The FDA is committed to expanding patient involvement in the regulatory work it does, building on provisions in both the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017.
The Patient Affairs Staff (PAS) in the Office of Medical Products and Tobacco is devoted to supporting cross-cutting patient engagement activities across the FDA. PAS is working in close collaboration with the Medical Product Centers, the Office of External Affairs (OEA), and other FDA offices to complement and support ongoing patient engagement initiatives.
A unified FDA culture and system infrastructure that enhances patient engagement throughout the lifecycle of medical product development and regulatory decision-making to further the availability of safe and effective medical products.
To coordinate and support patient engagement activities across the medical product centers to facilitate awareness and collaboration with patients, their advocates and the FDA under FDASIA section 1137, FDARA and 21st Century Cures.
- Creating and assisting with public and private collaborations and partnerships to discuss regulatory topics of interest.
- Leading cross-center programs and activities that can leverage best practices and enhance patient engagement.
- Enhancing the FDA’s external communication platforms to expand public awareness and help patients, caregivers, and advocates navigate the FDA engagement activities and regulatory processes.
Patient Affairs Staff Updates
- July 11, 2018: FDA's Patient Affairs Staff Taking the Lead
FDA Patient Affairs Initiatives
To learn more about these FDA patient affairs initiatives, visit About FDA Patient Engagement.
- Initiatives for patients to engage with FDA
- Patient Engagement Collaborative
- FDA and European Medicines Agency Patient Engagement Cluster
- FDA Patient Council
- MOU with the National Organization of Rare Disorders
- Patient-Focused Drug Development Glossary
Patient Affairs Staff Leadership
Andrea-Furia Helms, Director
Samir Shaikh, Deputy Director
For more information about the Patient Affairs Staff (PAS) please email PatientAffairs@fda.hhs.gov or call 301-796-8460.