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U.S. Department of Health and Human Services

For Consumers

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Patient Representative Program

Background

The patient’s perspective 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 the FDA’s decision making. Because patients wanted and needed a more active role in medical product development and regulation of medical products, the FDA developed the Patient Representative Program. The Program brings the patient voice to the FDA advisory committee meetings to ensure input into important medical product review and policy questions. The first Patient Representative served on the Antiviral Drugs Advisory Committee for HIV on February 13-14, 1991. 

2 FDA Patient Representative 2012

As part of the "FDA Initiative on Reinventing the Regulation of Cancer Drugs," the Cancer Liaison Program was charged with devoloping a process for:    

  • recruitment of patient represenatives
  • assessment of patient representatives
  • selection of patient representatives to serve as members of cancer-related advisory committees in the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH).

This initiative intended to:

  • provide representation for cancer patients
  • ensure that the selection process will provide for broad representation in the nominee pool,
  • develop criteria for the selection of the patient representatives.

On December 13, 1996, the Lead Deputy Commissioner for Operations announced that patient representatives would have full voting privileges of FDA advisory committee members. The criteria for both the nomination and selection process will help ensure that the patient representative will provide the perspective of the patients with the disease for which a therapeutic product is being considered by the advisory committee.

Patient Representative Program

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:

  • Personal experience with and/or be knowledgeable about the specific illness or condition under discussion by the committee;

  • The ability to articulate the perspective of patients;

  • Experience as a patient advocate;

  • Formal affiliation with a patient advocacy organization;

  • The ability to identify issues through communication with patient constituencies.

FDA Patient Representative 2012 

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To Learn More About the Patient Representative Program

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