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  4. About the FDA Patient Representative Program
  1. Learn About FDA Patient Engagement

About the FDA Patient Representative Program

The FDA Patient Representative Program offers patients and caregivers the opportunity to provide critical advice to the agency as it regulates medical products—drugs, biologics, and devices.

Role of the FDA Patient Representative

The role of the FDA Patient Representative is unique. Patients and advocates are typically appointed as Special Government Employees (SGEs) to provide direct input to agency staff as they share valuable insight on their experiences with various diseases, conditions, and devices while gaining access to confidential information. FDA Patient Representatives engage with scientific members and other experts as they participate on FDA advisory committees and panels and consult with agency’s review divisions. 

Candidates are carefully recruited and trained to prepare them to serve as Patient Representatives. It’s through this engagement that we learn of patient needs, priorities, and preferences and gather meaningful data that informs medical product development and decision making.

The Program is managed by the Advisory Committee Oversight and Management Staff (ACOMS) within the Office of the Commissioner.

Recruitment

We recruit FDA Patient Representatives on an as-needed basis. Below are some areas of recruitment:

Recruitment Areas
autism metastatic breast cancer
beta-thalassemia major  metastatic non-small cell lung cancer
child cerebral adrenoleukodystrophy metastatic small cell lung cancer
chronic lymphocytic leukemia or indolent forms of non-Hodgkin lymphoma multidrug-resistant gram-negative infections including hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)
diffuse large B-cell lymphoma neuroblastoma
epithelioid sarcoma ovarian cancer
hemophilia  triple-negative breast cancer
HIV type I diabetes

 

Criteria for being selected as an FDA Patient Representative

FDA selects FDA Patient Representatives based on various criteria. To be considered as a Patient Representative, an applicant must be a legal U.S. citizen at least 18 years of age and have:

  • Personal experience with the disease either as a patient or primary caregiver.
  • Ability to be objective while representing the concerns of others in their communities.
  • Willingness and ability to communicate in public their views  and perspectives.
  • Knowledge about most treatment options and research for their areas of experience they are representing.
  • Impartiality and compliance with Federal ethics requirements (for example, financial interest, such as stock, in companies that may be affected by FDA decisions).

Primary Activities for FDA Patient Representatives

  • Serve on FDA advisory committees and panels that are held to obtain independent expert advice on scientific, technical, and policy matters.

Conflicts of Interest

In order to serve as an FDA Patient Representative, candidates will be appointed as an SGE. Once appointed, FDA Patient Representatives must adhere to all Federal Government conflict-of-interest requirements and ethics guidelines. Prior to performing work for the Agency, all SGEs undergo conflict-of-interest screening. Agency staff will assist the SGE with the screening process.

For more information on this topic, view the presentation slides: Financial Conflicts of Interest Overview

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."

For more information about serving as a Patient Representative, check out our Frequently Asked Questions, or email us at FDAPatientRepProgram@fda.hhs.gov.

FDA PATIENT REPRESENTATIVE PROGRAM and FDA PATIENT REPRESENTATIVE are service marks of the US Department of Health and Human Services.

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