FDA Advisory Committees

The FDA uses committees to obtain independent expert advice on scientific, technical, and policy matters.

Individuals must fulfill certain criteria to be eligible to become FDA advisory committee members, specifically, they must be technically qualified experts in their field, e.g. clinical medicine, engineering, biological and physical sciences, or biostatistics and have experience interpreting complex data. Candidates must be able to analyze detailed scientific data and understand its public health significance.
Typically advisory committee members fall into one of four categories :

  • Academician/Practitioner - are domain experts that provide advice on issues under deliberation by the FDA.
  • Consumer Representative - provide input from the points of view of consumers and represent the consumer perspective. Consumer representatives need to be able to analyze scientific data, understand research design, discuss benefits and risks, and evaluate the safety and efficacy of the products that are being reviewed. In addition, the individual must be part of a consumer- or community-based organization. (find reference)
  • Industry Representative - represent the perspective of the industry as a whole rather than that of one specific company. Due to potential conflicts of interest industry representatives are generally non-voting members of the committee.
  • Patient Representative - have a unique role, they are appointed as special Government Employees (temporary employees) to provide the FDA staff with their insights and experiences with various diseases. Patient representatives help the FDA understand patient needs, priorities and preferences that inform product development and decision making.

Relevance for medical affairs

Experts serving on a FDA advisory board or committee are highly influential and have significant impact on the FDA’s decisions. Therefore knowing who they are, developing a detailed profile including information about their publications, clinical trials, speaking engagements or other relevant activities and understanding their scientific behavior and opinions is highly important for medical affairs professionals.

Who Is Advising Regulatory Authorities and Why You Should Know

External Experts
Health Economics and Outcomes Research (HEOR)