Scientific members of FDA public advisory committees must be technically qualified experts in their field (e.g., clinical medicine, engineering, biological and physical sciences, biostatistics, and food sciences) and have experience interpreting complex data. Candidates must be able to analyze detailed scientific data and understand its public health significance.
An academician/practitioner uses his or her expert knowledge to provide advice on issues under deliberation at the FDA, and may serve as a Scientific/Technical Member, Ex-Officio Member, Patient Family Representative, Pediatric Health Organization Representative, Health Professional Representative, Government Representative, or a General Public Representative on an FDA Advisory Committee.
Other membership types represent specialized knowledge or points of view:
The Food and Drug Administration seeks input from consumers on medical and scientific issues. A key method of ensuring that FDA obtains the points of view of consumers is by including Consumer Representatives on Agency advisory committees.
A Consumer Representative must be able to analyze scientific data, understand research design, discuss benefits and risks, and evaluate the safety and efficacy of products under review. It is also essential that the representative have an affiliation with and/or active participation in consumer or community-based organizations. The role of the Consumer Representative is to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers.
FDA's Advisory Committees include Industry Representatives who act on behalf of regulated industry at committee meetings. The representative discusses an issue before the committee from the perspective of the affected industry and not as an individual from a specific sponsor or firm. Industry Representatives are non-voting members. Industry Representatives on the Tobacco Products Scientific Advisory Committee serve in three different roles that include a Tobacco Manufacturing Representative, Tobacco Manufacturing Small Business Representative, and Tobacco Grower Interest Representative.
To learn more about Patient Representatives, visit the website on the Patient Representative Program in the Office of Health and Constituent Affairs.