5
Committee Membership

FDA regulations differentiate between policy advisory committees and technical advisory committees. This report deals mainly with technical committees. The regulations also distinguish between voting and nonvoting (or representative) members. 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. A general criterion for voting members is that they must have ''expertise in the subject matter with which the committee is concerned'' (21 CFR 14.80(b)(1)-(i)).

The "subject matter" of advisory committees, as indicated elsewhere in this report, pertains to the evaluation of drugs, biologics, and medical devices regarding their safety and effectiveness, including indications and contraindications for use and related issues of labeling, and to broader technical issues of product evaluation, such as specific methodologies for assessing a particular class of therapeutic agents.

In this chapter, we address the criteria for membership, recruitment procedures, appointment authority, and provision for consumer and industry representatives on advisory committees.

NOMINATION CRITERIA

General and Specific Criteria

The range of products that the FDA regulates is extensive, and the expertise it needs is equally great. Consequently, the FDA initiated its advisory committee system as a way to obtain scientific and clinical advice that was not available to it through its professional staff but that was needed



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Food and Drug Administration Advisory Committees 5 Committee Membership FDA regulations differentiate between policy advisory committees and technical advisory committees. This report deals mainly with technical committees. The regulations also distinguish between voting and nonvoting (or representative) members. 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. A general criterion for voting members is that they must have ''expertise in the subject matter with which the committee is concerned'' (21 CFR 14.80(b)(1)-(i)). The "subject matter" of advisory committees, as indicated elsewhere in this report, pertains to the evaluation of drugs, biologics, and medical devices regarding their safety and effectiveness, including indications and contraindications for use and related issues of labeling, and to broader technical issues of product evaluation, such as specific methodologies for assessing a particular class of therapeutic agents. In this chapter, we address the criteria for membership, recruitment procedures, appointment authority, and provision for consumer and industry representatives on advisory committees. NOMINATION CRITERIA General and Specific Criteria The range of products that the FDA regulates is extensive, and the expertise it needs is equally great. Consequently, the FDA initiated its advisory committee system as a way to obtain scientific and clinical advice that was not available to it through its professional staff but that was needed

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Food and Drug Administration Advisory Committees 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." Diversity Objectives 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 *   The Industry Liaison Panel, which advised the committee, strongly emphasized this viewpoint.

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Food and Drug Administration Advisory Committees reflect legitimate policy objectives of a pluralistic society that are well founded, appropriate, and designed to ensure a range of viewpoints on what are seldom purely technical issues. The committee believes that it is impractical and undesirable to consider retreating from these general goals. In composing an advisory committee, the FDA has traditionally followed Department of Health and Human Services (DHHS) policies, which aim at a target committee roster composed of 20 percent women and 10 percent minorities. The IOM committee recognizes that the agency, some advisory committee members, and some external observers regard these goals as onerous and tending, on occasion, to undermine the quest for scientific and clinical excellence. There are reports that staff of the three centers* spend considerable time and effort in identifying and recruiting individuals who represent these demographic characteristics and that some individuals with greater expertise may be excluded as a result. This particular recruitment problem has several sources. Historically, it stems from the relatively few women and minority members of medical and scientific professions, especially in highly specialized fields. 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. Women and minorities may be underrepresented in the leadership of professional societies, where peer contact is established and maintained, and in the professional literature, both of which are used extensively by the FDA in seeking candidates for advisory committee vacancies. The IOM committee believes that meeting FDA's diversity goals may require special efforts by the agency to identify women and minority group members who are scientific and medical experts. The IOM committee recommends that the FDA continue its policy of actively seeking qualified women and members of minority groups as potential candidates for advisory committee membership. *   These are the centers for Drug Evaluation and Research (CDER), for Biologics Evaluation and Research (CBER), and for Devices and Radiological Health (CDRH). **   The low acceptance rate problem seems to be a particularly pernicious issue and one that is not peculiar to women and minority candidates.

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Food and Drug Administration Advisory Committees The FDA should waive this policy, however, in those infrequent cases in which the number of women and minority candidates in a field is so limited that it is not feasible to expect to be able to recruit them to serve on a committee. Some constraints may limit the access of the Food and Drug Administration to scientific and technical competence as it seeks to meet its diversity objectives. Current policy of the DHHS prevents an individual from serving concurrently on more than one Public Health Service advisory committee without a special departmental waiver. This policy limits the expertise that can be tapped for a particular committee and impedes meeting diversity objectives. Thus, for example, some highly qualified individuals who may be serving on National Institutes of Health (NIH) study sections are precluded from service on an FDA advisory committee, and vice versa. 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 recommends that the Food and Drug Administration exhaust other means of recruitment before it resorts to selecting persons who serve on other advisory committees. Balance The Federal Advisory Committee Act (FACA) requires that advisory committee membership be "fairly balanced in ... the points of view represented and the functions to be performed" and that there be "appropriate provisions to assure that the advice and recommendations of the advisory committee will not be inappropriately influenced by ... any special interest, but will instead be the result of the advisory committee's independent judgment" [FACA §5(b)]. This criterion, however, provides little operational guidance to the nomination and selection of members to serve on committees like those at FDA. This "balance" requirement, as a practical matter, cannot be easily applied to FDA technical advisory committees, because it contemplates balancing known or assumed divergent views. Achieving fair balance, for example, on a labor-management relations advisory committee, would lead to the appointment of representatives of both industry and organized labor. For technical advisory committees responsible for advice on a wide and unpredictable range of issues, the solution is less obvious. In the case of technical advisory committees, "balance" should be interpreted as a mix of relevant scientific disciplines and a diversity of

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Food and Drug Administration Advisory Committees scientific views. The critical skills may sometimes be broad, at other times narrow and deep; they may be the added experience and wisdom of senior figures in a field, in addition to technical expertise, or the energy and willingness to examine technical data in great detail characteristic of junior "workhorses." At times, they may require experience in the design and conduct of clinical trials, or the analysis and interpretation of data, as well as knowledge of patient care. At other times, elusive "committee skills" may be needed to ensure the effective performance of an advisory committee. The balance of viewpoints required on a given advisory committee cannot be specified easily in advance of a specific meeting agenda. Consequently, a general commitment to expertise and excellence, limited only by legitimate "diversity goals," is appropriate as a statement of agency policy. The IOM committee believes, and court decisions now support, that it is ultimately the Commissioner's responsibility to see that such balance is achieved. The IOM committee considered the wisdom of recommending that "balance" be interpreted as committee membership that included representatives (or advocates) of specific constituencies, irrespective of scientific competence. 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 constituencies. 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. Implications Three implications flow from the above discussion. First, the FDA should formally organize the recruitment of advisory committee members in a systematic, aggressive way (not simply in a passively formal and variably active informal way as at present). Second, recruitment should be oriented toward increasing the pool of potential advisory committee members from which candidates are selected, rather than simply filling vacancies. Third, in the absence of detailed specific selection criteria, and the ability of this or any other committee to design such criteria, it is imperative that advisory committee member recruitment be given the sustained, continuing attention of agency professionals from the Office of the Commissioner down through the centers, offices, and divisions responsible for product evaluation. Executive secretaries should be deeply involved in recruitment, as many of

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Food and Drug Administration Advisory Committees them are now, but the recruitment function should not be delegated exclusively to them. The issue of balance arose in the IOM committee's Industry Liaison Panel recommendation that the composition of a given advisory committee be tailored to the expertise required by a specific meeting's agenda. These "custom tailoring" possibilities are now open to the agency as a result of the rechartering of advisory committees in all three centers. The advantages and disadvantages of this approach are discussed in detail in Chapters 7 and 8; they are not considered here because they do not affect the recommendations on member recruitment. RECRUITMENT PROCEDURES The FDA currently recruits advisory committee members through a mix of formal and informal means. FACA defines the formal procedure, which involves an annual Federal Register notice (21 CFR 14.80(b)(1)(i)). 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. The Federal Register notice requests nominations for voting members to fill these vacancies and for candidates for potential vacancies. Any interested person or group, including industry, may nominate one or more individuals. The regulations require that a nomination specify the advisory committee for which the nominee is recommended, include a complete curriculum vitae of the nominee, and state that the nominee is aware of the nomination, is willing to serve, and appears to have no conflict of interest that would preclude membership. Although few advisory committee nominees and fewer members result from the Federal Register process, it is the only existing agency-wide formal mechanism for identifying and recruiting a pool of potential nominees. Most nominations result from informal processes. Interviews with the CDER, CBER, and CDRH division and office directors and executive secretaries identified the following sources of nominees: Recommendations by professional societies. Contacts made by FDA staff at professional society meetings. Referrals by former or outgoing FDA advisory committee members (not limited to a particular committee, FDA division, or center). Personal inquiries by an FDA professional based on his or her knowledge of experts in a particular field. Identification of experts in the medical literature.

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Food and Drug Administration Advisory Committees Many variations exist in the informal recruitment processes discussed above as a result of the different approaches of particular FDA recruiting officials and the absence of any clear agency-wide policy beyond the Federal Register notice. The IOM committee recommends that the FDA adopt an agency-wide recruitment policy and develop a more systematic approach to seeking nominations on a continuing basis for potential advisory committee membership. The agency should actively seek nominees from many sources—academic medicine, professional societies, other government agencies, industry, and consumer and patient organizations. It should not rely solely on its own staff for such nominations. Each center should develop and periodically update a pool of qualified candidates, rather than simply seek nominations to fill vacancies. The FDA should use multiple approaches to develop these candidate pools, including use of the NIH-Alcohol, Drug Abuse, and Mental Health Administration computerized file (as well as maintenance and updating of this data base); creation of an FDA computerized data base; routine nominee solicitation of current and former advisory committee members, professional medical and scientific societies, medical school deans and department chairmen, industry, and interested consumer and public interest organizations. The FDA should explore avenues for seeking nominations such as announcements in the Journal of the American Medical Association, the New England Journal of Medicine, and specialty journals. Routine solicitation could be extended to identify candidates for consultancies as well as advisory committee members. In addition to aggressively seeking nominations from medical and scientific societies, the FDA should seek to enlist these organizations in the routine support of the advisory committee nomination process. The IOM committee, addressing itself to these medical and scientific societies, urges them to accept as a continuing obligation the identification 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. The NIH Office of Research on Women's Health and similar organizations should be routinely solicited for nominations. Professional society groups, such as the Women in Nephrology of the American Society of

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Food and Drug Administration Advisory Committees Nephrology, should also be enlisted in this effort. Working groups of women and minority medical science experts should be routinely asked to identify candidates for the pool. The IOM committee disagreed with the recommendation of the Industry Liaison Panel that "an impartial group, such as the Institute of Medicine, [should] review proposed additions to the drugs and biologics advisory committee roster to ascertain that all individuals are, indeed, recognized as experts by their peers." (The Lasagna Committee advanced a similar recommendation.) Rather, the IOM committee believes that the recruitment of potential candidates and the nomination and the appointment of members are functions that should be exercised by the FDA and that the agency should be held accountable for their effective performance. It understands its needs for advice better than any external organization. The responsibility for implementing these steps within the FDA should not be delegated by neglect solely to executive secretaries. Although these individuals may well do the lion's share of the work in recruiting advisory committee members, the Commissioner of Food and Drugs should issue clear guidance to all FDA staff that the responsibility must be discharged at the center, office, and division levels as well. 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] include representatives of the public interest" (21 CFR 14.40(f)(5)). Although the regulations are silent on the meaning of "representatives of the public interest," they later state (21 CFR 14.80(b)(2)) that the Commissioner shall, when required by statute, and may when not required by statute, provide for nonvoting members of a technical advisory committee to serve as representatives of and liaison with interested organizations [emphasis added]. Nonvoting members—(i) Shall be selected by the interested organizations, as provided in 14.84; technical expertise in the subject matter with which the committee is involved is not a requirement; and (ii) May be special Government employees subject to the conflict of interest laws and regulations, except as provided in 14.84(e).

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Food and Drug Administration Advisory Committees The procedures for nomination and selection of nonvoting members of standing technical advisory committees are specified in 21 CFR 14.84. The "rights and responsibilities" of these members are delineated in 21 CFR 14.86. There are no nonvoting consumer or industry representatives who serve on drug or biologics advisory committees. In the 1970s, nonvoting consumer representatives served on drug advisory committees, but there were no industry representatives. These nonexperts were often unable to participate in committee deliberations. Consequently, the then-Bureau of Drugs decided on a different approach. It now seeks consumer-nominated individuals who are technically qualified to serve as voting members of drug and biologics advisory committees. All drug and two of four biologics advisory committees now have such members. The Medical Device Amendments of 1976 required that all advisory committees or panels include one nonvoting consumer representative and one nonvoting industry representative. In accordance with 21 CFR 14.80(b)(2), these individuals are to represent interested organizations and provide liaison to the advisory committee. These nonvoting members are not required to be expert. The IOM committee considered and rejected the extension of the statutorily required CDRH approach of nonvoting consumer and industry representatives, but it also chose not to recommend modification of the device provision of the law. Currently, the FDA Office of Consumer Affairs (OCA), which is responsible for seeking consumers to serve as advisory committee members, solicits nominations from a number of sources. 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. Along with other interested parties, the consortium nominates individuals for appointment both as qualified voting members of CDER and CBER committees and as consumer representatives of CDRH panels. The consortium's principal role is to interview consumer nominees on behalf of FDA and evaluate their qualifications. In seeking nominees from consumer organizations, the FDA should continue to solicit nominations from the consumer consortium, but it should also reach out to other interested parties. In the judgment of the IOM committee, the practice of allowing any outside organization to screen (and thus to screen out) nominees from other sources is unsound. In addition, the IOM committee believes that the concept of "consumer"—both for consumer-nominated members and medical device consumer

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Food and Drug Administration Advisory Committees representatives—should be expanded to include patients or patient-nominated individuals, whose viewpoints can be valuable in the product evaluation process. The IOM committee believes that consumer input to the deliberations of FDA technical advisory committees can be quite valuable. It recognizes that there are various ways to obtain such input, especially through public testimony by consumers or patients as appropriate to the specific agenda. The IOM committee recommends that the FDA actively seek technically qualified nominees from consumer organizations and other interested parties for all of its technical advisory committees and panels. Selection, however, should require evidence of scientific and technical qualifications. The committee also recommends that the concept of "consumer" be expanded to include patient and patient-oriented organizations. 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. This sometimes resulted in nominees who may not have been scientifically qualified or who were selected to bring a politically preferred view on scientific and regulatory matters before the FDA. Following enactment of the Food and Drug Administration Revitalization Act of 1990, the Commissioner has appointed advisory committee members, but he remains under an obligation to send nomination packages to the Office of the Secretary 10 days in advance of any appointment. The IOM committee believes that vesting power to appoint committee members in the Commissioner constitutes a substantial step forward in both expediting the appointment process and ensuring that such appointments are responsive to the specific scientific and technical needs of the agency. The IOM committee commends the Office of the Secretary for its concurrence that the Revitalization Act vests formal authority to appoint advisory committee members in the Commissioner of Food and Drugs. ADMINISTRATIVE RESPONSIBILITY FOR APPOINTMENTS The Commissioner, under his authority to appoint advisory committee members, should clearly indicate to all FDA staff that center directors, office

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Food and Drug Administration Advisory Committees and division directors, and executive secretaries share responsibility for recruiting qualified advisory committee members. Nominations to the Commissioner should come from the center directors. The IOM committee recommends that the job descriptions of the FDA center, office, and division directors, and of the executive secretaries be expanded to reflect their responsibilities for recruiting, nominating, and recommending advisory committee members.