For Patients

About the FDA Patient Representative Program ℠

The FDA Patient Representative Program ℠ is managed by the Advisory Committee Oversight and Management Staff (ACOMS) within the Office of the Commissioner. ACOMS coordinates the recruitment, training, and management of FDA Patient Representative Program ℠ consultants, who are patients or primary caregivers.

We are currently looking for Patients or caregivers with advocacy experience who have been diagnosed or experience with:

merkel cell carcinoma

childhood cerebral adrenoleukodystrophy

opioid use (pediatric)

obesity

phenylketonuria

opioid addiction

retinitis pigmentosa

male hypogonadism

type II diabetes

naloxone use

glaucoma

pediatric inflammatory bowel disease

retinal implants

neuroendocrine tumors

opioid withdrawal

keratoconus

HIV

lupus

sarcoma

familial chylomicronemia syndrome

  Information on how to apply to the FDA Patient Representative Program

  

FDA Patient Representative Program ℠

These FDA Patient Representative ℠ consultants provide knowledge and experience in over 300 diseases and conditions and participate on FDA Advisory Committees and panels, and in review division assignments. These FDA Patient Representatives provide direct input to the Agency’s decision-making process associated with medical products for drugs, biologics, and medical devices.

Unlike other Advisory Committee members, FDA’s selection of patients serving involves identifying those with direct experience with the disease. Usually this means that an FDA Patient Representative ℠ is specific to the Advisory Committee meeting topic.  Also, FDA Patient Representatives serve in review division meetings and FDA workshops.

We are committed to making more opportunities for patients to participate in FDA decision-making. Our FDA Patient Representative Program brings the patient voice to the discussions about new and already approved drugs and devices and policy questions.

We recruit FDA Patient Representatives on an as-needed basis to: 

  • Help advise us on drugs, devices, and biologics that are currently being considered for approval.

  • Give us input earlier in the regulatory medical product development and review process.

On this page you will find information about:

Role of the FDA Patient Representative

FDA Patient Representatives provide FDA with the unique perspective of patients and family members who are affected by a serious or life-threatening disease. As an FDA Patient Representative, you MAY serve in one or more ways. Even if you are selected as a FDA Patient Representative it is possible you will not serve at all. Some of the ways a FDA Patient Representative consultant may serve are:

  • On FDA Advisory Committees, where you will offer the patient or caregiver perspective, ask questions, and give comments to assist the committee in making recommendations.

  • As a consultant for the review divisions (doctors and scientists who review data to determine whether the medical product's benefits outweigh the potential risks).

  • As presenters at FDA meetings and workshops on disease-specific or regulatory and health policy issues.

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Criteria for Becoming a FDA Patient Representative

FDA selects FDA Patient Representatives based on a number of different factors. To be considered for the program, an applicant must be a legal U.S. citizen at least 18 years of age and have: 

2018 Patient Representative Information
  • Personal experience with the disease either as a patient, or primary caregiver.

  • Ability to be objective while representing the concerns of other patients.

  • Willingness to communicate their views and the communities views.

  • Knowledge about most treatment options for the disease and research in that area of the disease they are representing.

  • No financial or ethical conflicts of interest for self or close family member (for example, financial interest, such as stock, in companies that may be affected by FDA decisions).

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Conflict of Interest

A conflict of interest, for the purposes of FDA Advisory Committees, occurs when an individual selected to serve on an advisory committee has financial interests that may be impacted by the individual’s work on the advisory committee.
Financial interests include anything currently held that can financially impact the Special Government Employee (SGE) or the interests of others with whom the SGE has a certain relationship, including the SGE’s spouse, minor children, business partners, employer, and organizations in which the individual serves as officer, director, or trustee. Examples include:

  • Stocks

  • Bonds

  • Interests through ownership, partnership, LLC

  • Consulting arrangements

  • Grants or contracts

  • Employment

For more information view the presentation slides: Financial Conflicts of Interest Overview

For more information about the FDA Patient Representative Program, check out our Frequently Asked Questions. If you don’t find the answer, contact us at 301-796-8460.

 

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Email FDA Patient Representative Program

 

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

Page Last Updated: 05/03/2018
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