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FAQs About the FDA Patient Representative Program

Who can be a FDA Patient Representative®?

FDA Patient Representatives have a personal history with a disease, condition, or experience with a medical device. They are the voice of the patient community. To be considered as a candidate, you must be either a patient or a caregiver  Learn more about the FDA Patient Representative Program®.

Do FDA Patient Representatives® need to have a scientific or medical background?

No, a scientific or medical background is not necessary to serve as a Patient Representative. However, general knowledge of a disease, condition, or medical device and the ability to consider complex information is helpful for understanding and discussing the scientific data. Most importantly, it’s the patient perspective that brings the unique and important contributions to the work performed at FDA.

What do FDA Advisory Committees and Panels do?

FDA Advisory Committees and Medical Device Panels provide expert advice to help FDA make decisions about new drugs, vaccines, medical devices, and discuss public health issues. Committee members typically vote on questions that the agency poses. The meetings are usually held in the Washington, DC, area in a public session with an audience, including members of the media. Learn more about FDA Advisory Committees.

Do FDA Patient Representatives® vote when serving on an Advisory Committee?

FDA Patient Representatives who serve on Advisory Committees that review drug and biologic therapies are temporary members of the Committee with voting privileges. However, FDA Patient Representatives who serve on Medical Device Panels that review medical device therapies are temporary members without voting privileges.

How does an FDA Patient Representative® take part in an FDA Advisory Committee meeting?

FDA Patient Representatives are notified in advance of an upcoming Advisory Committee meeting in order to plan ahead. The meetings are held over 1 to 2 days within the Washington, DC, area. The FDA Patient Representative participates in person. FDA pays a salary for the time spent during meeting and also covers expenses, such as flights, lodging and meals, if the meeting is more than 50 miles from the FDA Patient Representative’s home.

Who are the members of an FDA Advisory Committee?

Advisory Committees have experts in the appropriate scientific fields relevant to the meeting topic (e.g., medicine, engineering, statistics, or other sciences), as well as consumer, industry, and an FDA Patient Representative®.

How does an FDA Patient Representative® prepare for an Advisory Committee?

It is important for the FDA Patient Representative® to have background information on the medical product being reviewed. About 2 to 3 weeks before the meeting, the FDA Patient Representative will receive a meeting package that contains all information necessary for the meeting. FDA staff are available to answer any questions.

How often do FDA Patient Representatives® serve?

FDA Patient Representatives® serve at any point when the agency needs their input at meetings or in consultation with review Divisions. Therefore, the frequency of service varies depending on those needs–while some serve once a year, others may serve several times a year, and some may not serve at all during their 4-year term.
 

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."

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