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Updated October 2005
The Patient Representative is responsible for providing the Food and Drug Administration (FDA) and the advisory committee the unique perspective of patients and family members directly affected by a serious or life-threatening disease. Among other things, the Patient Representative should have:
The Patient Representative must be well-informed about patient concerns and have the ability to understand and actively participate in advisory committee discussions. The Patient Representative serves on advisory committees when a product or therapy (drug, biologic or medical device) related to a serious or life-threatening disease is under review.
Primarily, Patient Representatives serve on advisory committees that review products and therapies for the diagnosis and treatment of HIV/AIDS and cancer. However, the agency also includes Patient Representatives on committees that review products and therapies related to other serious and life-threatening diseases on a case-by-case basis. Additional diseases which have had Patient Representatives include:
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The Office of Special Health Issues (OSHI), in cooperation with Center staff, provides orientation for Patient Representatives to assist them in carrying out their responsibilities. The orientation includes basic information about:
The Patient Representative will receive orientation and training on an individual basis, after s/he has been selected to participate in a specific advisory committee meeting. Prior to serving on a committee, the Patient Representative may have an opportunity to observe an advisory committee meeting in order to gain additional insights on the deliberation process. The OSHI staff encourages the Patient Representative to communicate with other individuals who have served in this capacity to learn about their experience. The staff will also be available to respond to questions related to the advisory committee process and to provide ongoing support.
The Patient Representative's role is to provide the advisory committee and FDA insight on issues, problems, and/or questions pertinent to the viewpoint of patients and family members living with a specific serious or life-threatening disease. S/he serves as either a voting or non-voting member of the advisory committee.
At the conclusion of each meeting, the Patient Representative will be encouraged to provide OSHI with a brief summary of his/her experience on the advisory committee and suggestions for enhancing patient representation, if any.
For more information on the responsibilities of Patient Representatives, see the brochure "Patient Representatives to FDA Advisory Committees."
Patient Representatives who serve on advisory committees which review therapies, products, or issues other than those related to medical devices are usually voting members. Voting Patient Representatives must be appointed as special government employees (SGEs). This appointment requires Patient Representatives to disclose personal financial information to the FDA in order to determine whether their financial interests pose a possible conflict of interest on an advisory committee. They have the same responsibilities as other voting members. They are expected to provide the patient perspective, ask questions, and offer comments to assist the committee in making recommendations.
Patient Representatives who serve on advisory committees which review therapies, products, or issues related to medical devices (other than oncology) are, usually, non-voting members. Non-voting members have the same rights as other committee members except that they may only vote on procedural matters concerning the conduct of the meeting. They are expected to provide the patient perspective, ask questions, and offer comments to assist the committee in making recommendations.
All Patient Representatives are reimbursed for travel, lodgings, and per diem expenses relative to their participation on an advisory committee. At the time of appointment, the Executive Secretary (or other staff) of the advisory committee on which the Patient Representative serves will provide guidance on the requirements for submission of documentation and receipts for reimbursement.
Anyone may nominate a candidate to serve as a Patient Representative on FDA Advisory Committees. The nominee must be aware and supportive of his/her nomination. Self-nominations are also accepted. Nominations must include the following information:
Mail, fax, or e-mail the nomination to:
FDA Patient Representative Program
Office of Special Health Issues (HF-12)
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
Fax: (301) 443-4555
Phone: (301) 827-4460
E-mail: oshi@oc.fda.gov