Participate In FDA Advisory Committee Meetings

Members of an FDA Ad Comm

An FDA Ad Comm ordinarily consists of 10 to 15 fixed or “standing” members including the chairperson. Members are selected because they possess expertise specific to the committee’s function. Most committees will also have a consumer representative and an industry representative. FDA Patient Representatives and expert consultants are often added as temporary voting members.

Scientific members:
- Physician-scientists whose specialties or research involves the kinds of therapies being reviewed, including:
  - Statisticians
  - Epidemiologists
  - Medical faculty
  - Chemists
  - Biologists
  - Engineers
  - Nutritionists
  - Toxicologists
  - Experts in preclinical (animal) studies
- As core members of FDA Ad Comms, responsibilities will not be limited to a single disease or a specific therapy of interest. However members of your Scientific/Medical Advisory Board may be interested in learning more about the opportunity:
  - Applying for Membership on FDA Advisory Committees
Industry representatives:
- Address global concerns for industry, not their specific employer.
- Are not the industry Sponsor for the therapy being reviewed.
- May or may not have the ability to vote, depending on the specific committee.
Consumer representatives:
- Offer broad knowledge of consumer rights and needs.
- Have an affiliation with and/or active participation in consumer or community-based organizations.
- Consumer representatives are core members and therefore are not focused on a single disease or specifictherapy. However, the FDA does provide more information about applying to be a consumer representative if you or someone you know is interested:
  - Consumer Representatives on FDA Advisory Committees
FDA Patient Representatives:
- FDA Patient Representatives are recruited and then specially trained to participate as temporary voting members for FDA Ad Comm meetings and to provide input earlier in the regulatory therapy development and review process by engaging directly with Division review staff.
- They are appointed as Special Government Employees (temporary employees) 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.
- Qualifications include:
  - 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 the areas of experience they are representing.
  - Impartiality with minimal to no financial conflicts of interest or ethical issues for self or close family members, for example, a financial interest, such as stock, in companies that may be affected by FDA decisions.
- FDA Patient Representatives are added to the FDA Ad Comm panel for a meeting when a therapy concerns their disease or a disease within their area of expertise.
- Due to the required training, you or a member of your patient community cannot apply to be a Patient Representative for an already scheduled or soon to be scheduled FDA Ad Comm meeting for a therapy for your disorder.
- The FDA provides more information about FDA Patient Representatives including how to apply.
  - About the FDA Patient Representative Program
  - How to Apply to the FDA Patient Representative Program
Consultants: Scientists or medical personnel whose expertise is not represented by the fixed voting membership may be added to an FDA Ad Comm.
- World experts on the topic being discussed are often added as temporary voting members.
- These experts are present only for special meetings.
- Members of your Scientific/Medical Advisory Board may meet the qualifications to be a consultant if there is no conflict of interest.

Resources

FDA Ad Comm Meeting

FDA For Patients Website U. S. Food and Drug Administration (FDA) (link)

Members of an FDA Ad Comm

Applying for Membership on FDA Advisory Committees U. S. Food and Drug Administration (FDA) (link)

Consumer Representatives on FDA Advisory Committees U. S. Food and Drug Administration (FDA) (link)

About the FDA Patient Representative Program U. S. Food and Drug Administration (FDA) (link)

How to Apply to the FDA Patient Representative Program U. S. Food and Drug Administration (FDA) (link)

Providing Testimony

Guidance: The Open Public Hearing at FDA Advisory Committee Meetings U. S. Food and Drug Administration (FDA) (link)

Guidelines for Speakers at the Open Public Hearing of an FDA Advisory Committee Meeting U. S. Food and Drug Administration (FDA) (link)

Tips for Success

What is an Ad Comm? Videorecording Patient Project Muscular Dystrophy (link)

FDA Advisory Committee Meetings: An Overview of the Process & Ways to be Involved Patient Project Muscular Dystrophy (link)

Details & Guidance on Submitting Written Testimony to the FDA Advisory Committee – PPMD Patient Project Muscular Dystrophy (link)

Learn About FDA Advisory Committees U. S. Food and Drug Administration (FDA) (link)

Advisory Committees: Critical to the FDA's Product Review Process U. S. Food and Drug Administration (FDA) (link)

The Open Public Hearing at FDA Advisory Committee Meetings U. S. Food and Drug Administration (FDA) (link)

Public Conduct During FDA Advisory Committee Meetings U. S. Food and Drug Administration (FDA) (link)