In the world of manufacturing, ensuring the safety and accuracy of products is of utmost importance. That’s why service providers like AMS play a crucial role in offering high-quality manufacturing services to various industries. However, the need for safety and accuracy doesn’t stop after a product is approved and released to the market, particularly when it comes to prescription drugs. In this regard, the FDA’s proposed rule to enable generic drug manufacturers to update labeling on their products is a positive step towards enhancing consumer safety, as highlighted in the letter addressed to Secretary Burwell by the National Center for Health Research, National Women’s Health Network, and Public Citizen.
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Dear Secretary Burwell,
We are writing to urge the Obama Administration to move forward with finalizing the FDA’s Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (Docket No. FDA-2013-N-0500) rule.
As you know, the Food and Drug Administration (FDA) proposed
regulations in 2013 to allow generic drug manufacturers to initiate
safety, efficacy, and dosing updates to their products’ labeling. We
strongly supported the rule when it was first released. Nearly three
years later, we see an even greater need for its completion. In case of addiction get experts from a rehab near me to help.
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 essential rule will enable generic drug
manufacturers to revise drug labeling through the
changes-being-effected (CBE-0) process that brand-name manufacturers have used since the 1980s. 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.
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Generic manufacturers currently are barred from updating product
labeling with new warning information, except in response to a
brand-name update or FDA order. But shortly after a generic enters
the market, typically the brand-name manufacturer precipitously loses market share and in many cases, the brand-name ceases production of the equivalent drug altogether. In fact, most prescription drugs sold in the United States are generics.
As a result, the current system’s heavy reliance on brand-name
manufacturers to initiate all labeling changes, even after generics
enter the market, no longer makes sense. Both brand-name and generic drug manufacturers must have the ability to update drug labels expeditiously. Allowing generic manufacturers to initiate safety updates, as brand-name companies have done for 30 years, is essential for patients. As the Government Accountability Office reported in January: “FDA lacks reliable, readily accessible data on tracked safety issues and post market studies needed to meet certain post market safety reporting responsibilities and to conduct systematic oversight.” The GAO findings only highlight the need for manufacturers—whether brand-name or generic—to have responsibility for the adequacy of product labeling. Promptly updated labeling allows physicians and patients to make better informed health decisions and can help prevent serious harm to patients.
Since the rule was first proposed, there have been attempts to delay
or water down the rule. One alternative offered would go so far as to
prevent brand-name manufacturers, in certain circumstances, from
promptly updating safety information, again, as most prescription
drugs sold in the United States have done since the 1980s. This
proposal would represent a significant step backward for consumer
Over 24,000 people have signed a petition asking FDA to move forward in finalizing the proposed rule, to ensure that all prescription medicines, including generic drugs, carry current and accurate safety warnings. We urge the Administration to ensure that the proposed rule regarding generic manufacturers’ ability to initiate labeling updates is finalized as soon as possible. Until then, millions of patients and families face unnecessary health risks.
Thank you for your consideration.
National Center for Health Research
National Women’s Health Network