to carry out its regulatory responsibilities regarding drugs, biologics, and medical devices.
The scope of a single advisory committee may also be quite broad; some topics may constitute a discipline or subspecialty in themselves. Consequently, the agency needs a broad array of expertise, both clinical and nonclinical; it also has an interest in selecting and recruiting advisory committee members who are recognized by their peers for their professional competence. The FDA regulations cited above do not go beyond the general criterion of "expertise in the subject matter" to address specific qualifications or desired characteristics for advisory committee membership. Here, we examine the qualifications.
It is only reasonable that if candidates are being sought for technical advisory committees, scientific or technical competence should be the primary criterion. The IOM committee believes that the advisory committee system will function most effectively and best serve the needs of the public and the agency if the FDA routinely attracts and retains individuals who meet a high standard of excellence as clinicians and scientists.
The IOM committee strongly endorses the criterion or scientific or technical competence as a requirement for selecting all voting members of FDA technical advisory committees.
The IOM committee adopted the view that the competence needed on an advisory committee should include the clinical expertise necessary to evaluate a sponsor's submission.* This expertise involves not only clinicians and scientists from the pertinent disciplines but clinical investigators who are experienced in the design, conduct, and interpretation of drug or medical device clinical trials. However, in its deliberations the IOM committee did not support the view that the FDA should develop guidelines to define either the minimum or the optimum level of qualifications or expertise for potential advisory committee members. The reasons for not pursuing this course are indicated later in the discussion of "balance."
In this context, the IOM committee acknowledges that "diversity goals" of gender, race-ethnicity, and geography guide the selection of advisory committee members. In the committee's view, these diversity goals are not incompatible with the criterion of scientific and technical competence but