families/Cancer Prevention and Treatment Fund asked AMWA as part of the Patient, Consumer and Public Health Coalition to sign onto a letter to the FDA on proposed rule changes to reclassify External Pacemaker Pulse Generator Devices. As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices.

January 22, 2012—AMWA signed onto a letter generated by SWHR, American Heart Association/American Stroke Association, and WomenHeart: The National Coalition for Women with Heart Disease which are planning to send to Members of Congress in support of the bill re-introduced in the 112th Congress by Senators Debbie Stabenow (D-MI) and Lisa Murkowski (R-AK) and Congresswoman Lois Capps (D-CA). This legislation seeks to improve the prevention, diagnosis, and treatment of heart disease, the leading killer of American women, as well as stroke and other cardiovascular diseases and the organizations are encouraging them to co-sponsor this legislation.

January 26, 2012—Susan Scanlon, President of the National Council of Women’s Organizations, asked if AMWA could issue a statement regarding President Obama’s decision not to exempt religious organizations from reproductive health coverage. In response to that request AMWA sent the following: The American Medical Women’s Association applauds President Obama’s decision to reject religious exemption on cost-free birth control coverage under the Affordable Care Act. “To prevent unintended pregnancies, all women of reproductive age should have access to safe and effective contraception,” said Dr. Mary Guinan, AMWA President. Cost of contraception has been a major factor in limiting access for uninsured and low income women, and responsible for disproportionately high unintended pregnancy and abortion rates in these woman. Currently, even insured woman are often denied coverage of IUDs and implants, the most effective forms of contraception. With insurance provision of all available methods, American women will have equal access to contraception for the first time in history.

January 30, 2012—The Research Center for Women and Families requested a sign onto a letter to members of Congress advocating for change in the rules for reviewing all devices in the SOUND Devices Ac t of 2012.

February 6, 2012—AMWA signed onto a statement advocating the use of noninvasive measurement of central blood pressure as a more accurate measure of blood pressure.

February 19, 2012—AMWA signed onto a coalition of women’s organizations to protest the fight against the use of birth control and its inclusion in the ACA as preventive services and therefore not subject to additional payments. The Coalition to Protect Women’s Health Care is proposing several activities to demonstrate the displeasure of the 49 organizations which have joined.

February 27, 2012—AMWA signed onto a National Research Center for Women and Families as a member of the Patient, Consumer, and Public Health Coalition to express our concerns about the use of the de novo process for high-risk medical devices to which the FDA will apply to approve an endovascular suturing system “used in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.” AMWA thinks the PMA process should apply to this device.

February 27, 2012—AMWA opposes any amendment restricting a woman’s access to full reproductive healthcare including the Blunt Amendment and have signed a petition signed by many other women’s groups during TRUST WOMEN WEEK expressing such.

February 27, 2012—AMWA signed onto a National Council of Women’s Organizations” Campaign to stop gun violence.

March 5, 2012—AMWA signed onto a letter to Chairman Walberg and Ranking Member Woolsey of the Workforce Protections Subcommittee House Education and the Workforce Committee U.S. House of Representatives in strong support of the rule proposed by the Department of Labor (DOL) to amend the Fair Labor Standards Act (FLSA) regulations to extend basic labor protections to nearly 1.8 million low-wage home care workers. This proposed rule (RIN 1232-AA05) will ensure that these workers are finally entitled to minimum wage and overtime premium pay, correcting a longstanding injustice and advancing economic security and fair pay for women, especially women of color. We oppose any delay in implementing these long-overdue regulations. This letter was proposed by the National Women’s Law Center.
March 15, 2012—AMWA signed onto a letter generated by the National Women’s Law Center for its I Will Not Be Denied Campaign to foster women’s health which includes a video. AMWA’s logo will be part of the program materials. The campaign will start Monday March 19th, 2012 with a press conference on the anniversary of the ACA act’s passing with the video becoming available for the public on March 20th.
April 12, 2012—AMWA signed onto an AMICUS brief on behalf of a mother of four named Juana Villegas who won a civil rights suit against the Metropolitan Government of Nashville and Davidson County after she was shackled during transportation, while in labor, and immediately postpartum despite a “no restraints” order signed by her physician and known to the defendants. Ms. Villegas’ only offense was being an undocumented alien who was arrested for a minor traffic offense. Her punishment was to labor in chains and experience the terror of thinking that her baby would die inside of her because she would be unable to open her legs to give birth, which led to Post Traumatic Stress Disorder. She was not allowed to see her baby or her family. Her infant was taken away from her and without any updates on his condition, or whether she would ever see him again. In jail, although she was suffering painful engorgement, she was denied a breast pump that would allow her to relieve the pressure. For all of this, she was granted a small award of $200,000 by a jury to cover the costs of her future mental health treatment. AMWA has been asked by Ms. Villegas’ attorneys to sign an Amicus Brief organized a group of experts and advocates to bring to the court’s attention the fact that experts in maternal, fetal, and neonatal health and advocates for healthy birth stand opposed to the dangerous and degrading practice of shackling women who pose no safety risk. This effort is being spearheaded by the National Advocates for Pregnant Women.

April 12, 2012—AMWA has signed onto a letter the Patient, Consumer, and Public Health Coalition is writing to comment on the bipartisan HELP committee’s “Incentivizing New Antibiotic Development” discussion draft. The proposals in this may not benefit patients and may harm them. The reason is because the incentives the draft provides will encourage drug companies to develop antibiotics that are not necessarily needed or life-saving, and may promote even more antibiotic resistant toward existing drugs. The Coalition believes that the HELP Committee should give priority to drugs that save lives, not including antifungals which need no incentive for development. The overuse of antibiotics should be addressed and the resulting resistance and the availability of generics in a timely manner.

April 15, 2012—AMWA signed onto testimony to the FDA from the National Research Center for Women and Families in which user fees for devices are discussed. Although the coalition is not enthusiastic about user fees, in today’s budgetary climate, they are necessary, especially since the FDA has been under-funded for years. In particular, the Center for Devices and Radiological Health (CDRH) has struggled to manage an expanded demand for more complex devices with inadequate appropriations. The coalition will continue to advocate with Congress for increased funding for the FDA to ensure the agency has the resources it needs to carry out its mission of protecting and promoting the public health.

April 25, 2012—AMWA signed onto an Amicus Brief generated by the National Advocates for Pregnant Women in the case of S.P in Kentucky who is being denied custody of her child because she used methadone while pregnant and ultimately became enrolled in a drug treatment program where she continued prescribed methadone maintenance until the birth of her child. She remained free of illegal drugs while in the program and became pregnant while in recovery. Methadone is the preferred method of treatment for opiate dependent pregnant women. Unable to enroll in a treatment program because of finances S.P. used a low dose of methadone she obtained unlawfully until she was able to enroll in a methadone maintenance program, which she did before her baby was born. Her daughter was born perfectly healthy with no symptoms or signs of neonatal abstinence syndrome and both mother and daughter tested negative for all unlawful substances at birth. An ill-informed hospital employee, however, reported S.P. to child welfare authorities based solely on the fat that her daughter was “presumptively positive for methadone.”

May 8, 2012—AMWA signed onto an amicus brief generated by the Advocates for Pregnant Women in the case of Juana Villegos who was held in shackles in Nashville/Davidson County after a minor traffic offense as she was an undocumented alien. She delivered in jail in those shackles and was not allowed to feed her baby to relieve the breast engorgement and could not see him at all. The brief is asking for damages due to the shackling and a ruling against such.

May 8, 2012—AMWA signed onto the Pregnant Workers’ Fairness Act being introduced in the House of Representatives This bill would promote nondiscrimination by ensuring that pregnant workers are not forced out of their jobs unnecessarily or denied reasonable job modifications that will allow them to continue working and supporting their families. This request originated for the National Women’s Law Center.

May 13, 2012—AMWA signed onto a letter drafted by the National Task Force to End Sexual and Domestic Violence Against Women opposing the Adams VAWA bill (H.R. 4970) headed to the House floor for a vote next week. We support these tenets of the previous bill to:
• Train over 500,000 law enforcement personnel every year,
• Help advocates to respond to urgent calls for help with the establishment of the National Domestic Violence Hotline that answers 22,000 calls each month,
• Support sexual assault services in every state; when victims receive advocate-assisted services following assaults, rape survivors are 59 percent more likely to have police reports taken than survivors without advocates whose reports are only taken 41 percent of the time, and
• Support programs that reduce domestic violence homicides; as an example, between 1993 and 2007, the rate of intimate partner homicides of females decreased by 35 percent and the rate of intimate partner homicides of males decreased 46 percent.
We all support a strong, bipartisan VAWA reauthorization bill similar to what the Senate passed last month, which would continue the life-saving protections and services needed by victims and their families. Again, H.R. 4970, which recently passed out of the House Judiciary Committee by a near party-line vote, would be a rollback of years of progress and likely increase the number of women and children who could be hurt. H.R. 4970 is genuinely dangerous for immigrant women and their families. It includes damaging provisions that create obstacles for immigrant victims to report crimes, increases danger for immigrant victims by eliminating important confidentiality protections, and undermines effective anti-fraud protections that exist in current law. It expressly rejects protections for men and women who are lesbian, gay, bisexual, or transgender and eliminates strong protections and justice for women and children who are beaten or abused on Tribal lands by perpetrators who are not members of a particular tribe. And it removes a key requirement that would more easily allow victims to move from one subsidized housing program to another in order to avoid an abuser and drops an important provision that would tackle the violence that occurs on our nation’s college campuses.
May 16, 2012—The American Diabetes Association is spearheading a sign on campaign for the Gestational Diabetes Act which was reintroduced in the House and Senate in June 2011 and is bipartisan legislation which seeks to reduce the incidence of gestational diabetes through improved tracking, surveillance, and public health research. Up to 18% of all pregnancies in the U.S. are affected by gestational diabetes. Gestational diabetes carries dangerous health consequences during and after pregnancy, including an increased risk of developing type 2 Diabetes for both mother and child. As AMWA is very supportive of prevention, disease management, and reducing health disparities for women which are issues of concern in gestational diabetes and areas which are covered by this legislation, it will sign on.
May 30, 2012—AMWA is supporting the American Heart Association, the Society for Women’s Health Research, and WomenHeart as the National Coalition for Women with Heart Disease in writing to Congress in support of Section 908 of the Senate’s version of the Food and Drug Administration (FDA) Safety and Innovation Act (S. 3187), which would require the FDA to report on the availability of new drug and device safety and efficacy data by sex, age, and racial and ethnic subgroups. As you work to reconcile differences between the House and Senate legislation, we strongly urge you to include this provision in the final FDA User Fee bill.

May 30, 2012—The Research Center for Women and Families is generating testimony for the FDA for the draft guidance “Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products,” which recommends that industry avoid the use of dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP) as excipients in drug and biologic products. The draft guidance recommends that industry should avoid the use of DBP and DEHP as excipients in drug and biologic products. This recommendation is not strong enough. The FDA should ban the use of DBP and DEHP in excipients especially since “safer alternatives are available.” FDA should also ban the use of these phthalates in packaging materials since DBP and DEHP can leach from the packages into the drug and biologic products. Banning DBP and DEHP will help to reduce the “widespread exposure of the general population to phthalates,” and reduce the real-world, cumulative negative effects of phthalates in the health of children and adults.

June 19, 2012—AMWA signed onto a letter generated by the National Partnership for Women and Families to the Congress to urge support of women’s reproductive health programs in the Fiscal Year 2013 (FY13) appropriations process and rejection of any policy riders and funding cuts that would limit access to critical women’s health services. We are deeply concerned that the appropriations process will once again be used as a tool to restrict women’s health and access to reproductive health care. In this Congress, there have been multiple attempts to use the appropriations process to incrementally chip away at women’s health. For example, the appropriations process has been exploited to prohibit the District of Columbia from using its own locally-raised funds to provide abortion care, to weaken the evidence-based standards for sexuality education that help ensure our young people have access to comprehensive and medically accurate information, and to attempt to create additional barriers to care for rural women by banning abortion providers who use telemedicine from receiving telehealth grants. As a coalition of organizations that care about the health and economic security of women and their families, we strongly oppose any efforts to attack women’s health through the appropriations process.

June 20, 2012—AMWA wrote a letter to urge support of AB 2348 authored by Assembly member Holly Mitchell (D-Los Angeles), which will benefit the women of California by improving access to birth control. AMWA is willing to sign onto this state bill because of its importance as a prelude to action which may be needed in other states. AB 2348 would increase birth control access by authorizing registered nurses in community clinics to dispense birth control under a standardized procedure. Simply put, after taking a routine health assessment, a registered nurse would be able to safely dispense birth control to the more than 90 percent of women who have no complicating factors. For the small percentage of women who have more complex health issues, RNs would refer them to a nurse practitioner or doctor for contraceptive care. AB 2348 would apply to the pill, patch, ring, and depo injection. It would not apply to methods like IUDs or implants that need to be inserted.

June 24, 2012—AMWA signed onto a letter to Representative Markey as a member of the Patient, Consumer and Public Health Coalition, which includes non-profit organizations and individuals that represent patients, consumers, physicians, scientists, and researchers to express our strong support for the Trial and Experimental Studies Transparency (TEST) Act of 2012. This legislation will ensure that patients, consumers and health care providers have better information about the drugs and devices available to them. Representative Markey’s bill would ensure that the transparency goals regarding disclosure of clinical trial information established by the Food and Drug Administration Amendments Act (FDAAA) are fully implemented by closing definitional loopholes and requiring the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to report enforcement actions they have taken against non-compliers. In addition, the bill makes great strides towards transparency in an ethically contentious area by requiring better reporting of study results, rulemaking on registration of foreign clinical studies, and public disclosure of informed consent documents and protocols.

July 3, 2012—AMWA has signed on to be listed as a supporter of the Alzheimer’s Foundation of America’s 10th annual National Memory Screening Day (NMSD) on November 13, 2012. Last year, over 96,500 people participated in NMSD at over 2,540 sites nationwide. This is a 12% growth over the 2010 volume, and is evidence to the growing public awareness of early detection and intervention for memory problems. In addition, AFA is increasingly using NMSD as a jumping off point to start and continue dialogue with Congressional leaders and other policymakers about developing a national dementia screening policy and the importance of early detection, and in late November 2011, AFA convened top experts and government leaders for a one-day symposium on cognitive assessment and is currently drafting a white paper to submit to medical journals.

July 12, 2012—AMWA signed onto an Amicus Brief generated by the American College of Obstetrics and Gynecology and its coalition of organizations of leading Illinois and national medical and public health organizations in the case of parental notification for abortion when the patient is a minor in the state of Illinois. The coalition holds that such notification is not necessary and is harmful to the child and they submit this brief as amici curiae in support of Plaintiffs’ challenge to the Illinois Parental Notice of Abortion Act of 1995 (the “Act”). As leading experts in their fields, amici write to correct the inaccurate and misleading data set forth in the Amicus Curiae Brief of Illinois Legislators, the Amicus Curiae Brief of the Christian Medical and Dental Associations, the American Association of Pro Life Obstetricians and Gynecologists, and the Catholic Medical Association, and the Amicus Curiae Brief State’s Attorneys filed in Support of Defendants-Appellants. As demonstrated and described in the Brief of the Plaintiffs-Appellees, the Act does not further or protect the best interests of minors.

August 8, 2012—As the nation continues to mourn for the victims and survivors of two recent shooting massacres—in Aurora, Colorado on July 20th and Oak Creek, Wisconsin on August 5th—over 90 organizations have joined together to call for stronger gun laws to prevent the next tragedy. The Campaign to Stop Gun Violence is a coalition of national organizations demanding that policy makers enact better laws to keep our communities safe and free from gun violence. AMWA is a member of the coalition.

August 12, 2012—AMWA signed onto a letter generated by the American Congress of Obstetricians & Gynecologists (ACOG) and the American Diabetes Association, in support of bipartisan legislation which seeks to improve the health of women and their babies by investing in the tracking, surveillance, and study of gestational diabetes. The Gestational Diabetes Act (S. 1221 / HR 2194), sponsored by Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) and Representatives Eliot Engel (D-NY) and Michael Burgess (R-TX), seeks to reduce the incidence of gestational diabetes in women and supports prevention programs to improve the health of women and their babies.

August 19, 2012—AMWA signed onto a letter generated by the Government Accountability Project to Members of Congress to ask them to ensure that PHS whistleblowers have the same protections from retaliation now afforded all other employees of the FDA and other public health agencies, a state of affairs that had existed more than 30 years before the courts questioned their eligibility for protection under this statute. PHS workers historically have been under the jurisdiction of the Whistleblower Protection Act, a law which Congress now is working to strengthen and revitalize. Congress should restore to PHS workers the protections they have enjoyed for more than three decades. PHS whistleblowers were responsible for warning that 80% of commercial milk supplies had illegal animal drugs, and caused a testing program that has cleaned up America’s milk supply. They have exposed dangerous, life-threatening practices with vaccines and prescription drugs that saved countless lives. They even saved thousands of pets after revealing that approved veterinary medicines were leading to dangerous and fatal adverse reactions.
August 25,2012—AMWA signed onto the National Center for Research on Women and Families’ statement as a member of the Patient, Consumer, and Public Health Coalition, to express our strong opposition to the Juvenile Products Manufacturers Association’s (JPMA) petition requesting that the US Consumer Product and Safety Commission adopt a rule to distinguish “hazardous pillow-like crib bumpers from “non-hazardous traditional” crib bumpers.[i] The best way to eliminate the very real hazards of crib bumper pads, which include suffocation, is to eliminate the pads entirely. The American Academy of Pediatrics (AAP) has stated that bumper pads should not be used in cribs because they can kill infants and there is no evidence that they prevent injuries.

August 30, 2012—

“In a recent interview, a member of the US Congress, Todd Akin, and candidate for US Senate, suggested that women cannot become pregnant from “legitimate rape”: “If it’s a legitimate rape, the female body has ways to shut that whole thing down.” His stunning comments are repugnant and medically incorrect. Thousands of women in the US become pregnant every year as a result of rape – up to 32,000 women, according to one study. A woman’s body has no magical defenses against pregnancy after forced intercourse. The perpetuation of such blatantly false information is harmful to women, and threatens women’s health.

Further, the egregious reference to “legitimate rape” perpetuates the kind of stigma that adds to the suffering of victims. Any forced intercourse is rape. To claim otherwise is offensive and demeaning, to victims of either gender.

AMWA recognizes that rape is a traumatic and devastating experience, and that the possibility of pregnancy after forced intercourse is very real. AMWA condemns the comments made by the representative. We assert that our elected officials, regardless of political affiliation, have a grave responsibility not to misrepresent medical facts for political purposes.”

AMWA released this statement as a press release.

September 18, 2012—Dr. Omega Silva attended the Tea Dinner at the Indian Embassy in Washington, DC which preceded the scientific symposium at the US Department of Agriculture on the health effects of tea. Along with the Tea Council of the US, the Tea Board of India and some representatives of independent tea companies from India, Dr. Silva enjoyed a wonderful Indian meal and was delighted to become reacquainted with some of the people who had participated in the AMWA afternoon symposium presented by the Tea Council of the US at the GWU a few years ago in which she was the moderator.

September 24, 2012— As a follow-up to the entry on August 25, 2012, AMWA signed on to a letter stating that in the ideal world, parents would understand the risks of crib bumpers and would decide not to use them. However, in the real world, not all parents understand these risks and it is not uncommon for crib bumpers to be given as baby gifts, especially by adults who are not new parents and therefore unaware of the risks. The ASTM standard that claims some bumper pads are less risky will muddle the safety issue even more and give parents a false sense of security. Maryland’s proposed ban on crib bumper pads will help to protect more than 70,000 babies born in the state each year, and that is a bottom line upon which we should all agree.

September 30, 2012—AMWA joined the Amicus Brief being done by the Drug Policy Alliance in the case of Nina Buckhalter to be presented in the Supreme Court of Mississippi. Ms. Buckhalter suffered a stillbirth and is being charged with manslaughter because of alleged drug use during her pregnancy.
A conviction here could create far-reaching bad legal precedent that brands as potential criminals any woman who suffers a lost pregnancy, thus endangering the health and well-being of Mississippi women.
We plan to file an amicus brief on behalf of legal, medical, and public health organizations and experts in opposition to the State of Mississippi’s appeal of an order dismissing Ms. Buckhalter’s indictment for manslaughter. The amicus brief we are drafting will address the following issues, among others:
1. Imposing criminal sanctions on women who continue pregnancies in spite of drug dependency problems contradicts broadly accepted principles of law and is ineffective in halting drug abuse;
2. The prosecution of Ms. Buckhalter is based on medical misinformation and myth rather than peer-reviewed, accurate medical evidence;
3. The prosecution of Ms. Buckhalter endangers public health by jeopardizing the therapeutic relationships between women and their health care providers and deters access to important services; and
4. The overwhelming majority of state courts have concluded that application of homicide laws to reach pregnant women violates legislative intent, undermines public health, and implicates constitutional principles of due process and privacy.
Lindsay LaSalle is the law fellow leading this case.
October 2, 2012—AMWA signed onto a letter to the Members of Congress to request consideration for funding for sex education and that it not be subjected to sequestration. We are committed to supporting sex education programs—the Teen Pregnancy Prevention Initiative (TPPI), the Division of Adolescent School Health (DASH) within the Centers for Disease Control and Prevention (CDC), and the Personal Responsibility Education Program (PREP)—urge you to support a balanced approach to deficit reduction and avoid the devastating damage to these and other critical NDD programs that will otherwise occur as a result of sequestration. The cuts to sex education programs, like the cuts to many other important programs, threaten the health and well-being of our nation’s youth and therefore the future health and well-being of our country. The letter was generated by Sexuality Information and Education Council of the United States (SIECUS).

October 6, 2012—Members of the Patient, Consumer, and Public Health Coalition of which AMWA is a member strongly support the FDA’s proposed rule to require Premarket Approval Application (PMA) for the Class III pre-amendments device Shortwave Diathermy (SWD) for all other uses except for the treatment of malignancies. However, FDA should not allow a Product Development Protocol (PDP) instead of a PMA for this device because PDPs are for devices where a sponsor comes to an “early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.”[i] FDA has stated unequivocally that SWD devices “have not been shown to be safe and effective” [ii] therefore, the devices have no public health benefits, and that also rules out the use of a PDP.

October 6, 2012—Boston, MA – The American Medical Women’s Association (AMWA), advocates for women in medicine for nearly a century, and the American Medical Student Association (AMSA), the oldest and largest independent physician-in-training association in the country, today announced their endorsement and firm support for Death with Dignity, Question 2 on November’s ballot.
Death with Dignity allows terminally-ill patients to have a choice in their health care and provides patients who are suffering comfort and peace of mind,” said Dr. Eliza Lo Chin, President of AMWA. “The AMWA proudly declares our endorsement of Death with Dignity,” she continued.
If passed, Death with Dignity would allow terminally-ill patients to end their pain and suffering through life-ending medication. The Massachusetts question mirrors the law in other states where the terminally ill have had this right for 15 years. Doctor participation in the law is completely voluntary.
“The AMSA understands that quality of life is an important part of health care, as is clearly stated in our organization’s principles,” said AMSA National President, Dr. Elizabeth A. Wiley. “In 1993, we adopted the position of supporting the choice of terminally-ill patients who wish to end their suffering. Death with Dignity encompasses this principle and we thoroughly support it,” she continued.
Ravi Parikh, a student at Harvard Medical School and a member of the AMSA, supports passage of Death with Dignity in Massachusetts. “Patients should be allowed to decide how much suffering they can endure, not their doctor,” said Parikh. “This November, Massachusetts’ voters can vote yes on Question 2 and allow the terminally ill to make this decision,” he continued.

November 5, 2012—AMWA signed onto a letter the National Research Center coalition and the National Women’s Health Network wrote with the Patient, Consumer, and Public Health Coalition to FDA supporting the development and implementation of a unique ID system for medical devices. The FDA’s Center for Device’s and Radiologic Health has released the proposed rule for the new system.

November 7, 2012—AMWA has signed onto an amicus curiae (friend-of-the-court) brief that Drug Policy Alliance will be filing in the Supreme Court of Mississippi in support of Nina Buckhalter. Ms. Buckhalter suffered a stillbirth and is being charged with manslaughter because of alleged drug use during her pregnancy.
We plan to file an amicus brief on behalf of legal, medical, and public health organizations and experts in opposition to the State of Mississippi’s appeal of an order dismissing Ms. Buckhalter’s indictment for manslaughter. The amicus brief we are drafting will address the following issues, among others:
1. Imposing criminal sanctions on women who continue pregnancies in spite of drug dependency problems contradicts broadly accepted principles of law and is ineffective in halting drug abuse;
2. The prosecution of Ms. Buckhalter is based on medical misinformation and myth rather than peer-reviewed, accurate medical evidence;
3. The prosecution of Ms. Buckhalter endangers public health by jeopardizing the therapeutic relationships between women and their health care providers and deters access to important services; and
4. The overwhelming majority of state courts have concluded that application of homicide laws to reach pregnant women violates legislative intent, undermines public health, and implicates constitutional principles of due process and privacy.
November 12, 2012—AMWA, as part of the Patient, Consumer, and Public Health Coalition organized by National Research Center for Women & Families / Cancer Prevention and Treatment Fund, urges the Administration to release the Sunshine Act regulations. Patients need to know if their doctors have received financial incentives from drug and device makers. Public interest groups and members of Congress agree that it is past time to release the regulations and start collecting information on industry payments to healthcare providers. The PPSA regulations (CMS-5060-P, RIN 0938-AR33) are designed to increase accountability and transparency in our health care system. It is not possible to ensure that physicians’ decisions involving prescription drugs and medical devices are based on the best available science, but it is possible to make sure that patients are aware of the financial incentives that their physicians have received from drug and device makers.

December 6, 2012—Diane Helentjaris, MD represented AMWA 12/5/2012 at a meeting convened by the National Women’s Law Center to discuss and organize support for legislation that will be proposed for the upcoming Congress. The Pregnant Workers Fairness Act is to address some of the obstacles facing women in the workplace – specifically, its purpose is to require “reasonable accommodations for issues of pregnancy and childbirth,” requiring employers of 15 or more employees to accommodate known limitations of employees or applicants. Although the ADA and the Pregnancy Discrimination Act provide theoretical protection, these existing laws are being narrowly defined in the courts. As a result, women (ex. in jobs requiring lifting, running, repetitive motion) who could continue to work with some accommodation are facing untoward health effects, forced to take leave, losing their jobs, etc. This bill would help address the courts’ resistance to accommodate pregnancy.

January 8, 2013—AMWA signed onto a new briefing paper “Rights at Risk: The Truth About Prenatal Personhood,” produced by the Center for Reproductive Rights.
http://reproductiverights.org/en/document/personhood-papers-summary-briefing-talking-points.
This package (a briefing paper, executive summary, fact sheet and talking
points) documents the serious legal and policy implications of prenatal
personhood in the US, highlighting the lack of legal basis in US or
international human rights law and using examples of the devastating
consequences that have occurred when these kinds of laws have been adopted
in other countries. We hope these materials can be a resource to advocates
and legislators confronting personhood proposals in their own states. The Texas Chapter is working on trying to build allies in the medical field in Texas, where we
believe we will be fighting a seriously harmful bill banning abortion at
twenty weeks gestation, a bill that if enacted into law will have
significant implications for women experiencing pregnancy complications
after 20 weeks, as well as those seeking abortions, and for any physicians
who routinely treat women later in pregnancy and determine whether there are any local AMWA members willing to get involved in the legislative advocacy we are currently planning.

January 9, 2013—AMWA signed onto a letter from the Patient, Consumer, and Public Health Coalition, strongly opposing recent efforts to delay or repeal the 2.3% excise tax on medical devices. The excise tax was included in the Patient Protection and Affordable Care Act (ACA), so that it would help to pay for benefits such as affordable health insurance for currently uninsured and underinsured Americans. The Affordable Care Act will greatly benefit medical device manufacturers, because more patients and consumers will have coverage that will enable them to afford medical devices. It is necessary for companies that will benefit from the bill to help pay for it. The medical device industry already pays less than its fair share to the FDA or the federal government compared to the pharmaceutical industry.

January 10, 2013—AMWA as part of the coalition formed by the Research Center for Women signed onto a letter to the White House urging the Administration to release the final regulations for the Physician Payments Sunshine Act. The intent of the Sunshine Act, passed in March 2010 as part of the Patient Protection and Affordable Care Act (“Affordable Care Act”) – is to protect patients and to guard the publicly funded Medicare and Medicaid programs from fraud and abuse, which in turn drive up costs for the health care system as a whole. Regulations to implement the Sunshine Act are now 15 months overdue.

January 13, 2013—AMWA as member of the Patient, Consumer, and Public Health Coalition, AMWA recognizes the need for new drugs to reach patients with serious or life-threatening diseases. However, based on our knowledge of existing accelerated approval strategies and the widespread off label use of prescription drugs, we have grave concerns about the creation of a new, vaguely defined pathway intended to approve drugs for limited populations.
There are currently six mechanisms designed to facilitate the expedited development and review of drugs to “address unmet medical need,” some of which are based on extremely small studies. How effective are the existing pathways, and in what way is this new pathway needed or likely to be superior? Moreover, in the PCAST recommendations, from which this proposal was derived, the council understood that such a pathway would be ineffective without overhauling FDA’s approval and regulatory processes to protect patients. No such overhaul is underway.
Until the FDA has persuasively shown that a new pathway is needed and will not foster the development of drugs with unproven benefits that leave vulnerable populations at risk for death and other serious adverse effects, we cannot support this proposal.

February 11, 2013—AMWA signed onto a letter sent to Senator Schumer and Representative McCarthy who are introducing the Fix Guns Check Act. It was generated by the Coalition to Stop Gun Violence’s Campaign to Stop Gun Violence Press Release and sent with the following quote:

“Physicians know first-hand the effects of gun violence on our patients and
their families, whether in the emergency room, surgery or in recovery,” said
Omega Silva, MD, past president and current co-chair of the Advocacy
Committee of the American Medical Women’s Association (AMWA), the vision and
voice of women in medicine since 1915. “Rational discussion on ways to
address the preventable death and injury of nearly 100,000 people in America
every year will benefit the health of all Americans,” added Norma J Waxman,
MD, AMWA’s co-chair of the Advocacy Committee.

February 13, 2013—AMWA signed on to the Coalition for Health Funding which leads the health community in securing increased funding for health agencies and programs, including NIH, CDC, SAMHSA, HRSA, AHRQ, FDA, and the Indian Health Service, among others. Early this year the Coalition convened a Health Summit with leaders of the health agency coalitions to develop a funding recommendation for FY 2014 Function 550. The Health Summit recommends $65 billion for Function 550, a $7 billion increase over CBO’s estimated FY 2013 budget authority level of $58 billion. This request is consistent with the community’s FY 2012 Function 550 recommendation.

March 12, 2013—AMWA signed onto a letter to Senator Tom Harkin, Chair of the HELP Committee of the Senate to support a national standard for sick leave for workers in the Healthy Families Act. Currently, more than 40 million private sector employees (40 percent of the workforce) in the United States do not have paid sick leave. They are faced with a Hobson’s Choice: either go to work ill, or lose pay (and possibly their jobs). Many cannot afford to take an unpaid sick day, and instead will unwillingly spread contagious illnesses when they work. Paid sick leave is essential for one simple reason: employees sometimes become ill or their children become ill, and it is better for everyone if they stay at home rather than go to work or school and infect others with a contagious illness.

March 18, 2013—AMWA signed onto an Amicus Brief generated by the American Congress of Obstetricians and Gynecologists, The American Society for Emergency Contraception, Dr. James Trussell, and Dr. Susan F. Wood who are inviting medical organizations to sign on to our amicus brief being filed in response to several of the lawsuits challenging the federal contraceptive coverage benefit, brought by a for-profit company who wants to deny its employees this important benefit. The case is Grote v. HHS, which is being considered alongside the companion case Korte v. HHS by the Seventh Circuit Court of Appeals. We also hope to file this brief in other circuit court cases, including the Autocam v. HHS case in the Sixth Circuit Court of Appeals.
March 18, 2013—Dr. Omega Silva attended a conference on Comparative Effectiveness Research organized by the National Research Center for Women and Families and the Consumer Reports and held at the Pew Center, Washington, DC. This conference actively engaged patient, consumer, and public health leaders. National polls show that many people associate comparative effectiveness research with death panels and rationing of care. They think that such research will tie the hands of their physicians, who they assume are providing the best treatment available. Experts from across the country shared information about the benefits and pitfalls of comparative effectiveness research and patient-centered outcomes research, and how it can be used to improve medical care while preserving essential treatment options.

March 26, 2013—AMWA signed onto a letter generated by the National Research Center for Women and Families as stakeholders in the programs of the Departments of Labor, Health and Human Services (HHS), and Education—to urge the Committee on Appropriations of the Senate to provide the largest possible FY 2014 302(b) allocation to the Labor, HHS, Education and Related Agencies Appropriations Subcommittee. Rebuilding our investment in these domestic programs will boost the economy and reduce the deficit through prevention of costly chronic diseases, increased earnings, and reduced expenditures for unemployment and other social service programs.

March 28, 2013—The South Florida chapter of the American Medical Women’s Association (AMWA) wrote the Florida House Chairman Robertson in support of his proposed legislation, HB 735 (&SB 808), to legalize syringe exchange programs in the state of Florida. Sharing contaminated injection equipment is one of the primary causes of the continued spread of HIV and is the number one cause of hepatitis C transmission. It is time for Florida to join with the thirty-five other states that have established these programs and protected injection drug users and their partners from infection, saved public health costs, and reduced the number of improperly discarded syringes in public places. This bill would significantly impact the health of women and children in the state, who are the unintended victims of IVDA who become infected with HIV. Women are more likely to become HIV positive through sexual exposure. Once infected, women have the potential to spread the virus during pregnancy therefore infecting not one but two lives. We encourage you to schedule hearings for HB 735, and allow the public to look closely at the need for and benefits of such services.

March 28, 2013—AMWA signed onto a letter generated by the Research Center for Women and Families to key Senators in favor of not repealing the excise tax on medical devices. This nonbinding amendment to the Budget bill would provide momentum for subsequent efforts in the House and Senate. The result: the Affordable Care Act would lose $29 billion over the next decade – money that is needed to subsidize health insurance for low income individuals and families.

April 12, 2013—AMWA signed onto an Amicus brief being prepared by Robert Chang and Anjana Malhotra of the Seattle School of Law to the U.S. Supreme Court in a case involving racial discrimination and retaliation in an academic medical environment. The brief raises the serious problems of discrimination and retaliation against women and minorities in the medical profession, and the resulting adverse consequences for the medical profession and public health.

The amicus brief is being filed by a coalition of medical organizations in support of a Middle Eastern clinical professor who was fired in retaliation for complaining about pervasive discriminatory he faced by his supervisor. A jury found that his employer violated his rights under Title VII of the Civil Rights Act and awarded him $3.6 million. Though the decision was largely upheld by the U.S. Court of Appeals, the Supreme Court agreed to review his case.

In the brief, a coalition of medical organizations argues that an adverse ruling against the physician would diminish important protections that exist to protect employees against retaliation. The brief argues that this, in turn, would have serious negative consequences to women and minorities in academic medicine.

April 29, 2013—AMWA signed onto a letter a student proposed that was submitted as a non-partisan public health bill (HB735/SB808) which will allow for needle exchange programs in Florida to reduce the amount of contaminated needles off the streets and parks, prevent accidental needle sticks from first responders and law enforcement, and reduce the transmission of blood borne disease like HIV and hepatitis. Available data shows that these programs are cost effective, do NOT increase drug use and both reduce transmission of disease and encourage people to seek treatment. The bill will also overall reduce the amount of state taxpayer costs by decreasing costs associated with new HIV cases who would otherwise receive treatment through public sector programs like Medicaid, Medicare or Ryan White.

April 29, 2013—AMWA signed onto a letter to express dismay at the dismantling of the requirements for teaching of women’s reproductive health and the paucity of reproductive health procedures being required for competency by family medicine graduating residents. We understand that removing specifics can be helpful by giving more room for innovation and reducing the complexity of reaccreditation. On the other hand, we need to balance the educational and workforce needs for the role of family physicians as first-line caregivers to women of reproductive age. Family planning clinics are closing and merging with other facilities. Community health centers and residency clinics, where family physicians tend to work, are in the process of doubling in capacity due to Affordable Care Act increases in funding. These sites are the new front lines of family planning care. This letter was prepared in response to requests from the ACGME for comments. We wrote to encourage the organization to retain the requirement that family medicine residents learn contraception and options of counseling for unintended pregnancy and that the procedures list be expanded to include IUDs, implants and uterine aspiration.

May 6, 2013—As a member of the Patient, Consumer, and Public Health Coalition, AMWA welcomes the opportunity to provide views on the Senate Health Committee’s draft proposal on pharmaceutical compounding. The Coalition is very concerned that the draft does not adequately address the public health threats posed by compounding pharmacies and will not do enough to prevent future health care crises. Although it might reduce the likelihood of the deaths from products made by companies such as NECC, it will do little to protect the health and safety of thousands of patients who are unwitting customers of large compounding pharmacies that sell defective oral drugs to treat cancer or other life-threatening diseases, or that sell large quantities of sterile products within a state. The Coalition’s letter made specific suggestions.
May 6, 2013—AMWA signed onto support a similar bill as above from the House which does address a more extensive tracking system for pharmaceutical drugs. The letter to the House committee was sponsored by the Pew Charitable Trust to the HELP committee on the Drug Store Supply Chain Security Act.
May 20, 2013—AMWA signed onto the Lung Cancer Mortality Reduction Act, a major part of which was adopted into law last year as part of the Recalcitrant Cancer Act. There is still much work ahead in the fight against the leading cancer killer of women. Most of the energy right now is focused on the responsible and equitable deployment of lung cancer screening nationally. There are some barriers because of the role of the US Preventive Services Task Force in approving coverage for screenings pursuant to the Affordable Care Act. This letter was sponsored by the Lung Cancer Alliance.
July 15, 2013—AMWA as part of the coalition organized by National Research Center for Women and Families has signed onto its letter of comments requested by the FDA in that the FDA has been flooded with industry comments advocating that the already loose rules regarding modifications to medical devices be weakened even more. The Institute of Medicine has stated that 510(k) cleared devices are not proven safe or effective, and a half billion 510(k) devices were recalled as high-risk in a 12 month period ending in January 2011. The last paragraph of the letter is included here: The FDA’s core mission is to protect the public’s health not to expedite changes—without reviewing them—to medical devices. It should be the FDA not industry that decides whether a modification to a device requires a new 510(k) application. We oppose using risk management, design controls, critical specifications, and risk-based stratification in deciding when a new 510(k) is required. However, if FDA continues to allow devices to be modified without a new 510(k) application, then we support periodic reporting as long as funds from user fees pay for the FDA’s staff time to review the reports, and that FDA has the authority to issue sanctions to manufacturers who inappropriately modified a device.

August 22, 2013—AMWA as part of the National Research Center for Women and Families Coalition for Patient, Consumer, and Public Health signed onto a letter to the FDA concerning cardiac devices and their approval specifically the reclassification of external counter-pulsating devices for treatment of chronic stable angina and the
effective date of requirement for premarket approval for external counter-pulsating devices for other specified intended uses. Since high-risk devices are considered Class III, we see no justification for down-classifying this obviously high-risk device used for the high-risk indication of chronic stable angina, and all other indications. We believe that high-risk cardiac devices should remain Class III devices and be subjected to pre-market approval (PMA) because they are life-supporting and life-sustaining. When they aren’t held to the higher standards of PMA, we lose 4 important safeguards:
1. Proof of safety and efficacy based on short-term clinical trials
2. FDA’s authority to require post-market, long-term clinical trial safety data as a condition of approval
3. FDA’s authority to inspect the manufacturing facility prior to approval
4. FDA authority to rescind approval if the device is later found to be unsafe

September 9, 2013—AMWA signed onto a letter as members of the Patient, Consumer, and Public Health Coalition to the FDA opposing the order that will reclassify stair-climbing wheelchairs (a preamendment Class III device, indicating high risk) into Class II (moderate risk). Stair-climbing wheelchairs can provide better mobility to patients than standard wheelchairs but FDA needs to assure that the stair-climbing wheelchairs are as safe as possible. To do so requires them to be correctly categorized as the high risk devices that they are (class III) and be reviewed through the more rigorous PMA process.
September 9, 2013— AMWA as a members of the Patient, Consumer, and Public Health Coalition, is writing to express its strong support for the FDA’s efforts to improve how it communicates information on medical products to all Americans, and especially underrepresented subpopulations. However, the plans as outlined in the report are not specific enough to provide meaningful information about how these efforts will be implemented. The devil is in the details, and there are very few details in this FDA report. The report does, however, provide several examples of the FDA communications in “plain language” which we feel are not sufficient to provide communication to the public.
September 16, 2013—AMWA signed onto Comments of Members of the Patient, Consumer, and Public Health Coalition on Proposed Order “Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses” [Docket No. FDA-2013-N-0581] As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA’ s proposed order for Intra-Aortic Balloon and Control Systems (IABP) devices used to treat septic shock or pulsatile flow generation (Other Specific Intended Uses) to remain in Class III with Premarket Approval applications (PMA) required. The evidence of safety and effectiveness for these indications has not been established. As the FDA noted in its assessment of the device, there is no “theoretical or demonstrated benefit to using the intra-aortic balloon and control systems for this clinical syndrome.”
September 23, 2013—AMWA signed onto the coalition letter of the National Research Center for Women and Families to FDA Commissioner Hamburg supporting FDA’s ban on Ranbaxy medical products. Millions of Americans rely on generic drugs and they need to know that these drugs are truly equivalent to brand name drugs. The company’s facility is not complying with current good manufacturing practices (cGMP), which are the main regulatory safeguard to ensure drug manufacturing quality. As you know, the doctors’ and public’s trust in generic drugs makes it possible to save billions of dollars in health care costs while providing excellent medications. If their trust is eroded, healthcare costs would skyrocket. For that reason, it is essential that the FDA remain firm in its regulation of Ranbaxy and other generic manufacturers.
September 25, 2013—As a member of the Patient, Consumer, and Public Health Coalition of the National Research Center for Women and Families, AMWA strongly supports the Patient Protection and Affordable Care Act (ACA) and opposes efforts to undermine this essential program that will benefit millions of Americans. In the upcoming negotiations over the budget and debt ceiling, AMWA urges you to reject the repeal of the 2.3% excise tax on medical devices. AMWA supports the excise tax as one of several new levies included in the ACA to help pay for affordable health insurance. The ACA will greatly benefit medical device manufacturers, because more patients and consumers will have coverage that will enable them to afford medical devices, such as screening tests, antiseptic wipes, ultrasound, mammography, cardiac devices, and hip implants. Like the other levies in the ACA, the device tax was designed to ensure that the companies that will benefit from the ACA will do their part to help support it.
September 25, 2013—AMWA along with other organizations wrote to applaud the Food and Drug Administration (FDA) on making the decision to revise to the FDA’s drug labeling regulations to enable manufacturers of generic drugs to update patient safety labeling in appropriate circumstances. We believe that it is critically important all prescription drugs, including generic drugs, carry current and suitable safety warnings and allowing generic drug manufacturers to update patient safety labeling is vital to ensuring that the public is appropriately informed of their risks and benefits. Moreover, making this revision to the drug labeling regulations will ensure consumers who are injured by generic drugs have the same legal rights as those who are injured by the brand name versions of the same drugs. Both brand name and generic manufacturers should have the ability, and the obligation to give consumers the information they need to avoid injuries.
September 29, 2013—AMWA signed onto a very general letter of support generated by the Pew Charitable Trust addressed to HELP and Energy and Commerce leadership, which urges passage of the Drug Quality & Security Act. This bill contains important provisions to protect consumers and patients. It creates a strong national unit-level serialization and traceability standard to keep unsafe medicines from reaching consumers. The bill is also a step forward in the longstanding effort to reduce the risks of drugs made by compounding pharmacies. It restores key provisions of section 503A of the Food, Drug, and Cosmetic Act and creates a “voluntary category” of outsourcing facilities that will enable hospitals and clinics to purchase drugs made under higher quality standards.

October 17, 2013—AMWA endorsed the Clinical Practice Guidelines generated by Compassion and Choices for Aid in Dying and drafted a statement that “AMWA endorses these clinical guidelines to assist physicians who practice in states which have the opportunity to aid patients dying.”

October 21, 2013—AMWA signed onto the thank you letter to The Honorable Harry Reid generated by the members of the Patient, Consumer, and Public Health Coalition thanking him for his strong leadership in passing a clean Continuing Resolution, which reopened the federal government and avoided a worldwide financial disaster. We especially want to thank you for holding firm on retaining an important funding source for the Affordable Care Act, the 2.3% excise tax on medical devices.
The excise tax went into effect in January, and device companies are doing very well this year. Despite the tax, a survey of more than 3,500 medical device companies this year found that 71% are optimistic about their own companies’ outlook in 2013, which is even higher than they were in 2012. In a different survey, almost half the medical device manufacturing companies expected an increase of their workforce in 2013. A recent analysis noted that the prices of devices in the U.S. far exceed the prices for the same devices sold in other countries, with the top five devices costing approximately twice as much in the U.S. as other comparable countries.”
October 22, 2013— AMWA joined the National Women’s Law Center, the National Partnership for Women and Families, the American Civil Liberties Union, A Better Balance, Legal Momentum, Equal Rights Advocates, the Legal Aid Society—Employment Law Center, and Physicians for Reproductive Health to celebrate the Pregnancy Discrimination Act (PDA) as it turns 35! The best way to celebrate is to move the Pregnant Workers Fairness Act (PWFA), a bill that builds on the PDA’s legacy to ensure fair treatment for pregnant workers to being law. Too many pregnant workers are still being forced to choose between protecting their pregnancies and keeping their jobs. PWFA would make unmistakably clear that employers must make the same types of reasonable accommodations for pregnancy, childbirth, and related medical conditions that they do for disabilities.
November 7, 2013—AMWA signed onto a letter from a group of health organizations to support the Physicians Sunshine Act that would include medical text books and reprints as well as free meals and other items as items to report because consumers need to know.
November 19, 2013—AMWA signed onto the letter from the coalition which includes organization and we are writing to offer comments on the Food and Drug Administration’s (FDA) recent report, Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products. Our organizations believe it is critically important that data about how new drugs and devices work in women, minorities, and older Americans be publicly available to patients, clinicians, and researchers on a consistent and reliable basis. The FDA’s report reveals that, although progress has been made in the last two decades, there are still gaps in the participation of women, minorities, and the elderly in clinical trials, the analysis of subgroup differences, and the availability of subgroup-specific data to clinicians, researchers, and patients. These shortfalls are particularly evident with respect to minority participation and in device trials. We believe that if the Action Plan that FDA is required to issue by July 2014 includes our specific recommendations and enforcement, these gaps can be narrowed; important subgroup-specific data will be more widely and consistently available to the public. This letter was promulgated by the American Heart Association and the American Stroke Association.

December 4, 2013—Diane Helentjaris, MD, MPH participated in a conference call on AMWA’s behalf on December 3, 2013 meeting of stakeholders and the FDA concerning the new Drug Quality and Security Act signed November 27 by President Obama. Most of the attendees seemed to be from the pharmaceutical industry and there were many questions. The law sets up a 10 year phase-in for implementation of a “track and trace” system for some manufactured drugs. The goal is to secure the system against counterfeit, stolen, unapproved, or recalled drugs as well as to increase the efficiency of drug recalls. Manufacturers will be required to place a unique identifier on certain prescription drugs. Starting January 2015 there will be new requirements for various entities, especially pharmacies, to provide track and trace capability, communicate problems, respond and investigate, control and stop issues. The goal is interoperability and there will be pilot projects as part of the implementation. Dr. Helentjaris asked what studies or fiscal impact analyses had been done as to the potential for either cost savings or increased drug costs; the speaker has “no information” about that but assumed that the burden would be eased by the long implementation time. How far forward the tracking will go was not answered; many drugs included chemicals manufactured in overseas companies such as in China and India. In general, there was a lot of discussion about the desire for stakeholder input. It seems that much is still to be settled. In looking over news coverage of this Act, the press portrayed it as a response to the fiasco with the compounding company in Massachusetts – now all the compounders will be “encouraged” to register with the FDA and hospitals and docs will be encouraged to do business only with registered entities. However, the teleconference staff seemed to take a much broader view.
January 22, 2014—AMWA signed onto The National Research Center for Women and Families’ Coalition letter on the changes the FDA is proposing for Generic Labeling in” Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985)”. The new regulations will improve the health of all Americans by providing the most current information about the risks and benefits of drugs. Also, the proposed rule would allow patients to seek legal redress, if they are harmed by inadequately labeled generic drugs. The proposed rule provides a clear framework to ensure that both the reference listed drug (RLD) and the abbreviated new drug application (ANDA) drug return to labeling uniformity in a timely manner. We strongly support the requirement that all manufacturers of a drug update their labels with new safety information within 30 days of FDA approving the labeling change. In addition to the specific provisions of the rule, legal accountability is a powerful incentive for generic drug manufacturers to take post-market monitoring more seriously. We strongly urge the FDA to adopt the proposed rule in its current form, and to do so as soon as possible.
January 22, 2014—AMWA has signed onto a letter from the American College of Radiology to the CMS. On November 6, the Centers for Medicare and Medicaid Services (CMS) posted an FAQ on the CMS web site stating that breast tomosynthesis should be reported using one of the full-field digital mammography codes G0202, G0204 and G0206. The ACR disagrees with this coding recommendation and is in the process of requesting that CMS revise its coding guideline. The digital mammography codes do not accurately describe the procedure performed or take into consideration the additional work and associated practice expense involved with breast tomosynthesis. Therefore, the ACR maintains its current recommendation of reporting an unlisted procedure code to describe digital breast tomosynthesis while this is being discussed with CMS.

February 11, 2014—AMWA signed onto the NRC’s coalition letter about antibiotic resistance as AMWA did not agree fully with the ADAPT ACT version but agreed more with CDC version. We strongly agree with the CDC that “Perhaps the single most important action needed to greatly slow down the development and spread of antibiotic resistant infections is to change the way antibiotics are used.” The CDC points out that “as much as 50% of the time, antibiotics are prescribed when they are not needed or they are misused.” The ADAPT Act must be improved. If antibiotics are speedily approved but are not safe or effective, then we have caused more harm than good to patients. AMWA supports the Slaughter proposal which is HR 1150. The many antibiotics routinely fed to farm animals are most often used to spur growth rather than to fight infections. The Centers for Disease Control and Prevention’s (CDC) recent report explains that the overuse of antibiotics for animals helps to spread antibiotic resistance, because “drug-resistant bacteria can remain on meat from animals” and “the bacteria can spread to humans.” In 2011, “80% of antibiotics sold by weight in the U.S. were used for meat and poultry production.” Although the FDA recently issued a voluntary guidance on the use of antibiotics for animals, it has been sharply criticized as being weak and ineffective. H.R. 1150 would phase out the routine use of eight classes of medically important antibiotics in farm animals while still allowing the treatment of sick animals. We strongly agree with the National Academy of Sciences that “substantial efforts must be made to decrease inappropriate overuse [of antimicrobials] in animals and agriculture.” That is why we strongly support H.R. 1150, which will reduce antimicrobial resistance by reducing or eliminating the use of these drugs in healthy farm animals. We received a thank you letter from Rep. Louise Slaughter.
February12, 2014—AMWA, as a member of the NRC’s Patient, Consumer, and Public Health Coalition, strongly opposes the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014. The Act, as drafted, would have the harmful consequence of exempting so-called “health software” and “clinical software” devices from FDA oversight. Also, the Act is premature. Congress is awaiting a study commissioned in 2012 to guide policymakers on this very issue.

Health care providers and patients rely on the FDA to establish that a device is reasonably safe and effective. Without FDA to carefully scrutinize the risks and benefits of a device, patients’ health may be seriously harmed. Even if the device itself is not harmful, if it is not proven effective, then patients could be harmed by inaccurate results that are either anxiety-producing or erroneously reassuring; either could result in unnecessary testing or serious illness or death.
We are extremely concerned that this bill will deregulate a broad swath of medical devices that rely on software and will create opportunities for rampant “gaming” to avoid regulation. For example, MRIs and CT scanners, or heart monitoring devices, might no longer be regulated by the FDA. This would put millions of Americans’ health unnecessarily at risk.

March 11, 2014—AMWA joined some of the nation’s leading women’s health and civil rights organizations to collectively support Medicare coverage for lung cancer screening. We do so on behalf of the tens of thousands of women each year who are diagnosed with lung cancer, most of whom will die from it. While we celebrate the progress that has been made with breast cancer and most gynecological cancers, we are deeply committed to seeing similar progress for women with lung cancer. Lung cancer’s lethality is directly linked to its late stage of diagnosis. Like other stealth cancers – including ovarian – lung cancer is generally not symptomatic until it has already spread. There is no cure for advanced stage lung cancer. That is why early detection is so critical. Just as mammography changed the trajectory of breast cancer, lung cancer screening will change the trajectory for lung cancer by allowing it to be detected and diagnosed at earlier, more treatable stages. For this reason, we urge the Centers for Medicare and Medicaid Services (CMS) to approve Medicare coverage of lung cancer screening for those members of the Medicare population included in the United States Preventive Services Task Force (USPSTF) recommendation. This recommendation, issued on December 31, 2013, awarded a B grade to annual screening of adults between 55 and 80 years of age who are either current heavy smokers or former heavy smokers who quit within the past 15 years. Over half of new lung cancer cases are being diagnosed in people who have already quit smoking. The strength of the evidence in support of lung cancer screening for the Medicare population is substantial. And if CMS also considers the fact that the median age at diagnosis for lung cancer is 70, it seems indisputable to us that Medicare coverage of lung cancer screening is both necessary and appropriate.

March 11, 2014—AMWA is pleased to support the Health Equity and Access under the Law (HEAL) for Immigrant Women and Families Act of 2014.
Almost two decades ago, politicians began enacting harmful restrictions that put affordable health coverage out of reach for many immigrants authorized to live and work in the United States. The HEAL Immigrant Women & Families Act would remove political interference so immigrants can participate in the health care programs their tax dollars support. By restoring access to coverage and allowing immigrants to receive the health care—including sexual, reproductive and maternal services—they need, this bill will help build healthier communities and a stronger economy.
March 24, 2014—This is a Non-endorsement:
This is the original request to Dr. Tousimis and Dr. Chin :
The American College of Radiology (ACR) Breast Imaging Commission and the Society of Breast Imaging (SBI) would ask that the American Medical Women’s Association consider joining ACR, SBI and others in signing the attached letter to the New England Journal of Medicine calling for the withdrawal of a paper published at the end of 2012 by Dr. Bleyer and Dr. Welch entitled “Effect of Three Decades of Screening Mammography on Breast-Cancer Incidence” (N Engl J Med 2012 :1999-2005.). The Bleyer and Welch paper is having a major negative impact on the discussion about, and even access to, breast cancer screening. It was actually cited by the Swiss government as a primary reason that they have opted against regular screening of women.
In that paper the authors claimed massive overdiagnosis of breast cancer by mammography. A subsequent paper by Dr. Daniel Kopans (Arguments Against Mammography Screening Continue to be Based on Faulty Science. The Oncologist 2014;19:107–112), from the Massachusetts General Hospital and Harvard Medical School demonstrates the fact that the Bleyer and Welch paper was based completely on estimates, and Dr. Kopans argues that the estimates they used are likely incorrect. Papers based on direct patient data show little if any overdiagnosis of invasive breast cancer.
The diagnosis and management of Ductal Carcinoma in Situ, as everyone knows, is a legitimate area for discussion, but the data clearly show that the death rate from breast cancer declines when invasive cancers are treated at a smaller size and earlier stage. In his rebuttal (Bleyer A. Were Our Estimates of Overdiagnosis With Mammography Screening in the United States “Based on Faulty Science”? The Oncologist 2014;19:113–126) to Dr. Kopans, Dr. Bleyer admits that their paper actually cannot fault mammography since they did not use direct patient data and did not have any information on who actually had mammograms. Dr. Bleyer also admits that their analysis was based on “best guesses”.
We believe that medical recommendations should be based on science and not “best guesses”, especially when those “guesses” are incorrect. If you agree, please sign the accompanying letter along with your address and professional affiliation and return it via this email.

This is my request for endorsement or non-endorsement:
Dear All:

There is a lot of controversy and debate about the use and non-use of mammography and other forms of radiologic diagnosis and the treatment of breast cancer. I think in the end the pathway each woman takes depends on her attitude and knowledge and her doctor’s beliefs. I personally had to make a decision about breast cancer based initially on the mammogram and then on biopsies and lastly on sentinel node biopsy. I have a lot of respect for the editors and the editorial committee of the NEJM. I have been published in that journal. For a group to ask that a paper be withdrawn is a very harsh highly debatable move to take. When is the last time you have seen a paper withdrawn at the request of a third party–not the author or the editors of the journal. I only know of papers based on fraudulent data being withdrawn. Using estimates is not fraudulent if it is clearly stated which must have been the case here. I absolutely would not on my signature get AMWA involved in such a controversy. So I say ‘NO”.

I do think there is another way to express an opinion which still has to be written by someone who is willing to research the topic and speak to all the pros and cons. That way could be a letter to the editor, in which case the authors would get a chance to rebut your arguments. Even the bibliography would be daunting–probably about a hundred articles. Who is willing to do that? Also, I think many healthcare practitioners would immediately believe that a withdrawal request coming from radiologists and breast cancer oncologists would have a bit of conflict of interest in this controversy.
Omega C. Logan Silva, MD, MACP

These are the responses: I agree with Omega’s comments. This is not our battle. We can instead focus on our position to disseminate information about prevention of disease, screening guidelines and new advances in disease management. As an Internist, each patient I see is stratified based on their individual risk and my clinical suspicion. While the guidelines give general recommendations, my approach with each patient is individualized as Omega described. This will open a Pandora’ s box if we sign our name to it and will break many bridges that we have worked hard to create.
Farzanna S. Haffizulla, MD FACP

I will read the original papers and then respond.
My gut at this point is to hold off putting Amwa’s name on the letter.
This is a highly controversial area. it is completely appropriate for Eleni to put her name on as Amwa past president.
Will try to review and respond soon

Norma Jo Waxman MD
Her response was not to endorse.

I asked for an opinion from the President of the National Research Center for Women and Families, Diana Zuckerman who is quoted in the media often and this was her answer:
Omega,
I agree with you completely. Asking for an article to be withdrawn is inappropriate unless it is fraudulent or so flawed as to be indefensible.
Our Center is in the process of reviewing all our previous online articles on mammography and the new ones, and will be putting our findings on our web site soon. I don’t know exactly what we will conclude, but it is important to emphasize that the NEJM article is not unique in its findings. The Cochrane Collaborative has been saying mammograms do more harm than good for more than a decade. We haven’t agreed with their conclusions in the past, but that doesn’t mean that their findings are not worthy of publication and debate.
Also, the devil is in the details. The results vary depending on whether the question is mammography annually starting at age 40 for all women, or every other year starting at age 50 for average-risk women. ACR has taken the position that mammograms should be annually starting at 40 for all women), despite the findings of the US Preventive Services Task Force, and others, that this results in overtreatment of false positives as well as higher than necessary exposure to radiation that can increase the risk of cancer,
In our view, a shortcoming of frequent mammography starting at 40 is the tendency to overtreat every abnormality, and this is likely to increase because digital and 3D mammograms find more abnormalities. That is a problem of the doctors and patients (who are terrified of breast cancer), not of mammography itself. But with so many women getting bilateral mastectomies for DCIS, one can’t ignore the overtreatment problem. Similarly, the advantage of earlier detection by mammography is lost if women with DCIS or Stage 1 get the same treatment as the women with Stage 2 or 3.

March 27, 2014—AMWA has signed onto a letter generated by the National Women’s Health Network to the FDA asking that Flibanserin, a drug developed to treat sexual dysfunction in women not be approved for that purpose as it is not effective.
In that letter the coalition is writing to support the FDA’s evidence-based evaluation and decision-making with regard to flibanserin and its continued strong stand that a drug cannot be approved when the minimal benefit does not outweigh the risks. We would also like to convey our concern regarding recent statements questioning the FDA’s standards for sexual dysfunction drugs for women versus those for men. The recent second rejection of flibanserin generated questions and concerns about gender equity at the FDA; specifically, whether the agency is holding drugs for women to a different standard that those for men. We believe these concerns are based on misunderstanding and misrepresent the reasons for the recent rejection of flibanserin and the agency’s judicious request for additional safety information. It is not only reasonable, but vitally important for organizations advocating on behalf of women’s health to press on all fronts for women to have both the information and the resources needed to achieve satisfactory sexual lives. However, women also rely on the FDA to ensure that any drugs or devices that we use for this purpose are both safe and effective. The problem with flibanserin is not gender bias at the FDA but the drug itself. The FDA wisely rejected flibanserin in 2010 because it failed to meet effectiveness standards and because the initial sponsor, Boehringer-Ingelheim, had inappropriately changed clinical trial methods midstream. In 2013, the FDA again did not approve flibanserin – now sponsored by Sprout Pharmaceuticals – because the minimal benefits in increasing women’s sexual satisfaction were offset by a worrisome side effects profile and unknown long-term effects. The benefits did not outweigh the risks. Because several drugs have been approved for male sexual dysfunction, groups have asked whether the FDA is holding women’s sexual satisfaction to a different standard. A recent blog titled “The FDA, Sexual Dysfunction and Gender Inequality” inaccurately claimed that there are 24 drugs approved for men, and zero for women. However, this claim perpetuates a miscalculation. It counts each brand name drug and its identical generic counterparts or different formulations as unique treatment options, which artificially inflates the number of drugs available for men. In fact, there are only six different FDA-approved drugs available for male sexual dysfunction, including erectile dysfunction. Nevertheless, the inflammatory claim of gender bias produced press and political attention. More to the point, however, the gender equity argument ignores the real safety difference between flibanserin and the drugs approved for men: a different indication for use, specifically the dosage and administration. The drugs approved for men are all taken on an as-needed basis, whereas flibanserin, a central nervous system serotonergic agent with effects on adrenaline and dopamine in the brain, requires chronic — daily, long-term — administration. This is a more dangerous toxicology situation and it is an appropriate reason that approval of flibanserin requires elevated safety scrutiny. Substantial adverse events reports and drop-out rates in the trials rightly required serious consideration. Last but certainly not least is a new problem with flibanserin’s application and proposed indication for use that must be considered – recent changes in official sexual dysfunction nosology. Hypoactive sexual desire disorder is no longer listed in the DSM-5 (5th edition approved by the American Psychiatric Association in May 2013). Flibanserin, as currently tested, would be approved for a nonexistent condition that will no longer be diagnosed. Rigorous DSM-5 processes were unable to support a distinction between sexual desire and arousal disorders for women, and the new terminology, “female sexual interest/arousal disorder,” offers revised criteria for making a diagnosis. As patient, consumer and women’s health organizations long engaged with the FDA, we support the agency’s concern for drug safety shown in its handling of the flibanserin applications and look forward to its continuing concern and support for women’s health and safety.

AMWA also signed onto a letter from the coalition the NRC formed agreeing with the FDA’s above decision, but asking that other drugs which were approved without efficacy, but with harmful side effects be deemed unapproved in the future. We want the FDA to reject drugs that are harmful, but have many existing alternatives such as:
• Brisdelle (a low dose of the antidepressant Paxil) was approved for hot flashes even though the women taking it in randomized clinical trials had similar numbers and severity of hot flashes to women taking placebo. But, Brisdelle increased the risk of suicide dramatically compared to placebo among women who were not depressed prior to taking the drug.
• Farxiga was approved for diabetes, although the patients taking it in randomized clinical trials were 5 times as likely to be diagnosed with bladder cancer, twice as likely to be diagnosed with breast cancer, and had increased risk of renal failure. It lowered blood sugar, comparable to other diabetes drugs, but actual health benefits were questionable. In clinical trials for Farxiga, less than 4% of patients were African-Americans, a group with the highest diabetes rate in the country.
• Sirturo (bedaquiline) was approved for multidrug-resistant tuberculosis even though patients taking it with the standard drug regimen were 5 times more likely to die than patients who only took the standard drug regimen.
AMWA signed onto the NRC’s letter described above.
April 11, 2014—As a member of the Patient, Consumer, and Public Health Coalition, AMWA strongly supports the FDA’s proposed order for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support devices to remain in Class III with Premarket Approval applications (PMA) required. The evidence of safety and effectiveness for these indications has not been established, and the benefit/risk profile for these devices is “unknown.”
However, we strongly oppose the FDA’s proposed order to down-classify Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass from Class III to Class II with special controls. A major problem with this proposed order is that it splits the device into two classifications (Class III and Class II). A down classification from Class III to Class II (and 510(k) clearance) would not require a sponsor to prove that their product is safe or effective. FDA has noted seven significant risks associated with these devices, including risks that “can result in debilitating or fatal complications such as stroke, peripheral emboli, or death. To mitigate the risk of stroke or death, FDA is proposing special controls but these controls rely on non-clinical testing and non-clinical performance evaluation. These special controls are inadequate to provide reasonable assurance of safety and effectiveness for these complex, life-supporting devices.

April 12, 2014—AMWA as a member of the Patient, Consumer, and Public Health Coalition is expressing our grave concern about the March 12, 2014 FDA meeting of the Microbiology Medical Devices Panel of the Medical Devices Advisory Committee. Under consideration was the premarket approval of a new indication for the Cobas HPV test, as a first-line primary screening tool for cervical cancer in women aged 25 and older. This is a radical change to current U.S. Preventive Services Task Force (USPSTF) guidelines, which recommend Pap smears every 3 years starting at age 21, with the option of replacing that regimen starting at age 30 with a combination of a Pap smear and HPV test. As the American College of Obstetricians and Gynecologists (ACOG) stated in its comments to FDA regarding the lack of evidence for this proposal, “There is little comparative effectiveness data comparing primary HPV screening with co-testing, the preferred method in the ACS-ASCCP-ASCP guideline….providers will not be able to adequately counsel patients regarding the relative benefits and potential harms of primary HPV screening compared with currently accepted methods, particularly co-testing.” Although FDA scientists and several members of the advisory committee expressed safety concerns about this radical shift, they voted in favor of approval. The new indication is radical in several ways:
1) It replaces a safe and effective well-established screening tool and regimen that has prevented cervical cancer successfully in the U.S. with a new tool and regimen not proven to work in a large U.S. population, and is not supported by any evidence-based U.S. guidelines.
2) It interferes with the practice of medicine, by encouraging physicians to follow a positive result on the HPV test, which can identify a virus but cannot identify abnormal cells, with a colposcopy, an expensive and invasive procedure that could result in much lower compliance. For no apparent reason, the Pap smear is not used to follow-up on the HPV test to determine if cellular abnormalities have occurred.
3) The Pap smear is effective in detecting cellular signs of pre-malignancy that can be caused by HPV or other causes. The new indication would replace the Pap smear with the HPV test, which can only detect the virus (which usually will not cause cervical cancer) but will not detect cancers that are not caused by HPV.

April 13, 2014—Our Principles Working Group (NPWF, NPA, AMA, ACP, AOA, AAFP) has produced the statement below, modeled on the ACP principles that the AMA has also adopted.
As we discussed, the goal of this document is to reflect our values, provide some concrete application of them, but also keep it simple and streamlined to facilitate sign-on by all our varied organizations. Some of the language comes directly from the ACP principles (although the whole document hews closely to them, modified slightly to reflect the tone and purpose of our coalition).

Politicians are proposing and enacting an unprecedented number of measures that inappropriately infringe on clinical practice and on the relationship between patients and their personal health care providers—including physicians, nurses, and allied health professionals who provide patient care in clinical settings. These measures improperly compromise medical professionalism, often without regard for established, evidence-based care guidelines. Examples of political intrusion in the patient-provider relationship include:

• prohibiting providers from discussing with their patients risk factors that may affect their health, as recommended by evidence-based guidelines of care;

• requiring providers to provide—and patients to receive—diagnostic tests or medical interventions that are contrary to clinical evidence, the provider’s professional judgment, or patient preferences; and

• laws limiting the information that providers disclose to patients in patient care or mandating providers communicate information, the clinical relevance or content of which is not supported by scientific evidence or substantial public health concerns.

These challenges to the patient-provider relationship and to the agency of health care providers threaten evidence-based medicine, the delivery of quality care, and public health.

Our Coalition opposes government regulation or legislative action on the content of the clinical relationship between a patient and provider unless there is compelling scientific evidence of benefit to the patient, a substantial public health justification, or both, as supported by the scientific medical community.
GUIDING PRINCIPLES

Our Coalition works to ensure that the following principles are followed in health care policy that may impact the patient-provider relationship or clinical encounter:

1. Providers should not be prohibited by law or regulation from discussing with or asking their patients about risk factors that evidence shows may negatively impact their health or from disclosing clinically relevant information to patients.

2. The information and care provided should be consistent with the best available medical evidence on clinical effectiveness and appropriateness and professional standards of care.

3. The information and care should be tailored to individual patient circumstances and allow for flexibility as to the most appropriate time, setting and means of delivering information and care, as determined by the provider and patient.

4. The information and care provided should facilitate shared decision-making between patients and their providers, based on the best medical evidence, the provider’s knowledge and clinical judgment, and patient values, beliefs, and preferences.

April 24, 2014—AMWA as a Member of the Patient, Consumer, and Public Health Coalition applauds FDA’s efforts to clearly and effectively communicate risks and benefits to consumers in direct-to-consumer (DTC) advertisements. However, we are concerned about this study’s definition of “serious and actionable” risks, the diversity of the population being studied, the administration of the study in an online setting only, and the timing of the major statement in the ad (at the end of the ad instead of the beginning or middle).
Background
The FDA document describes research plans to analyze the effect of limiting risk information in the major statement in DTC advertisements. This proposal would compare giving limited risk information in the major statement (combined with a disclaimer statement alerting consumers of additional undisclosed risks) versus using a complete major statement (as is currently used).
The aim of the research is to identify differences in participant understanding of the disclosure and perception of the risks and benefits of a particular medication, product quality, sponsor trustworthiness, and interest in the product. There is concern that overly long major disclaimer statements lead to reduced consumer attention, thereby compromising understanding of the presented risks. 2

We also have specific concerns regarding this proposal as follows:

• The definition of “serious and actionable” risks must be clarified. This research proposal describes limiting risks mentioned in the major statement in DTC advertisements to those which are “serious and actionable.” However, no definition is given for what medical risks would fall into this category. Detailed and explicit criteria must be set for what risks will be considered “serious and actionable.” As an informative example of this definition, FDA should also state what specific information will be included in the four versions of the major statement used for each patient group during this investigation. It should also be noted that some patients and consumers may have different preferences towards acceptable risk levels. For example, patients with a disease that lacks effective treatment are likely to be willing to take greater risks than patients for whom treatments are currently available, even if imperfect. FDA should describe how its definition of “serious and actionable” will take such diversity into account.
• A diverse participant population must be ensured. This research proposal does not include any specific information about how exactly the participants will be recruited for the investigation, other than stating that recruitment will take place online. We are concerned that recruitment which occurs solely through the internet may bias the participant population to younger and more affluent and Internet-adept populations who have easy access to the Internet. In fact, the consumers most likely to be reached online may be those who are least likely to watch commercials on TV. FDA needs to describe in detail how it will ensure a diverse participant population in terms of age, race, gender, ethnicity, and educational background. These factors could heavily influence perception of the presented information, and thus skew the results of this investigation. As FDA plans to recruit participants who self-identify as having one of three possible medical conditions, the nature of these medical conditions could also introduce bias into the participant population. Care must be taken to ensure adequate diversity to reflect the general U.S. consumer audience.
• The study conditions must be as similar to real life situations as possible. This proposal describes the study as being administered in an online setting only. This situation, under a conscious test scenario, sitting close to a personal computer, is very different from the situation in which direct-to-consumer advertising usually takes place, which is often during leisure time in the presence of other distractions, where the consumer often sits further from the screen. FDA should consider ways to make its test protocol more realistic in order to account for these differences.
• Other changes to the major statement, such as timing, should also be considered in the test. Given that the major statement usually occurs at the end of an advertisement, having a shorter major statement alone may not guarantee increased consumer comprehension under real world situations. One consideration would be to introduce another version of the advertisement to the test protocol, in which the major statement is 3 given earlier in the advertisement, when a greater proportion of consumers may be paying attention. Lastly, we must note that the length and types of risk information provided in direct-to-consumer advertising are not the only variables that influence whether patients pay attention and understand that information. For example, TV commercials continue to provide risk information while visual and auditory stimuli are distracting the viewer from the risks being listed. In other words, the FDA has continued to allow companies to design and use ads that are clearly intended to persuade consumers to request their products and to encourage them to ignore risk information, rather than to educate them about the true risks and benefits. In the absence of comparative effectiveness research, the FDA also continues to approve new medical products with little benefit compared to other treatment alternatives, and then regularly gives companies numerous opportunities to mislead consumers in their advertisements, using a much lower threshold for accuracy than the FTC’s criteria of “misleading the average consumer” for food and supplement advertising.
April 30, 2014—As member of the Patient, Consumer and Public Health Coalition of the NRC (now the National Center for Health Research! (formerly National Research Center for Women & Families), AMWA signed onto a letter asking the FDA to disapprove the HPV test as a first line diagnostic tool for cancer of the cervix. The answer from the FDA claims that the data are not flawed, but Roche’s own published article about the ATHENA trial admitted that it had substantial flaws, and the FDA admitted that the comparator was not consistent with current guidelines. The FDA is passing this on to the medical societies. NCFHR’s letter from the FDA can be obtained from AMWA or NCFHR.
May 15, 2014—AMWA signed onto a letter generated by the Breast Cancer Coalition organized by Healthy Women to Senators Blunt and Brown and Representatives Lance and Christensen for introducing H>R>1984/S.931, the “Breast Cancer Patient Education Act”. This educational effort would inform women that breast reconstruction is possible at the time of breast cancer surgery, it may delayed until after other treatments, or they may choose not to have reconstruction and be informed of the availability of prostheses or breast forms. Also, this bill will increase awareness about the federal law that requires coverage of breast reconstruction, even if such reconstruction is delayed until after other treatments. Each year, hundreds of thousands of women in the United States are diagnosed with new cases of invasive breast cancer. African American women under the age of 40 have much higher incidences of breast cancer than Caucasian women of the same age and breast cancer is the most common form of cancer in Hispanic/Latina women. Because of this, H.R. 1984/S. 931 focuses on informing patients who are members of racial and ethnic minority groups.

May 15, 2014— AMWA signed onto a letter generated by the National Women’s Health Network to the FDA addressing concerns about flibanserin, a drug for female sexual dysfunction. We oppose approval because the minimal effectiveness is outweighed by the side effects and lack of long-term safety data. We also signed onto the same organization’s letter to Congress to ensure that Members of Congress who work on women’s health and drug safety have information about why we oppose approval. Flibanserin is currently under FDA review for a 3rd time. We’ve opposed approval of this drug twice before because of a lack of effectiveness that is outweighed by the drugs side effects and the lack of longer-term data for which the FDA twice denied approval. This letter also addresses our concerns about recent claims of gender bias in the FDA’s review of this drug. The FDA sent us a noncommittal letter in response to our April 8, 2014 letter regarding flibanserin.
May 20, 2014—The National Osteoporosis Foundation (NOF) is hosting a briefing in the U.S. House of Representatives (a widely attended event) to provide public representatives and guests with updated information on the prevalence of osteoporosis in the United States. NOF generated its first report on the burden of osteoporosis and low bone mass in 2002. Recently, NOF released new prevalence data and will offer information at this briefing regarding prevalence of the disease in each state and among diverse populations. Drs. Diane Helentjaris and Omega Silva attended an earlier briefing on osteoporosis and fracture prevention by using the DXA scan sponsored by Capital Counsel. Both of them went to the morning briefing on this on April 30th and Dr. Silva was able to do some afternoon hill visits, too in the offices of Senators Warren, Sherrod Brown, Robert Casey, Roger Wickerand Ben Cardin, as well as Rep. Marcia Fudge, . Next day Dr. Helentjaris went with a small group to meet with the White House staff person, Hallie Schnier, heading up Community Engagement. Basically the advocates have drafted legislation to address federal reimbursement rates for bone density testing which currently is so low that services are less available and screening rates are declining. The goal with the White House was to have them sponsor a meeting to help get the word out about the benefits of screening, etc. The WH staff was fine with this – Hallie Schnier was very generous with her time.

June 3, 2014—AMWA has been asked to consider taking a role as an amicus in an important case pertaining to the rights of terminally ill New Mexicans. As you may know, two Albuquerque oncologists (including one who is an AMWA member, Dr Katherine Morris) and a Sante Fe woman with advanced cancer brought a lawsuit seeking to establish the right of mentally competent terminally ill New Mexicans to choose aid in dying. Kathryn Tucker with whom AMWA has worked in the past is one of the attorneys representing these plaintiffs, in concert with the ACLU of New Mexico. The lawsuit advanced both statutory and constitutional claims; the trial court held in plaintiffs’ favor in January, 2014, stating:
“This Court cannot envision a right more fundamental, more private or more integral to the liberty, safety and happiness of a New Mexican than the right of a competent, terminally ill patient to choose aid in dying. If decisions made in the shadow of one’s imminent death regarding how they and their loved ones will face that death are not fundamental and at the core of these constitutional guarantees, than what decisions are? . . . The Court therefore thinks the patient has a right to choose aid in dying is a fundamental right under our New Mexico Constitution.”
Morris v. Brandenberg, No. D-202-CV-2012-02909, slip op. at 6, 13–14 (N.M. Dist. Ct. Jan. 13, 2014), available at https://newmexico.tylerhost.net/ServeDocument.ashx?SID=0730da82-c2ce-4331-9d34- 98fe74190124&RID=001664dd-e045-4d6c-b5ce-1294189b0a7a., at 12–13.

The decision has been appealed. As counsel to the plaintiffs we would very much welcome the participation of AMWA as an amicus, a “friend of the court”, as we believe it can assist the appellate court in understanding that aid in dying is a legitimate, compassionate medical choice that can be safely provided without harm to patients or adverse impact on physicians. AMWA adopted policy strongly supportive of aid in dying in 2007, after exhaustive consideration of the issue and examination of the data and literature available concerning the practice. The AMWA policy states, in pertinent part:
“AMWA believes the physician should have the right to engage in practice wherein they may provide a terminally ill patient with, but not administer, a lethal dose of medication and/or medical knowledge, so that the patient can, without further assistance, hasten his/her death. This practice is known as Aid in Dying…. AMWA supports patient autonomy and the right of terminally ill patients to hasten death. AMWA also believes the physician should have the right to engage in physician assisted dying.”

Dr Haffizulla thinks we should engage the Board in this decision to prevent dissension since the position paper was done many Boards ago. Boards usually do not change position papers unless it is time for review. Then someone has to take on the review and revision.

June 3, 2014—AMWA has been asked to sign a letter of thanks to Majority Leader Reid for his participation in the nonrepeal of the 2.3% excise tax on medical devices (an important funding source for the Affordable Care Act) to the Tax Extenders Act. Majority Leader Reid stopped that from happening.

June 6, 2014—The Healthcare Coalition organized by the National Center for Health Research responded to Rep. Jim Cooper’s request for input into the bill requiring the FDA through its expedited pathway for drugs intended for both sexes to include clinical trials with sufficient numbers of men and women to statistically be able to report outcomes by sex. AMWA has decided to sign onto the support letter.

July 2, 2014—AMWA is a member of the National Center for Health Research’s Patient, Consumer, and Public Health Coalition, many of which have worked with Rep. Diana DeGette for years. We are writing to you express our concerns that you have not worked with us in your role as a leader in the 21st Century Cures project. Knowing of our shared policy positions on a wide range of issues, it is very surprising to us that our perspectives have not been represented at the hearings thus far, or in the first white papers. Our organizations have been among the most active independent nonprofit organizations on FDA issues, and include major consumer, scientific and public health organizations. We want to be supportive of your efforts to work in a bipartisan manner to ensure that Americans have the best possible medical treatments, and to ensure that our perspectives as patients, consumers, physicians, scientists, and public health experts are reflected in the 21st Century Cures effort. The white paper focuses on speeding approvals of medical products without paying adequate attention to making sure that FDA’s essential safeguards are protected for men, women, children, and regarding prenatal exposures.

July 2, 2014—AMWA signed onto the Research Act of 2014 to ensure data transparency and gender equity in NIH and FDA Research as well as safe and effective trials for expedited drug products.

July 13, 2016—AMWA signed in support of the Pregnant Workers Fairness Act (S 942/HR 1975). The President recently announced his support for the bill, and we hope that a provider/health professional letter will help keep that positive momentum and gather bipartisan support. Many organizations signed on to a similar health letter last year. There will be two letters — one to the House and one to the Senate. Three-quarters of women will be pregnant and employed at some point in their lives. For most women, pregnancy complications are few and a healthy birth follows. However, some pregnant women will need to make minor adjustments in their work activities, as recommended by their health care providers, in order to sustain a healthy pregnancy. These medically necessary accommodations can include more frequent bathroom breaks, opportunities to stay hydrated, lifting restrictions, or access to a chair or stool to decrease time spent standing. This bill will provide for these adjustments.

July 13, 2014—AMWA has been asked to comment on a letter to supporting the FDA’s proposed framework on the “Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report” Docket No. FDA-2014-N-0339.
As members of the Patient, Consumer and Public Health Coalition, we appreciate the opportunity to comment on the above. The Food Drug and Administration Safety and Innovation Act (FDASIA) required the Food and Drug Administration (FDA) to work in consultation with Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) to prepare a report on a framework for health information technology (IT), including mobile medical applications. The report reviews strategies to promote innovation, protect patient safety and avoid regulatory duplication. We are unable to support the proposed framework because we are very concerned that it will undermine the FDA’s mission to protect the public health. The framework “primarily relies” on the ONC and private sector capabilities to coordinate activities with FDA and FCC, which leaves the FDA in a secondary role. The FDA has overseen medical devices, including medical device software, for nearly four decades. The Agency has been regulating software on mobile platforms for more than a decade and has cleared approximately 100 mobile medical apps such as ECG machines and smartphone-based ultrasounds.1 2

We strongly disagree with the report’s recommendation that “no new or additional areas of FDA oversight are needed.” Since many health IT products—especially mobile medical applications–are in their infancy, we do not know how much FDA oversight these products will require. To broadly state that no new FDA oversight is needed is premature and dangerous.
The report focuses on the potential benefits of health IT and downplays the risks. For example, in the Introduction section, there is a long paragraph about the “tremendous benefits” of health IT followed by a single sentence that “it can pose risks to patients.” In fact, poorly regulated health IT devices can seriously harm huge numbers of patients, and can be fatal.

July 22, 2014—AMWA has signed onto a letter to key Senators about the need for generic drug companies to be able to make safety updates to their products’ labeling. We strongly oppose the House Language which delays the FDA proposed rule and are asking Senators to make sure that it is not included in any final appropriations report for the Food and Drug Administration, or any other legislation. Allowing the generic manufacturers to initiate safety updates, as brand-name companies have done for 30 years, is essential to patients and consumers, as promptly updated warnings can provide informed consent to patients and physicians and prevent serious harm to patients.

July 23, 2014—AMWA signed onto a letter agreeing with the conclusions drawn by the U.S. Preventive Services Task Force: There is insufficient evidence to propose recommendations for or against screening for vitamin D deficiency in adults who have symptoms associated with such deficiency. Without a clear consensus on how to define vitamin D deficiency, screening could lead to misclassification, over-diagnosis, under-diagnosis, or unnecessary use of the available screening tools. Any of these outcomes could do more harm than good.

July 22, 2014—AMWA signed onto a letter to oppose the FDA’s draft guidance on high-risk devices. It shifts the risk-benefit paradigm so that patients face greater risks. It states that the Expedited Access PMA program “will help patients have more timely access to these medical devices.” While patients want access to devices that meet unmet medical needs, few patients are willing to risk their lives to do so, especially if a few more months of research could result in devices that are proven to be safe and effective. The standards for PMA devices (high-risk devices) are already substantially lower than for prescription drugs. Most PMA devices are approved through supplements that do not require clinical trials. Original PMA clinical trials are often small and short-term with limited use of control groups. And yet, the FDA’s new draft guidance lowers the bar for certain PMA medical devices even further.
July 28, 2014—The FDA has issued a proposed order to reclassify trans-vaginal surgical mesh for pelvic organ prolapse (POP) repair from class II to class III because of serious safety risks. This change means that the FDA will require manufacturers to collect more rigorous evidence for these devices by conducting pre-market clinical studies. However, the FDA has created a loophole by not up classifying surgical mesh for stress urinary incontinence (SUI) – so mesh for this purpose will be able to get on the market more easily with less evidence. AMWA supports requiring more data on surgical mesh by up-classifying mesh for POP and urging the FDA to also up-classify mesh for SUI agreeing with the National Women’s Health Network which initiated the letter.

July 28, 2014—AMWA signed onto a letter generated by the AMA concerning CME activities and how they are funded as written in the Sunshine Act by requiring CMS
Administrator Tavenner to change the implementation of the Physician Payment’s requirements. In the proposed Medicare Physician Fee Schedule for 2015, CMS has proposed revoking the exclusion from reporting under the Sunshine Act of transfers that manufacturers/GPOs make to organizations that offer independent CME accredited by the ACCME or where credit is granted by AAFP, AMA, AOA, or the American Dental Association. Instead, the Agency would exempt third party transfers to CME only where an industry donor is unaware of the recipients/beneficiaries before and after the funds are transferred. This raises concerns as industry could learn the identities of speakers and participants after the funds have been transferred through brochures, programs, and other publications related to a CME event. The AMA believes that this policy will have a chilling effect on CME. Consequently, those organizations signing on are asking the Agency to slightly modify the proposal to exclude CME activities where the industry donor is unaware of the speakers and other participants before committing to fund the activity. The letter also outlines concerns with how the Open Payments System has been implemented, including the condensed registration time frame and the complicated and incomplete guidance from the agency. We also ask the Agency to reconsider its decision not to cover journal article reprints within the existing statutory exclusion for educational materials that directly benefit patients, to provide clarifying guidance that manufacturers and GPOs are not included in this ruling.

August 3, 2014—Dr. Diane Helentjaris attended a briefing at the Association of the College of Obstetrics and Gynecology on the legislative interference in the doctor/patient relationship and that ACOG would be studying this phenomenon probably on a state by state basis and the meeting was also to inform those attending that ACOG had interns rotating through their office who may be helpful to other organizations.

August 3, 2014—AMWA was asked to sign onto an Amicus Brief pertaining to the rights of terminally ill New Mexicans. Two Albuquerque oncologists (including one who is an AMWA member, Dr. Katherine Morris) and a Santé Fe woman with advanced cancer brought a lawsuit seeking to establish the right of mentally competent terminally ill New Mexicans to choose aid in dying. Kathryn Tucker is one of the attorneys representing these plaintiffs, in concert with the ACLU of New Mexico. The lawsuit advanced both statutory and constitutional claims; the trial court held in plaintiffs favor in January, 2014, stating: “This Court cannot envision a right more fundamental, more private or more integral to the liberty, safety and happiness of a New Mexican than the right of a competent, terminally ill patient to choose aid in dying. If decisions made in the shadow of one’s imminent death regarding how they and their loved ones will face that death are not fundamental and at the core of these constitutional guarantees, than what decisions are? . . . The Court therefore declares that the liberty, safety, and happiness interest of a competent, terminally ill patient to choose aid in dying is a fundamental right under our New Mexico Constitution.”
Morris v. Brandenberg, No. D-202-CV-2012-02909, slip op. at 6, 13?14 (N.M. Dist. Ct. Jan. 13, 2014), available at https://newmexico.tylerhost.net/ServeDocument.ashx?SID=0730da82-c2ce-4331-9d34- 98fe74190124&RID=001664dd-e045-4d6c-b5ce-1294189b0a7a., at 12?13.

The decision has been appealed. As counsel to the plaintiffs we would very much welcome the participation of AMWA as an amicus, a “friend of the court”, as we believe it can assist the appellate court in understanding that aid in dying is a legitimate, compassionate medical choice that can be safely provided without harm to patients or adverse impact on physicians. AMWA adopted policy strongly supportive of aid in dying in 2007, after exhaustive consideration of the issue and examination of the data and literature available concerning the practice. The AMWA policy states, in pertinent part:
“AMWA believes the physician should have the right to engage in practice wherein they may provide a terminally ill patient with, but not administer, a lethal dose of medication and/or medical knowledge, so that the patient can, without further assistance, hasten his/her death. This practice is known as Aid in Dying. AMWA supports patient autonomy and the right of terminally ill patients to hasten death. AMWA also believes the physician should have the right to engage in physician assisted dying.” AMWA agreed to sign on if it had no financial responsibilities in producing the brief. Our officers and counsel will give their agreement when the brief is ready.

August 3, 2014—AMWA was asked to support a house bill H.J. Res 56 / Equal Rights amendment which states:
Section1. Women shall have equal rights in the United States and every place subject to its jurisdiction. Equality of rights under the law shall not be denied or abridged by the United States or by any State on account of sex.
`Section 2. Congress and the several States shall have the power to enforce, by appropriate legislation, the provisions of this article.
`Section 3. This amendment which shall take effect two years after the date of ratification, NWHM / H.R. 863 Commission to Study the Potential Creation of a National Women’s History Museum Act has-98 Bipartisan cosponsors. It passed the house of reps 383-33 and is currently stalled in the senate. It requires ZERO taxpayer dollars to establish a commission to study the feasibility of a National Women’s History Museum on or near the national mall.

August 4, 2014—AMWA was asked to sign on to the mesh reclassification comments to the FDA, [Docket No. FDA-2014-N-0297] Comments on “Reclassification of Surgical Mesh for Trans-vaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Uro-gynecologic Surgical Mesh Procedures; Designation of Special Controls for Uro-gynecologic Surgical Mesh Instrumentation. [Docket No. FDA-2014-N-0297] Comments on “Reclassification of Surgical Mesh for Trans-vaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Uro-gynecologic Surgical Mesh Procedures and designation of Special Controls for Uro-gynecologic Surgical Mesh Instrumentation. As members of the Patient, Consumer, and Public Health Coalition, which includes nonprofit organizations and individuals that represent patients, consumers, physicians, scientists, and researchers, we welcome the opportunity to comment on the Food and Drug Administration’s proposed order to reclassify surgical mesh for trans-vaginal pelvic organ prolapse (POP) repair from class II to class III and surgical mesh instrumentation from class I to II. The Coalition is dedicated to evidence-based medicine that is used to improve the health and safety of patients and consumers.
We are writing to express our strong support for the FDA’s proposal to up classify both surgical mesh for POP repair and surgical mesh instrumentation. This change will help to ensure that devices intended to improve women’s heath are supported by evidence of safety and effectiveness. We would also like to express our strong concerns that the agency has not proposed reclassification of surgical mesh for stress urinary incontinence (SUI) from class II to class III. All trans-vaginal surgical mesh products – no matter the indication – should be evaluated via the premarket approval (PMA) pathway. Surgical mesh is a permanent implant, failure of which can and has caused serious adverse health consequences for hundreds of thousands of women. Reclassification of both indications would be the best way to ensure that the trans-vaginal surgical mesh products women rely on are safe and effective by establishing consistency across the device review process.

August 4, 2014—AMWA staff was asked to help a Medscape writer answer the question about the impact that TV medical shows featuring celebrity physicians are having on real-life doctors. (To be clear, this is not about fictional, TV dramas, but about those featuring real doctors providing medical information.) Do television shows (such as Dr. Oz, The Doctors, etc.) provide a service or a disservice to patients?
– Do they change the way patients interact with or their doctors? Do patients come into the office having diagnosed themselves based on what they’ve watched or seeking treatments they’ve heard about on TV? Are they as apt to listen to their doctor if she contradicts what they’ve heard on television?
– Is this influence different from other forces that may sway patients? People certainly gather a lot of medical information from the internet and from television/magazine advertisements. Is this phenomenon any different? If it is, how is it? Our staff forwarded this inquiry to our membership who will answer directly and AMWA will get feedback for the reporter.

August 4, 2014—The Pew Charitable Trust asked AMWA to support an inquiry to ask the FDA on its Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (Docket No. FDA-2014-D-0609). We thank the U.S. Food and Drug Administration for the opportunity to provide comments on draft guidance for the identification of suspect pharmaceutical product and the associated process to notify affected supply chain stakeholders of illegitimate product – foundational elements of the Drug Supply Chain Security Act. The draft guidance covers a wide range of risk factors that companies should consider when screening for suspect product, including product sourcing, market signals, and product appearance. This breadth of scope in the guidance should be maintained. However the FDA should also add clarity to its recommendations to ensure supply chain sectors can meaningfully operationalize them, and should provide guidance to help stakeholders differentiate between scenarios of higher and lower risk.
We have provided five general recommendations on the draft guidance:
1. Maintain breadth, but differentiate scenarios by level of risk: FDA should differentiate scenarios by level of risk and identify distinct responses from industry supply chain stakeholders for each scenario. FDA should also add detail to more carefully define the characteristics of specific scenarios.
2. Add specificity on handling incomplete transaction information: FDA should include recommendations to industry supply chain stakeholders on how to address incomplete transaction information that may be due to inadvertent errors.
3. Clarify validation of transaction history (chain of custody): The FDA should identify and explain the steps industry supply chain stakeholders should take to validate transaction histories (chain of custody) when investigating suspect product.
4. Include standard operating procedures to screen for suspect product: FDA should recommend that companies develop and implement standard operating procedures for screening and designating a product as potentially suspect.
5. Encourage proactive serial number checking as screen for suspect and illegitimate product: FDA define best practices in guidance to not only allow industry supply chain stakeholders to comply with the law, but to also encourage proactive and possibly automated checks of unique serial numbers on individual packages of drug product at routine points of distribution throughout the supply chain.
August 4, 2014—The coalition to Protect the Patient-Provider Relationship, is a broad-based national coalition based on the statements from the AAP, AMA, AAFP, and ACP. The undersigned members of the Coalition to broad-based national coalition of nonprofit, nonpartisan organizations, united in our opposition to inappropriate interference in the relationship between a patient and healthcare provider, are deeply disappointed in the 11th Circuit Court of Appeals’ recent ruling on a Florida gun safety counseling law.
In upholding the Florida law restricting physician counseling on firearms safety, the 11th Circuit ruled that there is no First Amendment protection for physicians who routinely ask about the presence of a gun in the home in order to offer appropriate safety counseling to patients and families. Firearms safety education of both children and adults has been shown to decrease the likelihood of unintentional injury and death and is recommended by major medical associations. This issue is much bigger than gun safety–it is about governmental intrusion on patients’ relationships with their medical professionals. Relationships built on trust and respect. Laws that infringe on this relationship put the patient and their family’s health at risk. Physicians and other medical professionals should not be prohibited by law or regulation from discussing with or asking their patients about risk factors that may negatively impact their health. The information and care provided should be consistent with the best available medical evidence on clinical effectiveness. Plaintiffs in the case are petitioning the court for a rehearing. The coalition supports efforts to pursue additional legal remedies in this case to ensure patient relationships with their medical providers are protected. AMWA as a member of the Coalition formed by the National Center for Health Research is very supportive of this coalition’s position on gun safety.

August 6, 2014—AMWA as part of the National Center for Health Research Coalition has agreed to sign onto the Deeming Rule for tobacco products which now are under the jurisdiction of the FDA as a delivery system for nicotine as amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Extension of Comment Period (Docket No. FDA-2014-N-0189). It is essential that the proposed rule be strengthened, since nicotine is highly addictive. We strongly oppose exempting any cigars from the rule, including those designated as “premium.” We also strongly oppose exempting or weakening the rules for smaller manufacturers or manufacturer of “premium” tobacco products, regardless of their so-called “unique challenges.” The FDA’s proposed rule does not go far enough to safeguard the health of young people. It proposes a national minimum age of 18 for the purchase of the newly deemed products, which we wholeheartedly endorse, but it permits sale through the internet where age verification is difficult if not impossible to enforce. The proposed rule does not go far enough to restrict the marketing and advertising of e-cigarettes and cigars to minors. We strongly support the FDA’s proposal to include health warnings about nicotine addiction on all nicotine-containing tobacco products, including e-cigarettes and cigars. We also urge the FDA to strengthen the proposed rule regarding characterizing flavors in cigars or e-cigarettes. Cigarettes, for instance, can only be sold with tobacco-flavor or menthol flavor; the newly deemed products should be held to the same standard as they are similarly addictive, nicotine-containing products. The proposed rule does not mention requiring child-resistant packaging of liquid nicotine for use in e-cigarettes. The FDA is proposing a premarket review requirement for all newly deemed products, while recommending that manufacturers have 24 months from the final rule to file substantial equivalence and new product applications. This would allow manufacturers to keep existing products on the market and introduce new deemed products for two full years following the promulgation of the final rule. It would also allow products for which an application has been submitted to stay on the market unless or until FDA denies it. These loopholes are unacceptable, given that there has already been a 3-year delay in issuing the deeming rule, giving companies more than enough time to prepare for regulatory requirements.
August 12, 2014—As a member of the coalition AMWA signed onto the “Comments of the members of the Patient, Consumer, and Public Health Coalition on the Draft Guidance Appropriate Use of Voluntary Consensus Standards in Premarket submissions for Medical Devices”, Docket No. FDA-2014-D-0456. The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.” We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.” We would strongly oppose any reduction in the already limited information regarding safety, effectiveness, or substantial equivalence. Although we strongly support sections of the draft guidance that clarify the limitations of consensus standards, we are concerned that the use of consensus standards could lead to less stringent requirements for evidence of safety and effectiveness or substantial equivalence for medical devices. The standards for approval and clearance are already dangerously weak and subjective, and efforts to be more “flexible” or accommodating to consensus standards would put patients at serious risk.
August 21, 2014—Dr. Silva accompanied the Coalition formed by the NCHR to a meeting with the Health Policy Director, Rachel Stauffer, for congresswoman Diana DeGette of Colorado who is a member of the Energy and Commerce Committee to discuss our concerns about the 21st Century Cures Initiative which involves the FDA’s control over approval of drugs and devices; the coalition feels that good response times should be matched with a thorough study of the drug or device and the post surveillance tracking should be restructured.

August 21, 2014—AMWA as a member of the Patient, Consumer and Public Health Coalition of the NCHR, urges the FDA to withdraw its guidance on the use of scientific literature to communicate new risk information to clinicians and health care facilities. The rationale of this guidance is to allow rapid distribution of risk information in the interest of public health, yet it only addresses published literature claiming risks that are lower than that presented on the label, which has the potential to cause confusion and greatly harm patients. This guidance would undermine the public health mission of the FDA by allowing companies to provide inaccurate “scientific” information which patients and their physicians would use to allow the distribution of critical risk information prior to formal changes to label information. It is in Docket No. FDA-2014-D-0758.

August 21, 2014—This fall the Supreme Court is going to hear oral arguments in Young v. UPS, a pregnancy discrimination case about whether employers must allow pregnant workers modest job accommodations to the same extent the employer provides them for other groups of employees. The National Partnership is leading an amicus brief focused on the health impacts of being denied simple job accommodations. The American Medical Women’s Association will join the brief.

September 9, 2014—AMWA has been asked to sign onto the Morris amicus brief concerning death and dying in New Mexico being done by Kaveh Sabo and Christina Kuhn at Covington and Burling in DC with the help of Kathryn Tucker, someone AMWA has worked with much in the past.

September 21, 2014—AMWA has been asked to sign onto a letter to The Honorable Henry Waxman, Ranking Member of the Energy and Commerce Committee, United States House of Representatives as a member of the Patient, Consumer, and Public Health Coalition organized by the National Center of Health Research, which includes organizations representing patients, consumers, physicians, and scientists, writing to express our strong concerns about proposed legislation to speed the development of new antibiotic drugs, H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013. Antibiotic resistance is of grave concern, but this legislation will create more problems than it will solve. Although the ADAPT Act would do nothing to address the root causes of antibiotic resistance (it is intended to promote antibiotic drug development) the unintended consequences would be to harm patients and threaten the public health. If passed, patients will be paying to take drugs that are not proven to improve patient health or save patients’ lives. It lowers the standards of safety and efficacy, reduces diversity in clinical trials and encroaches of the jurisdiction of the FDA, denies safeguards to protect larger patient populations, lacks provisions to protect and preserve new and existing antibiotics, ignores causes of antibiotic resistance, adds unneeded redundancy to existing legislation and regulations. We look forward to working to create legislation that can provide real and effective solutions to the problem of antibiotic resistance. Such legislation would directly confront the real causes of antibiotic resistance, rather than advocating shortcuts that compromise patient safety, exclude neglected patient populations, accelerate antibiotic resistance, and undercut the recommendations and priorities of the FDA, the CDC, and the NIH.
September 21, 2014—AMWA as a member of the Patient, Consumer and Public Health Coalition, appreciates the opportunity to comment on the proposed rule, “Medical Device Classification Procedures.” The Food and Drug Administration (FDA) is “proposing changes to the definition of Class III to provide greater clarity regarding which devices fall within this class, and to improve transparency and predictability in device classification and reclassification decisions.” We commend the FDA for seeking clarity but we have grave concerns about the ways that the proposed rule weakens current definitions of Class III devices. The proposed rule lowers the threshold of evidence for class III devices, includes five categories of devise for classification into class III, devices with unknown or unfavorable risk-benefit profiles, Class IIb devices, combination products, and implantable devices intended for use in supporting or sustaining human life. We strongly recommend that all high risk devices be categorized as class III, as the law intended. FDA should follow the FD&C Act that “explicitly reserves class III to devices that are intended for use in supporting or sustaining human life, are of substantial importance in preventing impairment of health, or that present a potential unreasonable risk of illness or injury.” We also strongly recommend that implants and combination devices be categorized as Class III.
September 24, 2014—AMWA has signed onto a letter to Senators Sherrod Brown (D-OH), Richard Blumenthal (D-CT) and Rep. Rosa DeLauro (D-CT) who are introducing a bill to prohibit medical insurance plans from dropping doctors in the middle of the year. It also ensures that people with Medicare are given help and information in finding new doctors when necessary. National Physician Alliance is joining with the Medicare Rights Center and the Center for Medicare Advocacy to support this Medicare Advantage Participant Bill of Rights Act. The letter will be delivered in the next few weeks to the committee chairs and ranking members of the House and Senate committees where the bill has been referred.
October 14, 2014—Comments of Members of the Patient, Consumer, and Public Health Coalition on Draft Guidance “Intent to Exempt Certain Class I,I and Class I Reserved Medical Devices from Premarket Notification Requirements”.
AMWA, as a member of the Patient, Consumer, and Public Health Coalition, appreciates the opportunity to comment on the draft guidance, Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements. The draft guidance lists the medical devices that the Food and Drug Administration intends to exempt from premarket submission requirements. The draft guidance states that the devices identified in the guidance “are sufficiently well understood and do not present risks that require premarket notification (510(k)) review to assure their safety and effectiveness.” We strongly disagree. Some of the devices do “present risks” and should require the scrutiny provided by 510(k) reviews. After checking for adverse event reports in the Manufacturer and User Facility Device Experience (MAUDE) database for the devices listed in the draft guidance, we found seven devices that had numerous MAUDE injury reports and several deaths associated with the devices. Since MAUDE reports are known to be the tip of the iceberg of adverse reactions, we question the CDRH decision to no longer require any scientific information be provided to the FDA regarding the devices listed below, and strongly urge that FDA enforce compliance with 510(k) requirements for them.
October, 14, 2014—AMWA signed-on to the Patient, Consumer, and Public Health Coalition comments re the major shortcomings in FDA’s draft guidance on benefit-risk factors for certain medical devices. These shortcomings will lead to less safe and less effective medical devices.
The three major shortcomings of the guidance are as follows:
1. It focuses on benefits and risks that cannot be accurately measured in the absence of large, long-term, well-designed clinical trials.
2. The wording of the guidance is vague and rather than clarifying the criteria for substantial equivalence, the guidance illustrates the very subjective decisions that the Food and Drug Administration (FDA) relies on.
3. The specifics regarding surrogate endpoints, emphasis on postmarket data, and patients’ perspectives on risk assessment would further reduce the already extremely limited safeguards available for medical devices cleared through the 510(k) process.
We oppose the draft guidance as written and strongly urge the FDA to rewrite it. The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments. When it is more specific, it promotes the use of surrogate endpoints and the risk tolerance of a small number of patients whose views come to the FDA’s attention.
October, 14, 2014—AMWA has signed onto Comments of Members of the Patient, Consumer, and Public Health Coalition on Draft Guidance “De Novo Classification Process (Evaluation of Automatic Class III Designation)” [Docket No. FDA-2011-D-00689] As a member of the Patient, Consumer, and Public Health Coalition of the National Center for Health Research, AMWA has serious reservations about the use of the de novo classification process for implants, life-sustaining, and life-saving devices. We believe that all such high-risk devices should be Class III devices reviewed through the more rigorous PMA process. That is why we urge CDRH to revise the draft guidance to explicitly state when the de novo process may be used and when it cannot be used. We strongly support language in the draft guidance that states the de novo process should be used for devices that are “low to moderate risk” (Class I or Class II devices). We also support language that states, “The de novo should include all (emphasis added) information and evidence regarding the safety and effectiveness of the device,” and “provide data demonstrating that general controls or general and special controls support a classification of Class I or Class II.” However, we urge the FDA to revise the second sentence to read: “provide publicly available scientific data and test results demonstrating that general controls…support a classification of Class I or Class II.” In conclusion, the de novo process should be used to strengthen the approval standards for low-to-moderate risk devices by replacing the 510(k) process. It should not be used to lower the approval standards for high risk (Class III) devices, which should always be reviewed through the more stringent PMA process. We strongly urge the FDA to revisit their classifications of many implants, 95% of which now go through the 510(k) process, according to recent research.1 We also urge the FDA to reconsider the Class II classifications of many other life-sustaining and life-saving devices that have also been cleared through the 510(k) process based on predicates that differ substantially from the new devices in ways that have clear implications for safety and effectiveness, such as surgical robotic systems that were cleared as substantially equivalent to surgical tools. To protect public health and ensure that medical devices provide a reasonable assurance of safety and effectiveness, the draft guidance must unambiguously describe when the de novo process may and may not be used to clear a medical device.
October 21, 2014—Dr. Kim Witzcak, Lauren Doamekpor (on behalf of our coalition) and Diana Zuckerman (National Center for Health Research with Dr. Witzcak were proud to represent the voices of families who live every day with the consequences of a failed drug safety system. In an unusual but ominous move the FDA had two advisory committees (Psychopharmalogic and Risk Communications) consider Pfizer’s request to remove the Boxed Warning about the serious psychiatric side effects of Chantix.

Pfizer’s case (with two rows of paid experts to explain) was that their clinical trials evidence and 4 observational studies proved no such effects existed. They got 2.5 hours to make their case. It was fun watching the huge constituency of Pfizer and their cronies — arrogant and pretty cocky about their studies. And even more fun to watch them walk out pretty humiliated.

There was a citizen petition that was sent to FDA in advance of hearing. It was created by Tom Moore created was had 5 strong supporting organizations to endorse it, including Consumer Reports, National Physicians Alliance, National Center for Health Research, and Public Citizen). I have attached it in case you are interested in reading it. Its very enlightening and believe it was helpful for this hearing.

A couple of my observations contrasting the Chantix hearing to the antidepressants hearings back in 2004/2006.

1) The FDA actually presented a qualitative review of the type of adverse events from their Medwatch system. They challenged how comments like “feeling like a zombie” which wasn’t a diagnosis would be coded. Compare this to antidepressant hearings where we were told our stories/experiences were “anecdotal” because it didn’t happen in a double blind controlled placebo study. It was nice to see the FDA not ignoring the real world narrative. There were way too many reports, despite Pfizer’s attempt to blame the victim and their underline mental health and issues of cessation withdrawal.

2) There were no Chantix victims to describe first-hand what it was like for them or their loved one. That’s because the 2700 victims were silenced in their settlement agreements with Pfizer. Pfizer learned from the antidepressant hearings where it was victim after victim telling their powerful story in the open public forum. It’s hard to ignore these real life experiences. So Pfizer shut them up.

Here’s a video that my advertising co-workers produced to help represent actual Chantix victims experiences. I opened my remarks with the video. Please feel free to share or use in your work.


3) In addition, there were no attorneys testifying during open public forum. During the antidepressant hearings there were several attorneys that spoke on behalf of their clients and about unsealed documents. All Chantix documents and discovery including expert depositions are forever sealed and public health knowledge is lost. It’s a shame and we need to get FDA to subpoena the records somehow. I am committed to working on this issue with some DC organizations. We need the FDA to get their hands on documents. In our litigation against Pfizer, my attorneys were able to get confidential documents unsealed where many of the psychiatric (including suicide) risks associated with these drugs were well known and documented before they were released to the public. Power in documents! What was the same, however, between the two hearings is how those with contrasting scientific/clinical evidence like Tom Moore (Chantix) and David Healy (antidepressants) were not allowed to present their findings. Rather they have to try and do within the allotted public hearing time. Even though we had a victory yesterday with the 18-1 vote, we will still need to keep an eye on the large post market safety study that will be completed in 3Q 2015. Pfizer’s attempt to blame the victim and their underlying mental health and issues of cessation withdrawal was evident.

October 29, 2014—The FDA has proposed truly frightening guidance for drug and device companies that want to promote their products on twitter, facebook, and other platforms with limited characters.
When companies advertise directly to consumers on TV or magazines, they are required to include all risk information on the label. This would NOT be required for these social media ads. The Food and Drug Administration (FDA) recognizes throughout this draft guidance the inherent difficulty in communicating adequate risk and benefit information through platforms that have very tight space limitations. The draft guidance states, “For some products, particularly those with complex indications or extensive serious risks, character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk.”
It is difficult if not impossible to think of many examples that could effectively communicate risks and benefits within strict space limitations without removing substantial amounts of risk information and relying heavily on links, given the complexity of risk and benefit information for most medical products. As a scientific agency devoted to public health, the FDA should not consider the policies proposed in this draft guidance without collecting data on how many consumers/patients would follow links to information about risks of medical products, compared to how many would read information that does not require one or more extra clicks to access.
The draft guidance explicitly states, “Risk information should be comparable in content and prominence to benefit claims within (emphasis added) the product promotion (i.e., a balanced presentation).” To achieve that goal, the amount of space should be comparable for risks and benefits and the reliance on links should be identical for risks and benefits.
Conclusions
The draft guidance notes, “The public health is best served when risk and effectiveness information about drug and device products is clearly and accurately communicated.” We agree. Unfortunately, social media platforms with character space limitations do not allow firms to provide “a balanced presentation of both risks and benefits of medical products.” On the contrary, it is a classic case of cramming a round peg in a square hole. This medium was not designed to provide enough information for patients to adequately access a product’s benefits and risks.
For these reasons, this draft guidance is unacceptable to those who care about public health and providing balanced information to patients and consumers. We strongly urge FDA to completely revise this draft guidance, so that it offers the possibility of improving the public health by providing patients and consumers with risk information on the par with promotional information.
December 14, 2014—AMWA endorsed the HEAL Immigrant Women & Families Act of 2014 in a letter to Health & Human Services Secretary Burwell re: access to health coverage and care for immigrants who obtain Deferred Action for Childhood Arrivals (DACA) or the recently announced Deferred Action for Parental Accountability (DAPA). Sec. Burwell publicly recognized the unfair policy barriers to affordable health coverage for young people who obtain DACA status. The undersigned organizations decided to take the opportunity to formally express their support for these comments and to emphasize that HHS has the authority to effect policy changes that would expand access to affordable coverage options both for DACA, and for DAPA, in light of the President’s recently announced executive order.

December 14, 2014—Many organizations including AMWA supported the FDA as it announced the availability of a new draft guidance describing the Agency’s annual reporting procedures for prescription drug wholesale distributors and third-party logistics providers as required under the supply chain provisions of the Drug Quality and Security Act. The draft guidance, Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers, outlines the information that should be submitted to FDA, the timing of the submissions, a preferred format for the submissions, and a preferred method for reporting to FDA. Annual reporting by third-party logistics providers and wholesale distributors can be made using FDA’s CDER Direct Electronic Submissions Portal. FDA also published the draft guidance on DSCSA Standards for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs: How to Exchange Product Tracing Information, to assist manufacturers, repackagers, wholesale distributors and dispensers to comply with the new product tracing requirements.

December 14, 2014—AMWA also signed onto the letter to President Obama generated by ACOG urging the Administration to reverse its previous actions and allow individuals granted DACA and DAP status to access affordable coverage options. H.R. 4240, the Health Equity and Access under the Law (HEAL) for Immigrant Women and Families Act introduced by Representative Michelle Lujan Grisham in March 2014 and supported by more than 200 national, state, and local groups, would help ensure that all lawfully present individuals in the United States have equitable access to affordable health coverage and care.

December 14, 2014—AMWA supported a letter generated by the Coalition organized by the National Center for Health Research to the FDA that high-risk cardiovascular devices should not be down-classified (lower standards for approval). In January 2012, members of the Patient, Consumer, and Public Health Coalition submitted comments opposing the down-classification of EPPG devices. The FDA stated that in 2012 it received the following comments on the proposed reclassification: EPPG devices should stay in Class III, that the reclassification was “not adequately supported by new publicly valid scientific evidence” and that the performance standards (special controls) “are insufficient.”3 Those comments are still valid today. The FDA has not provided any scientific evidence to contradict them.

December 14. 2014—AMWA was asked by the Green Science Policy Institute to protect the health of our population from halogenated flame retardants. The organization is in the final stages of preparing a Legal Petition for Rulemaking to the Consumer Product Safety Commission, asking for a regulation to ban all consumer products in four categories (children products, furniture, mattresses and mattress pads, and plastic electronics enclosures) if the product contains any organohalogen flame retardant. We have picked these product categories because organohalogen flame retardants are used extensively in these products and are known to migrate from the products leading to human exposures, despite the strong evidence that all halogenated flame retardants pose serious health concerns. We are asking CPSC to ban the class of organohalogen flame retardants (not just particular chemicals) because of the history of regrettable substitutions, which we explain in detail in the petition. There is a large regulatory gap when it comes to flame retardant chemicals. Even polybrominated diphenyl ethers (PBDEs), which are now strongly associated with human health harm (including carcinogenicity, immune and endocrine disruption, and adverse reproductive and neurodevelopmental effects), are not banned in any consumer product in this country. PBDEs are no longer produced in the United States, but no law prevents importing consumer products containing PBDEs.

December 18, 2014—AMWA is supporting the petition from the Green Science Policy Institute which is in the final stages of preparation as a Legal Petition for Rulemaking to the Consumer Product Safety Commission, asking for a regulation to ban all consumer products in four categories (children products, furniture, mattresses and mattress pads, and plastic electronics enclosures) if the product contains any organohalogen flame retardant. We have picked these product categories because organohalogen flame retardants are used extensively in these products and are known to migrate from the products leading to human exposures, despite the strong evidence that all halogenated flame retardants pose serious health concerns. We have worked extensively with Eve Gartner at EarthJustice on the legal aspects of the Petition. We have supporting statements from many preeminent scientists and doctors on health risks, exposure scenarios, and so on. We have also asked the Consumer Federation of America to join the legal team as co-counsel because of their expertise in working with CPSC.

January 8, 2015—The Green Science Policy Institute is preparing a Legal Petition for Rulemaking to the Consumer Product Safety Commission, asking for a regulation to ban all consumer products in four categories (children’s products, furniture, mattresses and mattress pads, and plastic electronics enclosures) if the product contains any organohalogen flame retardant. These product categories have been picked because organohalogen flame retardants are used extensively in these products and are known to migrate from the products leading to human exposures, despite the strong evidence that all halogenated flame retardants pose serious health concerns. Children are particularly harmed — from prenatal exposures being linked to neurodevelopmental deficits, lowered IQ, autism, and other serious health impacts, to the fact that children have been found to have higher body burdens of flame retardants than adults.

January 12, 2015—As a member of the Patient, Consumer, and Public Health coalition of the National Center for Health Research and enthusiastic supporters of the Affordable Care Act, we thank Minority Leader Pelosi for championing that legislation and for all the efforts to protect it from efforts to undermine it. We are writing to ask her to vigorously defend the 2.3% excise tax on medical devices because it provides essential funding for the ACA. The comparison of stock prices on the day the law went into effect and on its two-year anniversary indicate, that stock prices for the 12 companies increased by 6% to 126% with an average increase of 66%. Medical device makers strongly outperformed the New York Stock Exchange Composite Index, which increased by 25% during that same period, and NASDAQ, which increased 52%. The device company stocks increased even more than stocks in the top US-based pharmaceutical companies, which increased 54% during the same two years. Over the last decade, profit margins for the 12 largest device companies averaged between 9-17% (except for 1% in 2009), and the most recently reported 12-month profit margins averaged above 15%. Approximately 10 million Americans have obtained health insurance through the ACA and millions more through Medicaid expansion. This benefits medical device manufacturers because patients no longer have to wait for years to be able to afford diagnostic tests, joint replacements, cardiac surgery, and other treatments that involve devices. Levies in the ACA were designed to ensure that the companies that are benefiting from the ACA will do their part to help support it. The medical device tax is no exception. According to the Joint Committee on Taxation, repealing the excise tax on medical devices would cost more than $29 billion over 10 years, which would damage ACA’s fiscal integrity. Repeal or reduction would also set a terrible precedent that could encourage others to undo crucial funding provisions in the ACA.

January 19, 2015—AMWA was asked to sign onto a letter produced by Physicians for Reproductive Health (PRH) to oppose H.R. 36 (a ban on abortion at 20 weeks) which is scheduled for a floor vote in the U.S. House next Thursday. PRH has updated a letter for provider organizations to sign in opposition to the bill. AMWA signed onto the letter in the last Congress and will sign onto this one for the present Congress

February 3, 2015—AMWA as a member of the Patient, Consumer, and Public Health Coalition appreciates the opportunity to provide feedback regarding the Food and Drug Administration’s plan to regulate laboratory developed tests (LDTs). We thank the Food and Drug Administration for its stakeholder engagement on this topic, including convening a public workshop and its release of this draft guidance document. We strongly support FDA’s efforts to regulate laboratory developed tests (LDTs). Some in the industry do not want FDA to regulate LDTs but rather for the tests to be under Centers for Medicare & Medicaid Services (CMS) authority. There’s a big problem with that–CMS does not address the clinical validity (accuracy) of any test.
Faulty tests will erode the confidence of physicians and patients. Requiring FDA review prior to going on the market and adverse event reporting afterwards will give patients and providers the information they need to make informed decisions.
CLIA Cannot Substitute for FDA Assurance of Safety and Effectiveness
As stated by the Centers for Medicare & Medicaid Services (CMS), “CMS’ CLIA program does not address the clinical validity of any test – that is, the accuracy with which the test identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient.”[1] In contrast, the FDA evaluates the clinical validity of a test under its premarket [DZ1] approval process as well as through post-market surveillance. Because of that expertise, the FDA PMA process can determine clinical validity, whereas CLIA does not. Clinical validity is essential to understanding the overall risks and benefits of any test. We strongly urge that tests used to diagnose or determine treatment for cancer and other potentially life-threatening diseases be regulated through the PMA process [DZ2] .
Users of high-risk LDTs should be afforded the same protections as other IVD users
Some LDTs make claims similar to those of FDA-approved in vitro diagnostics (IVDs), and may be equally high-risk. We agree with the FDA’s concern that most patients and physicians are not aware of which IVDs have been reviewed by the FDA, and which have not. Under the current system, patients who use LDTs could therefore be exposed to more risk than patients using FDA-approved IVDs. One regulatory standard for all IVDs, including LDTs, will ensure that all patients using IVDs have the same level of protection.
Addresses gap in regulation acknowledged by sister federal agencies and medical societies
Several federal agencies, including the Centers for Medicare and Medicaid Services (CMS) and the National Human Genome Research Institute (NHGRI), have expressed support for this effort. NHGRI has stated that whereas CMS “does regulate clinical laboratories, it does not examine whether the tests performed are clinically meaningful. Since the 1990s, expert panels and members of Congress have expressed concern about this regulatory gap and the need for FDA to address it.”[2] CMS points out that “the FDA’s analytical validity review is more in-depth and more comprehensive than that of the CLIA program, and it is focused on the test system’s safety and effectiveness. As a result, FDA review may uncover errors in test design or other problems with a test system.”[3] The American Society of Clinical Oncologists has also expressed their support, stating that “a patient’s treatment options are increasingly driven by detection of molecular abnormalities in the tumor that drive treatment selection. ASCO believes that the tests used to detect those abnormalities must be of the highest quality and thoroughly validated before being offered to doctors and patients.”[4] FDA and CMS Oversight Are Distinct
Critics of the FDA’s plan to regulate LDTs have stated that regulation of LDTs by both FDA and CMS will be redundant. We disagree, as in CMS’ own words, “the two agencies’ regulatory schemes are different in focus, scope and purpose, but they are intended to be complementary.”1 We applaud FDA and CMS for their partnership in assuring that LDTs are held to the highest standards, and recognize the unique role that each agency plays in accomplishing this goal.
Transparency Will Increase Physician and Patient Confident in LDTs and Encourage Better Science
Faulty tests will erode the confidence of physicians and patients. Requiring FDA review prior to going on the market and adverse event reporting afterwards will give patients and providers the information they need to make informed decisions. As non-LDT in vitro diagnostics (IVDs) are already under FDA regulation, using the same regulatory processes will encourage higher quality science, stimulating, not hampering, true innovation.
Use of LDTs has changed dramatically since 1976
The guidance details the evolution of LDTs since 1976, when FDA decided to exercise enforcement discretion regarding LDTs. LDTs are now widespread and used in high-risk medical circumstances. The FDA describes how, in 1976, “LDTs were typically used and interpreted directly by physicians and pathologists working within a single institution that was responsible for the patient.” This has clearly changed over the last four decades; we agree that “LDTs are often used in laboratories that are independent of the healthcare delivery entity.”[5] Opponents of FDA regulation of LDTs argue that LDTs fall within the practice of medicine, and therefore outside of FDA’s jurisdiction. This argument clearly does not apply to the situation today, where the prescribing physician and patient are often physically separated from the laboratory conducting and interpreting the LDT, and the laboratory is not responsible for the patient’s care.
FDA Plan follows risk-based, phased-in approach to ensure efficient process
The laboratory industry has expressed concern over meeting the requirements of FDA regulation. However, the guidance lays out a risk-based, phased-in approach which will proceed over several years.[6] This approach allows ample time for laboratories to come into compliance and will also ensure that the highest risk devices are regulated as quickly as possible. We strongly urge the FDA to ensure that high-risk LDTs are classified as class III devices and are reviewed through the PMA process. The benefits of FDA’s regulation of LDTs will hinge on classifications that clearly reflect a device’s benefits when it is accurate and risks when it is not.
Expertise and Risks of Third Party Reviewers
Critics have also suggested that FDA lacks the expertise and resources to regulate LDTs in a timely and efficient manner. However, the guidance clearly states that the FDA will make use of the expert advisory panels and certified third-party organizations where appropriate for risk classifications and review of non-high risk devices.[7] We have very strong concerns about the use of third party organizations and entities, because of the difficulty of preventing conflicts of interest that would introduce bias into the process. We strongly urge that the FDA reduce the use of such entities as the FDA’s role is phased in and as the expertise of FDA scientists is strengthened.
Conclusions
The National Institutes of Health Director, Dr. Francis Collins, in response to release of the pre-draft guidance, stated that “this is good news for all who are working to turn the dream of personalized medicine into a reality.”[8] We agree. To strengthen the guidance, we urge the FDA to ensure Class III designations for high-risk tests and introduce the safeguards needed to prevent conflicts of interest for involved third parties. To continue its efforts to protect patients who rely on LDTs to guide critical medical decisions, we also urge the FDA to release a final guidance in a timely manner.
National Center for Health Research
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202)223-4000 or at pb@center4research.org
February 3, 2015—As a member of the Patient, Consumer, and Public Health Coalition, AMWA is writing to the Senators to express our strong opposition to the PATH Act (S 185) that was introduced by Senators Hatch and Bennet, and to urge you to not support it. We are all concerned about antibiotic resistance and want to find ways to reduce it and ensure that patients will continue to have access to effective, life-saving antibiotics. Supporters of the PATH Act state that is their goal, but the bill includes numerous provisions that would be very dangerous to patients across the country. The purpose of the bill is described as creating a limited population pathway for approval of certain antibacterial drugs. The bill states that upon determining that a drug is intended to treat a serious or life-threatening disease, condition, or infection and address an unmet medical need for a small population of patients, FDA would approve it based on what would normally be considered very inadequate evidence. One example would be to rely on “pre-clinical data,” which are data collected prior to studying the drug on any patients. While some might argue that this risk is acceptable if the patient is dying anyway and there is no other treatment, the problem with this bill is that doctors would have the authority to prescribe the drug for any patient, regardless of whether the patient has a serious condition and regardless of whether safer alternatives exist. FDA does not have the authority to restrict the practice of medicine, so an FDA pathway that lowers standards in this way puts millions of patients at risk. Research shows that lowering the approval standards does not serve as an effective incentive for companies to develop new drugs.[iii] And, when patients are eager to opt for experimental therapies it is possible under existing humanitarian access programs. Moreover, by allowing companies to conduct studies on very small numbers of patients, or rely on information gathered before patients were even studied, The PATH Act would undermine Congressional efforts to ensure that new drugs are carefully tested on women, men, people of color, and people over 55, to make sure that they work for all Americans. Since the PATH Act provides the FDA with only 30 days to approve marketing materials, many unproven drugs approved through the PATH pathway would be widely advertised to patients and their doctors who do not realize the drugs are not proven safe or effective. It is well known that the FDA lacks the resources to carefully review promotional materials in such a short time frame, and even if given a longer time would be unable to effectively monitor online marketing.
In 2012, Congress passed the FDA Safety and Innovation Act (FDASIA), which included a provision that provides a fast track and financial incentives that make it easier and more lucrative for companies to develop new antibiotics. At the time, sponsors of this legislation said it would be very effective and solving the problem of antibiotic resistance. We haven’t had time to find out if that law is working, so reducing standards further and adding more incentives is very premature. Applying lower standards for all drugs, including those that are not aimed at an unmet need, should be unacceptable to any Senator who values the health of their constituents. Legislation is needed to reduce antibiotic resistance, but neither PATH nor ADAPT is the answer. Both bills are likely to do more harm than good to your constituents. Members of the Patient, Consumer, and Public Health coalition would like to set up a time to talk to you about this bill at your convenience.

February 25, 2015—There is a move to make ketamine a scheduled drug due to its abuse in the West. This would have marked deleterious effect on physicians’ ability to conduct caesarian sections in low resource settings. The information we have to consider suggests signing the appeal and making a press statement against scheduling ketamine. It would also be good to ask our members to sign under other interested vested associations. This is an important issue for reducing maternal and perinatal mortality in developing countries and will be enthusiastically championed by AMWA and MWIA.

February 27, 2015—Dr. Diane Helentjaris went to this on behalf of AMWA Friday, February 27. The event was basically a celebratory “thank you” to all HHS staff and partners who have helped roll out and implement the ACA.

There appeared to be a couple hundred people there. President Obama’s Chief of Staff, HHS Secretary Burwell, the head of OPM and the Small Business head all spoke – giving a positive message about the difference access to healthcare has already made in people’s lives and its potential to do even more – not only for those seeking healthcare but also, for example, for small business owners who can now have their employees covered.

Marilyn Tavenner, Administrator for the Centers for Medicare and Medicaid was there with Aryana Khalid, her Chief of Staff. Dr. Helentjaris knew both of them from her work with the Virginia Department of Health – Marilyn was Virginia’s Sec of Health & Human Services and Aryana worked in health policy. She spoke with them, letting them know she was representing AMWA. (It was apparently Marilyn’s last day as she announced she was leaving in Feb. Aryana is leaving this month.)

Dr. Helentjaris also met a woman pharmacist who does policy work for the National Association of Chain Drug Stores. Her contact info will be forwarded if she sends it as promised.

March 11, 2015—Dr. Diane Helentjaris attended this HHS meeting on behalf of AMWA. Basically, a private company (Cord Blood Registry) gave a nice informative presentation on the current status of and issues surrounding cord blood banking and usage. There is some upcoming legislation but this was not a call for help with that (it is usually not problematic though funding is typically less than what is requested and less than what is needed). Here’s a possible blurb for members, based on the talk and written literature:
Newborn stem cells and cord blood, banked through both private and public entities, is an important women’s health issue. This tool is currently used in transplant medicine to replace affected cells and treat blood cancers and solid tumors, immune disorders, metabolic disorders and genetic diseases. Research is now looking into its use to restore new cells for such diseases and conditions as autism, brain injury, diabetes and spinal cord injuries. In 2005 the Institute of Medicine issue]d a report to Congress on cord blood banking, recommending that expectant parents receive balanced education about cord blood preservation. Unfortunately, there continues to be a need for both professional and parental education about this important health tool. Legislation was initially passed in 2005 and 2010 to support cord blood education. The Stem Cell Act is up for reauthorization this year Currently 29 states have passed cord blood education legislation and others are developing such legislation.
Free online CME education, supported by the Cord Blood Registry (a private company) is available at www.OmniaEducation.com/CordBlood. Information targeting expectant families is provided by the Parent’s Guide to Cord Blood Foundation which was founded by Frances Verter, Ph.D., a Princeton-educated astrophysicist who lost her child to cancer. Contact information is info@parentsguidecordblood.org or ParentsGuideCordBlood.org, 23110 Georgia Avenue, Brookeville, MD 20833.

March 11, 2015—In January, members of the Patient, Consumer, and Public Health coalition of which AMWA is a member sent Paul Pallone, the ranking member of the House Energy and Commerce Committee a letter asking that he vigorously defend the 2.3% excise tax on medical devices by opposing H.R. 160. The excise tax is a key provision of the Affordable Care Act and is providing a significant source of revenues.

Opponents of the tax claim that the medical device industry has suffered as a result of the tax, which went into effect in January 2013. However, the most recent evidence, some of which became available in the last week, clearly contradicts that claim.

We have attached a newly updated report by the National Center for Health Research (NCHR),which analyzes the stock prices, profits, sales, and R&D spending of the 12 largest U.S.-based medical device companies[1] and a half dozen of AdvaMed’s smallest medical device companies.[2] Only companies that primarily or exclusively make medical devices were included.

The analysis shows that the medical device companies are doing very well compared to pharmaceutical companies and most other industries. Stocks are way up (66% for the largest companies and even higher for the smallest companies), sales are up, R&D spending has steadily increased, and profit margins are very high. There is no evidence that the device tax had a negative impact.

Despite industry’s claims to the contrary, The Washington Post Fact Checker reported earlier this year that device companies are doing well. Editorials in The New York Times, USA Today, and The Washington Post all support retaining the excise tax on medical devices. The New York Times points out that the device industry is contributing much less than “insurers and drug companies, all of which will benefit from increased business under the act and should pay their fair share of the costs.”[3]

According to the Joint Committee on Taxation, repealing the excise tax on medical devices would cost more than $29 billion over 10 years.[4] In addition to adding to the deficit, this would set a terrible precedent that could encourage others to try even harder to undo crucial funding provisions in the ACA.

As the attached updated analysis shows, the medical device industry is highly profitable and has continued to thrive since the excise tax was implemented. The Congressional Research Service notes that the device tax has not harmed companies or the cost of health care.[5] Meanwhile, the cost of health care increased less from 2013 to 2014 than it has in the past 10 years.[6]

Fortunately, Congress designed the excise tax to apply equally to imported and domestically produced devices, and does not apply to devices produced in the U.S. for export, so there would be no benefit for manufacturers to shift production overseas.

A repeal of the medical device excise tax would be unacceptable to those of us who strongly support the Affordable Care Act. We do not, however, have the lobbying resources of the medical device industry, which has spent more than $150 million in lobbying to repeal the tax.[7] Please don’t let those special interests undermine that groundbreaking legislation!

Thank you for your strong leadership that has improved the health of all Americans. Please do everything possible to oppose H.R. 160 and any other efforts to repeal the excise tax on medical devices.

March 11, 2015—AMWA signed onto to the Patient, Consumer, and Public Health Coalition’s comments regarding the Consumer Product Safety Commission’s proposed rule on phthalates. We strongly support the proposed rule (it’s not perfect but it’s very good). Industry opposes the proposed rule. We had a big victory back in 2008 when some chemicals (known as phthalates) used to make plastics soft and pliable were banned from certain children’s toys and childcare products. This proposed rule will add to that victory.

March 11, 2015—AMWA opposed a bill known as PATH—the “Promise for Antibiotics and Therapeutics for Health Act.” PATH aims to shorten the approval process not only for antibiotics but also for virtually any other drugs that might be used in life-threatening diseases. As written, the bill presents a new fast-track pathway for FDA drug approval based on data from animals, test tubes, and mathematical modeling instead of clinical trials in humans with diseases. This will result in new drugs which are ineffective and unsafe for our patients while actually adding to antibiotic resistance and fostering the growth of “superbugs.” (For those concerned that such bills are needed for our truly sick ICU patients, the FDA is currently already working to greatly shorten the paperwork needed to gain access to investigational drugs for compassionate uses.) AM WA members were urged to contact their Senators as soon as possible.

March 16, 2015—Many times state bills are forerunners to the national scene especially in California, therefore, AMWA is supporting a CaliforniaHealth 4 All bill, which is seeking to provide healthcare to all folks regardless of immigration status. As advocates, we know that access to health insurance is critical in order to promote the reproductive and overall health of immigrant women. Comprehensive health coverage is essential as a woman’s reproductive health is not isolated from other aspects of her well-being. Passing legislation that truly expands health coverage to every Californian will address one of the most unjust challenges immigrant women face to improve their reproductive and overall health. Approximately 47% of undocumented Californians are women. Moreover, immigrant women tend to be concentrated in low-wage and/or part-time jobs that do not offer health coverage at all or offer coverage that is too costly. AMWA will distribute the sign-on letter in its newsletter.

March 16, 2015—As an addendum to the February 25, 2015 entry above on Ketamine, we have had some progress: On March 13, the Commission on Narcotic Drugs discussed the possible bringing of ketamine under international drug control. Initially, China proposed to add the substance under Schedule I of the UN Convention on Psychotropic Substances. Such a scheduling means that the substance can be used for medical purposes only under direct governmental supervision, and in very limited situations. The proposal was very inappropriate for an essential medicine. However, thanks to the efforts of many, China amended its proposal to the less strict Schedule IV of the same convention. Again we opposed this and thanks to our opposition, China withdrew this morning its entire proposal. The CND then decided to postpone its decision on scheduling ketamine to a future date to allow more information to be gathered. A transcript of the debate is available here: http://www.cndblog.org/2015/03/agenda-item-6b-change-in-scope-of.html#more This is a very good result.

March 31, 2015—Last year, 17 members of our Coalition, which includes patients, consumer advocates, scientists, and physicians, submitted comments to the FDA strongly supporting its proposed rule on generic drug labeling.

The proposed rule would allow generic drug manufacturers to update their labeling as new information becomes available. Patients and consumers deserve up-to-date information about the prescription drugs that they use. It is essential that all prescription drugs (not just brand named drugs) carry accurate safety warnings, and all manufacturers remain attentive to potential health hazards. We now strongly urge the FDA to adopt the rule.

March 31, 2015—The Coalition strongly supports most provisions of the proposed rule on the “Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates.” However, we are disappointed with some of the provisions described and strongly disagree with the CPSC regarding DIOP. In the final rule we recommend that the CPSC protect the health of consumers by permanently banning DIOP.

March 31, 2015—AMWA supported Senators Barbara Boxer and Patty Murphy to introduce the 21st Century Women’s Health Act. This important bill would guarantee that more women across our country will have access to the reproductive-health care they need. To pass this bill, the help of NARAL members is needed to convince Congress that the pro-woman majority won’t be silenced. No more defense. Together, we’re going on offense. Together, we can pass this bill if we show our strength.

March 31, 2015—As members of the Patient, Consumer, and Public Health Coalition we support the draft guidance “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” with one suggested revision to Section V to help in clarifying who currently holds a 510(k) device. Overall, this guidance will help to ensure that the public information in the FDA’s 510(k) databases are accurate and up-to-date, including the most current owner of a 510(k) device.
March 31, 2015—On March 19th, Representative Michael C. Burgess, M.D. (R-TX) and Senate Finance Committee Chairman Orrin Hatch (R-UT) unveiled a bipartisan plan to repeal and replace the sustainable growth rate (SGR) physician payment system for physician reimbursement under Medicare. The plan includes a 2-year extension of the Children’s Health Insurance Program (CHIP) and funds community health clinics (CHC’s). This broader plan builds upon the SGR Repeal and Medicare Provider Payment Modernization Act, H.R. 1470, and is known as SGR. NLIRH became aware of leadership intent to add Hyde Amendment language into the provision governing CHC’s. While we have not had access to the language, NWLC was able to review the provision and send us some analysis.

April 5, 2015—Dr. Silva reviewed the Dietary Guidelines 2015 for the Distilled Spirits Council of the United States which includes those for alcohol and suggested that a separate section for alcohol would be preferable as had been done in prior years. Also, critical definitions (heavy drinking and binge drinking) were missing from the scientific report and we would like to make sure that these will be included in the policy document.
April 7, 2015—AMWA signed onto the Statement of the Coalition to Protect the Patient-Provider Relationship,* and Other Medical, Health and Advocacy Groups Regarding Mandating Health Care Professionals Provide Unsubstantiated Medical Information. We express serious concern about an increasing number of governmental actions that inappropriately interfere in the relationship between patients and their health care providers by requiring health care professionals to violate their medical training and ethical obligation to their patients. We urge states to exercise caution and restraint to safeguard this important relationship. We believe that all parties speaking to the provision of health care should respect the unique nature of the patient-provider relationship and support the ethical obligation of the health care provider to deliver individualized, evidence-based care and put the patient first. This past week, the state of Arizona mandated that medical professionals providing abortion care tell their patients that medication abortion may be reversible – a claim wholly unsubstantiated by any reliable evidence, with no basis in medical science. This mandate is emblematic of a larger trend of lawmakers abusing their regulatory responsibilities by imposing ideological views on licensed and highly trained health care professionals.

We urge all legislatures to ensure that laws adhere to the following principles to protect the patient-provider relationship:

1. Providers should not be prohibited by law or regulation from discussing with, or asking their patients about, risk factors that evidence shows may negatively impact their health, or from disclosing clinically relevant information to patients.

2. The information and care provided should be consistent with the best available medical evidence on clinical effectiveness and appropriateness and professional standards of care.

3. The information and care should be tailored to individual patient circumstances and allow for flexibility as to the most appropriate time, setting and means of delivering information and care, as determined by the provider and patient.

4. The information and care provided should facilitate shared decision-making between patients and their providers, based on the best medical evidence, the provider’s knowledge and clinical judgment, and patient values, beliefs, and preferences.

We hope we can all agree that health care providers should not be forced to choose between their professional and ethical obligation to provide evidence-based, high-quality care and following misguided laws, and patients should not receive care that has no medical basis or is inappropriate to their circumstances.

April 13, 2015— AMWA signed onto the Planned Parenthood’s petition to oppose an education bill the House previously attempted to move H.R. 5 which was a restriction on the health information school based health centers can provide as part of the manager’s amendment. Given that we are likely to see action in the next work period, Planned Parenthood and the School Based Health Alliance have prepared a coalition sign-on letter. The letter urges Members of Congress to oppose any effort to interfere in the relationship between students and health care providers by limiting access to information or health care services in any reauthorization of the Elementary and Secondary Education Act (ESEA). On February 26th, 2015, during consideration of H.R. 5, the Student Success Act, which would reauthorize ESEA, a politically motivated amendment was added to the Manager’s Amendment that would limit young women’s access to information about abortion. The amendment was a misguided attempt to ban school-based health centers from sharing age-appropriate, medically accurate information about the full range of reproductive health care options, including abortion. In addition to the language included in the managers’ amendment, a misguided amendment was submitted to the rules committee that would have prohibited federal funds from going to any school that provides emergency contraception, or a prescription for it, on the premises
As the nation’s leading medical and public health organizations, it is vital that we stand in strong opposition to efforts to curtail young people access to accurate health information and care.

April 13, 2015—AMWA signed onto the National Research Center’s coalition letter to express our concern about the lack of diversity and sufficient safety data in the clinical trial data discussed at a recent advisory committee meeting for the review of an asthma product, Breo Ellipta. Long-acting beta-agonists (LABAs) like Breo Ellipta have a history of serious adverse events in asthma patients, including a four-fold increase in asthma-related death. The data presented by GlaxoSmithKline indicates that Breo Ellipta has a similar safety profile to other combination Inhaled Corticosteroid/long-acting beta-agonists. The sponsor submitted pooled analysis from 18 clinical trials for safety information. However, only five of these trials had relevant treatment and control arms and two of those trials were only 12-week studies (less than half the 26 weeks of clinical trials required for previous LABAs). Moreover, there were only 3,100 patients across the three studies that were examined for least 26 weeks long (significantly less than the more than 25,000 patients included in safety trials for one of the other approved LABAs, Salmeterol). The sponsor submitted pooled analysis from 18 clinical trials for safety information. However, only five of these trials had relevant treatment and control arms and two of those trials were only 12-week studies (less than half the 26 weeks of clinical trials required for previous LABAs). Moreover, there were only 3,100 patients across the three studies that were examined for least 26 weeks long (significantly less than the more than 25,000 patients included in safety trials for one of the other approved LABAs, Salmeterol). More appropriate safety and efficacy trials should be conducted before approval. We urge the FDA to require pre-approval studies lasting at least 26 weeks (the same standards as other LABAs) and that are sufficiently powered to examine subgroups such as 12-17 year olds and African Americans for both safety and efficacy.
April 20, 2015—AMWA signed onto a letter to Reps. Cooper and Lummis to offer our endorsement for the Research for All Act of 2015 (same as 2014). We believe this legislation will improve our knowledge of women’s inclusion in medical research by updating reports on women and minority inclusion in medical research at the National Institutes of Health (NIH) and Food and Drug Administration (FDA). It will also expand our understanding of sex differences in both basic and clinical research at the NIH, and direct the FDA to guarantee that clinical drug trials for expedited drug products are sufficient to determine safety and effectiveness for both men and women.
April 20, 2015—AMWA signed onto the Coalition of the National Center for Health Research to once again support the FDA’s Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products when it was released in 2014, and we strongly support the rule moving forward expeditiously through the regulatory approval process now in 2015.

Requiring all prescription drugs to carry up-to-date safety warnings is essential for improving the safety and efficacy of all FDA approved drugs as well as for shoring up needed consumer safeguards and protections. This new rule will enable generic drug manufacturers to revise drug labeling through the changes-being-effected (CBE-0) process, which currently permits brand-name manufacturers to update product labeling subject to simultaneous (instead of prior) review by the FDA. Extending this process to generic drug manufacturers will give physicians, patients, and their family members access to better and more accurate information about the risks and benefits of the medications they are taking, regardless of whether a drug is brand-name or generic.
Eleanor Holmes Norton supports this act as is expressed below:
You are receiving this letter because you recently wrote to Eleanor Holmes Norton.

April 17, 2015
Omega Silva
354 N Street, SW
Washington, DC 20024-2904

Dear Dr. Silva:
Thank you for contacting me regarding H.R. 931, the Helping Effective Antibiotics Last Act. I very much appreciate hearing from you.
I am a cosponsor of H.R. 931. Like you, I am very concerned about the increasing threat of antibiotic resistance. I will continue to work with my colleagues in the House and Senate to pass the bill.
Please continue to keep me informed of your views on legislation and other congressional issues. I also invite you to contact me whenever you have a federal issue or a problem with which you think I can be helpful. I hope you visit my website at www.norton.house.gov and sign up for my weekly newsletter, where I report the earliest information on what I am doing in Congress. I hope you will also follow me on Facebook and Twitter. Please also note that our constituent services office has moved to the front entrance of a new building at 90 K Street NE.

Sincerely,

Eleanor Holmes Norton
Member of Congress
April 27, 2015—AMWA signed onto the National Center for Health Research’s letter to the U. S. Department of Health and Human Services (HHS) which is seeking nominations for consumer/patient representatives to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. The Coalition wishes to nominate Jeanine Thomas, President of the MRSA Survivors Network and John Powers, MD, Senior Medical Scientists at NIH. Both are experts on AB resistance and would be very competent representatives for our coalition’s views on the need to safeguard the efficacy of all antibiotics by preventing overuse, and the need to carefully test new ones to make sure that they are approved for patients who are most likely to benefit and least likely to be harmed. The advisory council (AC) will have up to 30 members. AMWA sent a letter on our stationery as well.
May 4, 2015—The Coalition for Abortion Access & Reproductive Equity (CAARE) of which AMWA is a member is continuing to work to remove abortion restriction riders in the Appropriations process. Almost 60 organizations signed on to the letters we distributed last year to draw attention to this effort, and we want to surpass that number this year. We hope that you will add your voice and demonstrate support for lifting restrictions on coverage of abortion care! We are circulating two letters this year:
1. Letter to Senators Cochran and Mikulski, Chair and Ranking Member of the Senate Committee on Appropriations, on all policy riders that restrict funding for abortion coverage. 2. Letter to Representatives Rogers and Lowey, Chair and Ranking Member of the House Committee on Appropriations, on all policy riders that restrict funding for abortion coverage. AMWA filled-out the form to sign us-up for this action.

May 14, 2015—AMWA signed onto policies to help mitigate the rate of firearm injuries and deaths in the U.S. announced by the American College of Physicians, 7 other national health professional organizations, and the American Bar Association in a paper published in the Annals of Internal Medicine in February 2015. The organizations support a public health approach to reducing firearm injuries and fatalities, similar to approaches used to reduce tobacco use, motor vehicle fatalities, and unintentional poisoning. The paper recommends ways to reduce firearm-related injuries and death:
-Support criminal background checks for all firearm purchases, including sales by gun dealers, sales at gun shows, and private sales from one person to another;
-Oppose state and federal mandates that interfere with physician free speech and the patient-physician relationship, including physician “gag laws” that forbid physicians to discuss a patient’s gun ownership;
-Oppose the sale or ownership of “assault weapons” and large-capacity magazines for private citizens; and
-Advocate for research into the causes and consequences of firearm violence and unintentional injuries so that evidence-based policies may be developed.
The American Bar Association notes in the paper that these recommendations “are constitutionally sound.” The health professional societies made 2 additional recommendations:
-Support improved access to mental health care, with caution against broadly including all persons with any mental or substance use disorder in a category of persons prohibited from purchasing firearms; and –
Oppose blanket reporting laws that require physicians to report patients who are displaying signs that they may cause serious harm to themselves or others, as these laws may stigmatize patients with mental or substance-abuse use disorders and inhibit them from seeking treatment.
ACP was joined by the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Emergency Physicians, the American Congress of Obstetricians and Gynecologists, the American College of Surgeons, the American Psychiatric Association, and the American Public Health Association, as well as the American Bar Association in its call to action.

May 18, 2015—As a member of the Patient, Consumer, and Public Health Coalition, AMWA is joining to write to express our strong concerns about the 21st Century Cures legislation. At the recent E&C Subcommittee on Health markup of the 21st Century Cures Act, Committee Ranking Member Frank Pallone stated that the Act was “far from a finished product,” and the Health Subcommittee Ranking Member Gene Green said there is “still work to do.” We agree. Several sections of the Act would lower standards for the approval of antibiotics, medical devices, and most prescription drugs – putting patients at unnecessary risk of injury or death. A few of our specific concerns are below.
If these provisions are fixed in Committee, we will be able to support the Bill. But as currently written, the FDA provisions of 21st Century Cures violates the basic tenet of medical care–“First, do no harm.” The FDA provisions are more geared toward helping industry than helping patients. Patients deserve an FDA that keeps unsafe and ineffective pharmaceuticals and medical devices (including software) off the market by evaluating their risks and benefits as carefully as possible, in addition to as quickly as possible. These revisions are necessary to provide those safeguards for all patients. The bill further erodes FDA standards by allowing drug companies to submit short summaries about the safety and effectiveness of already approved drugs, instead of providing actual evidence to support what is stated in the summaries. This would apply to new indications, even when drugs were approved in expedited pathways
Even more egregious, the bill states that “nothing in this section prohibits the Secretary from using evidence from clinical experience for purposes not specified in based on preliminary, inconclusive data in this section,” which suggests clinical experience could possibly be used as evidence to support FDA approval for new medical products as well. Overall, the wording of these sections is so vague that it could eviscerate the FDA’s ability to make informed judgments about the safety or effectiveness of any drug, device, or vaccine.
This section would create a new pathway for approving antimicrobials that would discourage the use of large, well-designed, randomized, controlled clinical trials, which are the gold standard for assessing safety and effectiveness. Instead, the proposed pathway would force the FDA to enter into a written agreement early in the clinical development program that would allow approvals based on preliminary, uncontrolled clinical studies alone. The drugs would be tested on small numbers of patients (a limited population) but could then be prescribed for all patients without clear evidence that it is beneficial for all patients. That would be harmful to patients.
This section would create a new pathway for approving antimicrobials that would discourage the use of large, well-designed, randomized, controlled clinical trials, which are the gold standard for assessing safety and effectiveness. Instead, the proposed pathway would force the FDA to enter into a written agreement early in the clinical development program that would allow approvals based on preliminary, uncontrolled clinical studies alone. The drugs would be tested on small numbers of patients (a limited population) but could then be prescribed for all patients without clear evidence that it is beneficial for all patients. That would be harmful to patients.
It is important to note that while antibiotic resistance is a public health problem that is related to the lack of financial incentives to develop new antibiotics, the issues are different for antifungals. If Congress lowers the standards for antifungals as described in this provision that would be very harmful to patients without providing a benefit.
No peer-reviewed journals scrutinize the accuracy of the data submitted; they only review the interpretation of the data provided. In contrast, the FDA has access to the complete trial protocols and datasets, can inspect clinical trial sites to monitor trial conduct, and often re-analyzes data to determine its accuracy. Moreover, some peer-reviewed medical journals have a track record of publishing anything that is submitted. In addition to their questionable accuracy, peer reviewed studies would not necessarily include women, racial and ethnic minorities, people over 65, or children.
This section defines “health software” and exempts it from FDA regulation. The proposed definition of “health software” includes Electronic Health and Medical Records (EHRs and EMRs) (under Section 2241(1)(C)) and software which guides treatment decisions by physicians (under Section 2241(1)(F)). This puts patients at risk, because if this software is inaccurate, patients can be harmed just as they would by other types of medical devices.
The bill states that the FDA could regain the ability to regulate software which guides treatment decisions by physicians (Section 2241(1)(F)) under narrow circumstances. We disagree that health software should be exempt from FDA regulation. However, if it is exempted in this bill, the process for regaining regulatory authority needs to be clearly described and should not be burdensome to the agency. In addition, EHRs and EMRs (defined under Section 2241(1) (C)) should be added to the type of software FDA could regain the ability to regulate.
June 2, 2015—AMWA signed onto The Commission to End Health Care Disparities (the Commission) and the recommendations offered are based on the report, which was adopted by the Commission and published in 2011, entitled Collecting and Using Race, Ethnicity and Language Data in Ambulatory Settings: A White Paper with Recommendations. We write to provide input into the Office of the National Coordinator for Health Information Technology Notice of Proposed Rulemaking for 2015 Health Information Technology Certification Criteria regarding race, ethnicity, preferred language, gender identity, sexual orientation, disability, and social and behavioral factors data collection. HIT should support accurate demographic data collection, a facilitated display of performance data, and two-click access to displays of performance data stratified by any key demographic group. We appreciate the opportunity to offer these suggestions and stand ready to assist in your important work.

June 2, 2015—AMWA as a member of the Patient, Consumer, and Public Health Coalition, which includes organizations representing patients, consumers, health professionals, and scientists, has admired Rep. Lois Capp’s work on behalf of improving the quality of public health. We, as part of the coalition read her May 14, 2015 statement of support for the 21st Century Cures Act, stating that it would result in more children and seniors in clinical trials. However, the coalition’s analysis of the bill finds that it suggests but does not require the changes needed to ensure their inclusion in clinical trials. And, unfortunately, there are several provisions in the bill that would have the opposite effect. Like you, Rep. Capps we are glad that there is language included in H.R. 6 (21st Century Cures Act, Section 1083) that calls for the National Institutes of Health Director to convene a workshop of experts on pediatric and geriatrics, provide guidelines, and make the findings of the workshop publicly available. However, the language does not mandate that more children and seniors will be included in clinical research, nor is there specific language anywhere in the bill that would do so. We encourage you to take a leadership role on this issue by including an amendment to the 21st Century Cures Act when it reaches the full House floor that would require that clinical trials include sufficient numbers of pediatric and patients over 65 in clinical research, including trials used as the basis of FDA approval decisions. The Coalition would welcome the opportunity to work with your staff on such an amendment

June 2, 2015—As long-time supporters of women’s health and safety, The National Women’s Network is once again writing to Congresspersons to thank them for their continuous support for the Food and Drug Administration’s (FDA) stringent, evidence-based drug review process. You may be aware that a company seeking approval for a new drug to treat female sexual desire disorder is claiming that the FDA has displayed gender bias in its evaluation of the drug. We would like you to understand the perspective of the undersigned organizations, all of which have long and extensive experience advocating for women’s health at the FDA. We are concerned about the safety and efficacy of this drug, flibanserin, and believe that women’s health will be best served if the FDA is allowed to do its job of carefully weighing the evidence. As a Network we wrote to the FDA in March 2014 and again in May 2014 as we now do to support the FDA’s concern for drug safety shown in what we believe is its appropriate handling of the flibanserin applications by rejecting its approval. We also appreciate your longstanding support for women’s health and safety. Even the Score’s effort to make this a conversation about gender equality is misleading and dangerous. The FDA should continue to balance a serious and respectful incorporation of patient input while maintaining a rigorous, science-based review standard for the drugs and devices it approves. We again agree with the disapproval of Flibanserin for the reasons FDA stated.

June 9, 2015—AMWA signed onto the AllTrials campaign to end the serious problem that only around half of all clinical trials ever conducted have reported results and thousands more have never even been registered. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being needlessly repeated. The AllTrials campaign is calling for every clinical trial, past and present, to be registered and their results reported. Through the support of individual doctors and patients, professional societies and patient groups, we have already accomplished what many thought impossible. We changed the law in Europe so that clinical trials for drugs are now publicly registered and their results reported. We have even seen a pharmaceutical company—GSK—sign our petition and join us at this year’s annual meeting of the American Association for the Advancement of Science to explain why the time has come to share trial data present and past—and, more importantly, how it can be done.
The AMWA statement: AMWA joins the 85,000 people and 570 organizations that have publicly supported All Trials, a campaign practice that is transforming medical research and pharmaceutical practice. We agree that there is no need to waste research dollars and the effort of scientists by repeating work unnecessarily. We want every trial to have its work published and available regardless of whether the results are favorable or not.

July 01 2015— AMWA has signed on to a letter to President Obama regarding the United States restrictions on foreign aid that banthe ability to provide the full range of sexual & reproductive services, without discrimination. For more information go to: UPR of the US

July 01 2015— AMWA signs on to a coalition letter supporting the Pregnancy Workers Fairness Act promoted by the National Partnership for Women and Families thru because women should not lose their job or financial security because of a pregnancy. You can take action as well. Follow this link to read the letter and add your name: For more information on the bill, check out our website: http://www.nationalpartnership.org/issues/fairness/pregnant-workers-fairness-act.html.
July 12 2015— The American Medical Women’s Association agrees that all clinical trials results should be reported and signs on to this letter with support. AllTrials has united patients and doctors, professional societies and patient groups to tackle the pressing problem of missing clinical trial data. You can endorse AllTrials campaign with an email to alltrials@senseaboutscienceusa.org (ccingtrevor@senseaboutscienceusa.org and jcockerill@senseaboutscience.org).
July 29, 2015– AMWA will be signing on to the attached (draft) letter supporting Planned Parenthood health centers from being opposed from receiving federal public health funding. It was sent to the Hill 08/03/2015. Every day, we see the harmful impact that unequal access to health care has on women and communities across the country, and we therefore strongly support policies that improve access to affordable, quality health care. Policies that would deny Planned Parenthood public health funds only serve to cut millions off from critical preventive care, and we strongly oppose any effort to do so. Should you have any questions, please contact ACOG Government Affairs staff, Rachel Gandell at 202-863-2534 or rgandell@acog.org.

August 25, 2015 — AMWA support letters from SB 128. End-of-Life Option Act (SB 128). This legislation would allow a mentally competent, terminally ill person in the final stages of their disease to request medication from a physician to bring about a peaceful death. The availability of this option can also provide peace of mind to those who are dying and for their families. The extensive, and important, safeguards in SB 128 will ensure that the choice made by a terminally ill person to access aid in dying is informed, deliberate and voluntary.
https://www.compassionandchoices.org/what-you-can-do/get-involved/support-of-the-end-of-life-option-act-sb-128/

September 03, 2015 – AMWA supports sign-on letter that will be sent to Hill prior to the hearing. The Senate Judiciary Committee is planning to hold a hearing on the 20-week abortion ban legislation introduced by Sen. Lindsey Graham in mid-to-late September. http://prh.org