The FDA Patient Representative Program® is the agency’s flagship program that offers patients and caregivers the opportunity to provide critical advice to the agency as it regulates medical products—drugs, biologics, and devices.
Role of the FDA Patient Representative®
The role of the FDA Patient Representative® is unique. Patients and advocates are appointed as Special Government Employees (temporary employees) to provide direct input to agency staff as they share valuable insight on their experiences with various diseases, conditions, and devices while gaining access to confidential information. In some cases, Regular Government Employees are able to serve in this role. FDA Patient Representatives engage with scientific members and other experts as they participate on FDA Advisory Committees and panels and consult with agency’s review divisions.
An SGE is a special government employee. FDA appoints all advisory committee members (except the industry representative) as SGEs.
Candidates are carefully recruited and trained to prepare them for various agency-sponsored meetings and activities. It’s through this engagement that we learn of patient needs, priorities and preferences and gather meaningful data that informs medical product development and decision making.
The Program is managed by the Advisory Committee Oversight and Management Staff (ACOMS) within the Office of the Commissioner.
We recruit FDA Patient Representatives on an as-needed basis. Below are some areas of recruitment:
|autism||metastatic breast cancer|
|beta-thalassemia major||metastatic non-small cell lung cancer|
|child cerebral adrenoleukodystrophy||metastatic small cell lung cancer|
|chronic lymphocytic leukemia or indolent forms of non-Hodgkin lymphoma||multidrug-resistant gram-negative infections including hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)|
|diffuse large B-cell lymphoma||neuroblastoma|
|epithelioid sarcoma||ovarian cancer|
|hemophilia||triple-negative breast cancer|
|HIV||type I diabetes|
Criteria for being considered as an FDA Patient Representative®
FDA selects FDA Patient Representatives® on various criteria. To be considered for the program, an applicant must be a legal U.S. citizen at least 18 years of age and have:
- Personal experience with the disease either as a patient, or primary caregiver.
- Ability to be objective while representing the concerns of others in their communities.
- Willingness and ability to communicate in public their views and perspectives.
- Knowledge about most treatment options and research for their areas of experience they are representing.
- Impartiality with minimal to no financial conflicts of interest or ethical issues for self or close family members (for example, financial interest, such as stock, in companies that may be affected by FDA decisions).
Primary Activities for FDA Patient Representatives
- Serve on FDA Advisory Committees and panels that are held to obtain independent expert advice on scientific, technical, and policy matters.
- Give us input earlier in the regulatory medical product development and review process by engaging directly with Division review staff.
Conflicts of Interest
In order to serve as an FDA Patient Representative, candidates will be appointed as Special Government Employees (referred to as “SGEs”). Once appointed, FDA Patient Representatives must adhere to all federal government conflict-of-interest requirements and ethics guidelines. Prior to performing work for the Agency, all SGEs undergo conflict-of-interest screening. Agency staff will assist the SGE with the screening process.
For more information on this topic, view the presentation slides: Financial Conflicts of Interest Overview
Learn what experienced FDA Patient Representatives have to say about their role, the impact that it’s had on their lives, the lessons learned as they’ve served, and more. Watch our video series, “When a Patient Speaks: Testimonials from FDA Patient Representatives."
FDA PATIENT REPRESENTATIVE PROGRAM and FDA PATIENT REPRESENTATIVE are service marks of the US Department of Health and Human Services.