As the FDA continues to advance its patient engagement efforts through its long-term commitment to improving and increasing patient involvement in FDA matters, I am pleased to announce a new initiative, the Patient Engagement Collaborative (PEC). Today FDA published a Federal Register Notice to request nominations from representatives of patient communities to participate in an ongoing forum to discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions.
The PEC will be coordinated by the FDA’s new Patient Affairs Staff (PAS) in the Office of Medical Products and Tobacco (OMPT) and the public-private partnership, the Clinical Trials Transformation Initiative.
The PEC will consist of a diverse group of representatives from the patient community including:
- Patients who have personal disease experience
- Caregivers who support patients, such as a parent, child, partner, other family member, or friend, and who have personal disease experience through this caregiver role
- Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience