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 just 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
Academicians/Practitioners that serve on an FDA Committee can be interesting external experts whose input and insights are highly valuable to pharmaceutical companies. For more information about how to identify external experts who serve on FDA Committees please read our blog