For Patients

FAQs About the FDA Patient Representative Program ℠

Who Can Be a FDA Patient Representative℠?

FDA Patient Representatives ℠ consultants usually have a history with disease being discussed; they are the “voice” for patients’ concerns. In some cases, a caregiver or a member of a patient advocacy organization might be selected.

Patient Representatives Making a Difference

FDA Patient Representatives ℠ can take part in one or both of the following ways:

  1. during private discussions between FDA and a company that is creating a new product,

  2. as a participant in an FDA Advisory Committee meeting reviewing a medical product or public health policy.

Learn about the FDA Patient Representative Program.

Do FDA Patient Representatives℠ Need a Scientific Background?

No, a background as a scientist or researcher is not necessary. However, general knowledge of the disease and the ability to consider complex information is helpful for understanding and discussing the scientific data. Most importantly, experience as a patient helps Patient Representatives bring a unique and important perspective to FDA.

What Does an FDA Advisory Committee Do?

Advisory Committees provide expert advice to help FDA make good decisions about new drugs, vaccines, medical devices, and other public health issues. Committee members typically vote on questions FDA poses to the committee. The meetings are usually held in the Washington, DC, area in an open session with an audience, including members of the public and 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 usually voting members. FDA Patient Representatives who serve on Advisory Committees that review medical device therapies are non-voting members. Other than voting on the questions FDA poses to the committee, non-voting members have the same rights as other committee members.

How Does a FDA Patient Representative Take Part in an FDA Advisory Committee meeting?

FDA Patient Representatives are notified about an upcoming Advisory Committee meeting and given plenty of time to make arrangements to attend. The meetings are held on 1 to 2 days in the Washington, DC, area. The FDA Patient Representative participates in person. FDA pays a salary for the time spent in meetings and covers travel expenses, such as 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?

Committees have experts in the appropriate scientific fields (e.g., medicine, engineering, statistics, or other sciences), as well as consumer, industry, and FDA Patient Representatives.

How Does a FDA Patient Representative Prepare for an Advisory Committee or Drug Development Meeting?

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 to get ready for the meeting. After the FDA Patient Representative reads the information, FDA staff can answer any questions by telephone.

Page Last Updated: 03/12/2018
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