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FDA
updated January 2006
"Respect for patients' autonomy is now considered
fundamental to the practice of medicine."
Norman J. Levinsky, M.D.
New England Journal of Medicine, February 22, 1996
Patient participation is important to medical decision making, whether the setting is a doctor's office or a government agency. The Food and Drug Administration (FDA) is committed to expanding opportunities for patients to participate in FDA's decision making. The FDA invites Patient Representatives to participate in its Advisory Committee meetings to discuss medical products for the treatment of serious or life-threatening diseases such as cancer or AIDS. The medical product discussed may be a drug, a biologic product such as a vaccine, or a medical device.
Patients commonly discuss treatment options with their physician, but the concept of patient participation in the medical product approval process is relatively new. We believe the right of patients to participate in this process is undeniable.
Q: What functions do FDA Advisory Committees serve?
A: They provide independent expert advice, helping the FDA make sound decisions about new drugs, biologics, medical devices, and other public health issues.
Q: Who serves on FDA Advisory Committees?
A: Committee members are scientific experts such as physician-researchers and statisticians, as well as representatives of the public, including patients.
Q. Does the FDA conduct the meetings?
A: No. Each FDA Advisory Committee meeting is conducted by the Committee Chairperson, who is typically a physician-researcher affiliated with a university medical center.
Q: Who serves as a Patient Representative?
A: Patient Representatives usually have a history of the disease for which a new treatment will be discussed, with the ability to effectively communicate patient concerns. In some cases, a care giver or a representative of a patient group might be chosen to serve.
Q: Is it necessary for a Patient Representative to have a scientific
background?
A: A background as a scientist or researcher is not necessary, but a general knowledge of the disease, scientific principles and basic statistics is important for comprehension of the scientific data presented. More importantly, their experience as a patient enables Patient Representatives to bring a unique perspective to FDA Advisory Committees.
Q: How Much time does it take to read and review the material provided
to a Patient Representative before an FDA Advisory Committee meeting and to
prepare for the meeting?
A: The Patient Representatives should plan on spending at lease ten hours reviewing the material for an Advisory Committee meeting, keeping in mind that they may receive this material only a few days prior to the meeting. This material is prepared by FDA staff from a number of sources, including the FDA medical review staff, the drug company staff, or expert consultants to the FDA. The material presents detailed technical descriptions of methodology and findings from clinical trials conducted on the new therapy to be considered, as well as other relevant information.
Q: Is the Advisory Committee meeting material confidential?
A: Yes. Although the meetings are usually conducted in open public session, often before hundreds of people and with national press coverage, the reports and other documents provided to an FDA Patient Representative are confidential. Training is provided to FDA Advisory Committee members about public disclosure and discussion of these reports and documents, as well as the appropriateness of pre-meeting contacts with other patients, committee members, the press, manufacturers, and FDA staff.
Q: Where do the FDA Advisory Committees meet and what is a Patient
Representative's financial and time commitment for a meeting?
A: FDA Advisory Committees meet in the metropolitan Washington, D.C. area. Committee members usually fly to a Washington-area airport and stay at a designated hotel at government expense. Local transportation and meal expenses are paid by the committee members as they occur, with reimbursement at government rates usually provided within 60 days following the committee meeting. A modest honorarium is provided for each day of service at the Advisory Committee meeting. Meetings generally last one or two days, and might involve the discussion of more than one product. The Patient Representative's participation is limited to the discussion of the product related to the disease each has experienced, and thus service in a meeting generally lasts only one day.
Q: What kinds of questions are posed to Patient Representatives during
FDA Advisory Committee meetings?
A: The entire committee is asked to discuss questions prepared and distributed to the Committee in advance by FDA staff. Examples of questions are, "Based upon review of available data, do you find this new drug safe and effective?" or "Are the risks of this marketed medical device acceptable now that this serious adverse event has been associated with its use?" Patient Representatives may choose to comment, if they believe they have experience relevant to the discussion. Of particular interest to Patient Representatives may be questions which arise during FDA Advisory Committee deliberations, such as, "Does the proposed clinical trial provide adequate disclosure of risk information to patients in a manner that is understandable?" or "Does the fatigue associated with the use of this biologic limit its usefulness in this patient population?" Patient Representatives may also ask FDA reviewers, company officials, or medical researchers participating in the Advisory Committee about issues of concern to them.
Q: Are FDA Patient Representatives subject to the U.S. Government's
conflict-of-interest rules?
A: Yes. As Special Government Employees, they must follow the U.S. Government's rules regarding direct financial interest (including direct stock ownership) in companies that may be affected by the deliberations of the Advisory Committee.
Q: Where can I learn more about the FDA Patient Representative Program?
How do I nominate someone or apply to become a Patient Representative?
A: The FDA video, When a Patient Speaks ... Patient Representatives to the FDA Advisory
Committees, illustrates the role of Patient Representatives and others actually
involved in this process. You may request a copy by calling the Office of Special
Health Issues at (301) 827-4460. For more information or to make a nomination
you can also e-mail us at oshi@oc.fda.gov.
Additional sources of information include:
FDA Advisory Committees solicit nominees to serve as ad hoc patient representatives on various advisory committees that might consider issues and therapies related to HIV/AIDS, cancer, and other diseases.
Revised January 2006, Office of Special Health Issues