Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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5 Committee Membership
5 Committee Membership
Pages 116-126
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From page 116... ...
This chapter deals primarily with voting members of technical advisory committees, although representative members are also discussed. The ability of the Food and Drug Administration to attract and retain qualified individuals as members of its technical advisory committees Is critical to the successful performance of the advisory committee system.
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From page 117... ...
The IOM committee believes that the advisory committee system will function most effectively and best seine 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. Ihe TOM committee strongly endorses the criterion of scientific or technical competence as a requirement for selecting all voting members of FOA technical advisory committees.
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From page 118... ...
Other factors include the difficulties of identifying such individuals and a low rate of acceptance of appointment to FDA advisory committees by identified individuals from these groups. The identification problem stems in part from the fact that the agency's current practices are insufficient to uncover a critical mass of these candidates.
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From page 119... ...
The IOM committee recommends that the Department of Health and Human Services eliminate its policy prohibiting dual committee membership and that qualified candidates for FDA advisory committees be allowed to decide whether they wish to serve on more than one Public Health Service committee. However, it Commends that the Food and Drug Administration exhaust other means of recruitment before it resorts to selecting persons who serve on other advisory committees.
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From page 120... ...
The committee rejected this concept on the grounds that the primary role of advisory committees is to provide the agency with the best scientific interpretations and advice and not to represent specific constituenaes. Furthermore, under Committee Operations" the IOM committee recognized the importance of input to advisory committee deliberations from nonscientific sources such as patients, industry, and consumer groups and concluded that such input can be best achieved by public testimony that relates directly to the specific agenda of an advisory committee meeting.
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From page 121... ...
~. The annual notice lists the specific advisory committees for which it is known that vacancies of voting members will occur in the next 12 months; also published is a list of committees for which vacancies are not expected but may occur.
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From page 122... ...
The IOM committee, addressing itself to these medical and scientific societies, urges them to accept as a continuing obligation the identified tion and nomination of individuals to the pool of potential FDA advisory committee members. External endorsement, however, should constitute only input to the FDA; it should not involve the review of nominees or selection of candidates.
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From page 123... ...
CONSUMER MEMBERS The FDA seeks two types of consumer participation in its technical advisory committees nonvoting consumer representatives for its CDRH advisory panels and consumer-nominated, technically qualified members for its CDER and CBER committees. FDA regulations list as a standard that an advisory committee must meet Whenever feasible, or required by statute, [a committee]
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From page 124... ...
It does so both for the CDRH nonvoting consumer representatives and for the CDER and CBER consumer-nominated, technically qualified voting members. The OCA is assisted in this process by a consortium of consumer organizations that identifies and evaluates individuals who are technically qualified to serve on FDA technical advisory committees and who also have ties to consumer organizations.
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From page 125... ...
Furthermore, no private individual or organization should be given the right to screen nominations from other sources on behalf of the agency. APPOINTMENT AUTHORITY Until early 1991, the Secretary of Health and Human Services appointed members of FDA technical advisory committees.
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From page 126... ...
The IOM committee recommends that the job descriptions of the I1) A center, office, and division directors, and of the executive secretaries be expanded to reflect their responsibilities for recruiting, nominating and recommending advisory committee members.
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