The FDA Patient Representative Program is managed by the Office of Health and Constituent Affairs within the Office of the Commissioner. The Office of Health and Constituent Affairs-Patient Liaison Program coordinates the recruitment, training, and retention for over 200 FDA Patient Representatives, who are patients or primary caregivers to patients.
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These FDA Patient Representatives are knowledgeable and experienced in over 300 diseases and conditions and participate on 47 FDA Advisory Committees and panels, and in review division meetings. These Patient Representatives provide direct input to inform the Agency’s decision-making associated with medical products for drugs, biologics, and medical devices.
Unlike other Advisory Committee members, FDA’s selection of patients serving involves identifying those with direct experience with the disease. Usually this means that a FDA Patient Representative is specific to the Advisory Committee meeting topic. Also, FDA Patient Representatives serve in review division meetings and FDA workshops. Requests for FDA Patient Representative involvement in FDA regulatory meetings continues to increase to actively implement FDASIA section 1137.
We are committed to making more opportunities for patients to participate in FDA decision-making. Our FDA Patient Representative Program brings the patient voice to the discussions about new and already approved drugs and devices and policy questions.
We recruit FDA Patient Representatives on an as-needed basis to:
Help advise us on drugs, devices, and biologics that are currently being considered for approval
Give us input earlier in the regulatory medical product development and review process.
On this page you will find information about:
Patient Representatives provide FDA with the unique perspective of patients and family members affected by a serious or life-threatening disease. As an FDA Patient Representative, you MAY serve in one or more ways. Even if you are selected as a Patient Representative it is possible you will not serve at all. Some of the ways a Patient Representative may serve are:
On FDA Advisory Committees, where you will offer the patient perspective, ask questions, and give comments to assist the committee in making recommendations
As a consultant for the review divisions (doctors and scientists who review data to determine whether the medical product's benefits outweigh the potential risks)
As presenters at FDA meetings and workshops on disease-specific or regulatory and health policy issues
FDA selects Patient Representatives based on a number of different factors. 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 such as a family member or friend
Ability to be objective while representing the concerns of other patients
Willingness to communicate their views
Knowledge about treatment options for the disease and research in that area
No financial or ethical conflicts of interest for self or close family member (for example, financial interest, such as stock, in companies that may be affected by FDA decisions).
A conflict of interest, for the purposes of FDA Advisory Committees, occurs when an individual selected to serve on an advisory committee has financial interests that may be impacted by the individual’s work on the advisory committee.
Financial interests include anything currently held that can financially impact the SGE or the interests of others with whom the SGE has a certain relationship, including the SGE’s spouse, minor children, business partners, employer, and organizations in which the individual serves as officer, director, or trustee. Examples include:
Interests through ownership, partnership, LLC
Grants or contracts
For more information view the presentation slides: Financial Conflicts of Interest Overview
For more information about the FDA Patient Representative Program, check out our Frequently Asked Questions. If you don’t find the answer, contact us at 301-796-8460.