For Patients

About the FDA Patient Representative Program

FDA Patient Representative Program Needs

The FDA Patient Representative Program is managed by the Office of Health and Constituent Affairs within the Office of the Commissioner.  The Office of Health and Constituent Affairs-Patient Liaison Program coordinates the recruitment, training, and retention for over 200 FDA Patient Representatives, who are patients or primary caregivers to patients.  These FDA Patient Representatives are knowledgeable and experienced in over 300 diseases and conditions and participate on 47 FDA Advisory Committees and panels, and in review division meetings. These Patient Representatives provide direct input to inform the Agency’s decision-making 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 a FDA Patient Representative is specific to the Advisory Committee meeting topic.  Also, FDA Patient Representatives serve in review division meetings and FDA workshops. Requests for FDA Patient Representative involvement in FDA regulatory meetings continues to increase to actively implement FDASIA section 1137.

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

Patient Representatives provide FDA with the unique perspective of patients and family members 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 Patient Representative it is possible you will not serve at all. Some of the ways a Patient Representative may serve are:

  • On FDA Advisory Committees, where you will offer the patient 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

back to top

Criteria for Becoming a FDA Patient Representative

FDA selects 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: 

  • Personal experience with the disease either as a patient, or primary caregiver such as a family member or friend

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

  • Willingness to communicate their views

  • Knowledge about treatment options for the disease and research in that area

  • 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).

back to top

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 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

How to Apply to the FDA Patient Representative Program

Before you begin, be sure to read the criteria to make sure you qualify and check out our Frequently Asked Questions for more information.

To be considered for our program, please provide the following information about yourself and your experience with a specific disease.

Contact Information

  • Full Name
  • Email Address
  • Phone Number

Personal Disease Experience

Briefly describe your personal experience with a specific serious disease, either as a patient or as a primary caregiver.

  • Why you are interested in becoming a Patient Representative and how you feel your experience makes you a good candidate.

Advocacy experience
Briefly describe any advocacy work you have done in the specific disease area.

  • Tell us how you’ve supported and promoted patient health and welfare around this specific disease.

Work and Volunteer Experience
Briefly describe your work and/or volunteer experience you’ve done related to the specific disease area.

Ability to Represent and Communicate Patient Perspectives
Describe your ability to represent patients and communicate their perspectives. Examples include: connections to groups or organizations; involvement with internet forums; experience giving speeches; author or edit related articles, books, blogs, websites, etc.

back to top

Privacy Act Notice: FDA will use the information applicants submit to evaluate their suitability for positions as Patient Representatives. Click here to view the full notice that required by the Privacy Act(5 U.S.C. §552a(e)(3)

Submit Your Application for Consideration

Send an email to FDAPatientRepProgram@fda.hhs.gov and include the information requested under the heading “How to Apply to the FDA Patient Representative Program”.
If your experience matches our areas of need we will contact you for more information.

If we do not contact you at this time, we will keep your information on file for future reference if there is a need in your disease area or condition.

Training

Selected applicants receive training to ensure that they are comfortable in their new role. FDA staff offers training and support to Patient Representatives about policies, procedures, and regulations. Training includes:

  • FDA 101 teleconference

  • Webinars

  • Annual FDA Patient Representative workshops for first-year representatives

  • Other one-on-one support as needed

back to top

Frequently Asked Questions

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.

back to top

 

Page Last Updated: 03/25/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.