8
Organization and Management

The IOM committee was asked to consider ways of improving FDA management of, and accountability with respect to, the advisory committee system. In this chapter, the committee examines several issues of organization and management of FDA advisory committees that have been raised by this study. Many of these issues have surfaced in prior reports. In 1990, for example, the Lasagna Committee report recommended "a fundamental restructuring of [the advisory committee] system. The committees should have their own independent staff and should be appointed by, and report directly to, the Office of the FDA Commissioner [emphasis added]."

The Industry Liaison Panel recommended a somewhat different approach:

We believe that the committee system must be enlarged, that more formal training of committee members and executive secretaries should be instituted, and that guidelines should be developed so that each FDA Division operates its committees under the same principles. To accomplish this a strong central office for committee management is required. To assure uniformity and adherence to established policies, this office should handle both drugs and biologics. The industry liaison panel feels that statutory differences between drugs and biologics on the one hand and medical devices on the other are such that it may be more appropriate for medical devices to be managed separately [emphasis added]. However, many of the policies, procedures and training programs would be applicable to medical devices as well as drugs/biologics. The industry liaison panel recommends that uniform procedures be utilized where possible.

These different proposals, along with other inputs received by the IOM committee, highlight the need to address issues of organization and management. This chapter, therefore, considers the management of the



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Food and Drug Administration Advisory Committees 8 Organization and Management The IOM committee was asked to consider ways of improving FDA management of, and accountability with respect to, the advisory committee system. In this chapter, the committee examines several issues of organization and management of FDA advisory committees that have been raised by this study. Many of these issues have surfaced in prior reports. In 1990, for example, the Lasagna Committee report recommended "a fundamental restructuring of [the advisory committee] system. The committees should have their own independent staff and should be appointed by, and report directly to, the Office of the FDA Commissioner [emphasis added]." The Industry Liaison Panel recommended a somewhat different approach: We believe that the committee system must be enlarged, that more formal training of committee members and executive secretaries should be instituted, and that guidelines should be developed so that each FDA Division operates its committees under the same principles. To accomplish this a strong central office for committee management is required. To assure uniformity and adherence to established policies, this office should handle both drugs and biologics. The industry liaison panel feels that statutory differences between drugs and biologics on the one hand and medical devices on the other are such that it may be more appropriate for medical devices to be managed separately [emphasis added]. However, many of the policies, procedures and training programs would be applicable to medical devices as well as drugs/biologics. The industry liaison panel recommends that uniform procedures be utilized where possible. These different proposals, along with other inputs received by the IOM committee, highlight the need to address issues of organization and management. This chapter, therefore, considers the management of the

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Food and Drug Administration Advisory Committees advisory committee system, the compensation of advisory committee members, their orientation and training, and suggestions that FDA create advisory committees in addition to its technical committees. SYSTEM MANAGEMENT The IOM committee, as it examined ways to improve the management and accountability of the advisory committee system, concluded that a necessary part of its work was to consider how the FDA currently supports and manages this system. It found few prior reports or current assessments that identified the key FDA players and specified their respective roles. This section considers the relationships among advisory committees and the Commissioner and his office, the center directors, the office and division directors responsible for product evaluation, and the executive secretaries. Its purpose is to clarify the roles of these respective officials in advisory committee management. The Commissioner and His Office FDA advisory committees are formally chartered by the Commissioner of Food and Drugs to advise him in the discharge of his responsibilities related to ensuring the safety and effectiveness of drugs, biologics, and medical devices for human use. Thus, the de jure reporting relationship of advisory committees to the Commissioner is not in question. The IOM believes that the authority to create technical advisory committees should be vested in the Commissioner of Food and Drugs (and not in any higher official) and that the formal reporting responsibility of advisory committees to the Commissioner is appropriate. However, as a practical matter, it is not feasible for committees to convey their advice to the Commissioner directly, save on a few occasions of his choosing. Commissioner Kessler, who may have attended more advisory committee meetings than any of his predecessors (perhaps more than all of them together), indicated at the initial meeting of the IOM committee that it was not feasible for advisory committees to report directly to him on a regular basis. Advisory committees usually report to the director of the product evaluation office and to the director of the responsible reviewing division, the significance of which is examined below. What is the role of the Commissioner? The IOM committee believes that the Commissioner must set the tone for all agency personnel regarding the importance attached to the effective performance of FDA advisory committees. He should also communicate forcefully to advisory committee members themselves, to academic medical scientists, and to the regulated

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Food and Drug Administration Advisory Committees industries, both formally and through all informal means available, the importance that the FDA attaches to this form of public service, which benefits the public health of the nation. The IOM committee has also concluded that the Office of the Commissioner has a distinct role to play in the FDA advisory committee system. The advisory committee system has increased in use, in importance, and in public visibility in recent years. Moreover, enough controversies involving advisory committees have occurred in the past two years to justify continuing attention by the Office of the Commissioner. During this time, however, there has been no high-level official in the Office of the Commissioner with a designated responsibility for agency-wide policy and management guidance for advisory committees. The IOM committee concludes that this deficiency should be remedied. There are three units in the Commissioner's office involved in advisory committee matters, two with administrative responsibilities, and one in policy. The Office of Committee Management prepares the annual report on advisory committees that is required by the Federal Advisory Committee Act (FACA). The Division of Ethics and Program Integrity, as discussed in Chapter 6, reviews initial committee nominations for conflict of interest and also processes conflict waiver requests. Neither entity provides, nor is equipped to provide, policy guidance to the various centers with respect to the advisory committee system. The advisory committee functions of each should be consolidated under the authority of the policy official recommended here. The Office of the Ombudsman, however, has been recently created (1990) within the Commissioner's office. It deals with specific complaints involving, among other subjects, advisory committees. The Ombudsman has also been responsible for product jurisdiction and combination product regulations, the related intercenter agreements, and the rechartering of CDER and CBER committees that resulted. Early in his tenure, Commissioner Kessler initiated a reorganization that included the creation of five deputy commissioners (or their equivalent) in the Commissioner's office. These were deputies for operations, policy, and external affairs, a senior adviser for management, and a science adviser to the Commissioner. Notably, the directors of all FDA centers, including those for drugs, biologics, and medical devices, now report to the Deputy Commissioner for Operations. What advisory committee system functions might be performed by the Office of the Commissioner? In the judgment of the IOM committee, a need exists for clear policy and management guidance to the FDA advisory committee system from the Commissioner regarding the role, importance, and general operations of advisory committees in the work of the agency.

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Food and Drug Administration Advisory Committees Specifically, the following potential tasks might be considered as appropriate: monitor the performance of the advisory committee system for the Commissioner; exercise leadership in standardizing committee procedures and reducing unjustified variation wherever feasible; coordinate agency-wide advisory committee functions; oversee the computerization of committee processes; monitor charges of ''undue influence'' of FDA over advisory committees; articulate policy and monitor performance of the recruitment of advisory committee members, especially women and minorities; coordinate conflict-of-interest policies and procedures affecting advisory committees on behalf of the Commissioner, and negotiate with the DHHS Office of the Special Counsel for Ethics and the Office of Government Ethics on the agency's behalf; review all existing regulations, forms, and implementing documents pertaining to advisory committees and revise them as appropriate; revise and update the Staff Manual Guide; and exercise leadership in the development and implementation of an orientation and training program for the advisory committee system. The above functions deal with policy and management issues; they are not intended to involve the day-to-day operations of the advisory committee system. The IOM committee regards the specific organization of the Office of the Commissioner as the province of the Commissioner. However, given that all FDA centers, including the three of concern in this study, report to the Office of the Deputy Commissioner for Operations, it regards this office as the most likely location for a high-level advisory committee function. The IOM committee recommends that a high-level official in the Office of the Commissioner of Food and Drugs be assigned primary responsibility for developing, disseminating, enforcing, and monitoring administrative policy and management guidance to the advisory committees of the three centers. Center Directors The current directors of the three centers all strongly support the advisory committee system, although their involvement in the work of the

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Food and Drug Administration Advisory Committees committees varies. The roles of the center directors are not spelled out with respect to advisory committees, however, and the IOM committee has concluded that this kind of clarification would be useful. What functions might center directors be formally expected to carry out with respect to advisory committees? The following are important: ensure implementation in their respective centers of agency-wide policy toward advisory committees developed in cooperation with the Office of the Commissioner; monitor the recruitment of advisory committee members for expertise, external endorsement, and special efforts to recruit women and minority members; review all "custom tailoring" advisory committee meetings that involve matching the composition of the committee to the technical requirements of an agenda to avoid charges of "undue influence"; help design an orientation and training program along the lines recommended below; examine issues that may arise in the work of one or several advisory committees that may cut across the work of the entire center and require consideration on a broader basis than a single committee (or division) can provide; and support innovation in the use of advisory committees. Office and Division Directors The role of advisory committees cannot be specified clearly without clarifying the management responsibility for advisory committees within the FDA. The executive secretaries are often identified as the key FDA officials responsible for advisory committees. Although this is true for administrative support purposes, it is not generally true for the substantive work of the committees. Authority for product approval of new drugs, biologics, and medical devices is vested in the Commissioner, then delegated to other FDA officials. In CDER, authority is delegated to the center director, then to the directors of the two offices of drug evaluation; in the case of oncology drugs, the delegation is one step downward to the division director for oncology and pulmonary drug products. The working responsibility for product evaluation and operational responsibility for approval resides within the three centers at the level of the division director. Thus, in substantive terms, the primary responsibility for management of advisory committees resides with division directors.

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Food and Drug Administration Advisory Committees Advisory committees exist to provide independent expert advice to the FDA, primarily to the FDA officials who approve or disapprove applications. It is important, therefore, to clearly state that the relationship between office and division directors, on the one hand, and advisory committees, on the other, must be a comfortable, productive working relationship based on mutual respect and a commitment to scientific assessment of new therapeutic products. Clarifying this relationship is important both for internal administrative purposes and for external "consumption." The role of the division directors in advisory committee management should include, at a minimum, involvement in the recruitment of advisory committee members, preparation of the committee agenda (with the advisory committee chair), and preparation of the specific questions that the committee is asked to consider (also with the chair). Executive Secretaries Executive secretaries have both administrative and substantive roles to perform in the advisory committee system. The primary administrative role should be to promote the efficient performance of an advisory committee. (By extension, the organization of the executive secretariat should be to promote the efficient operation of the system.) Specific functions of executive secretaries include recruiting committee members and preparing nomination packages; administering conflict-of-interest reviews on initial appointment and processing waivers for specific meetings; arranging meeting logistics (whether on an internal or contract basis); distributing materials to advisory committee members; and following up committee meetings. The administrative work of the executive secretaries intersects with the substantive agenda that the reviewing offices and divisions wish to bring before an advisory committee. This may involve participation in formulating the agenda of a given advisory committee meeting, determining the appropriate sponsor and FDA materials to be sent to the committee, and preparing the questions that the committee is being asked to consider. Currently, CDER is organized with most executive secretaries assigned to a central unit but with some assigned to reviewing divisions. CBER also has a central executive secretariat. CDRH assigns professionals from reviewing divisions to serve, in addition, as executive secretaries. Executive secretaries in CDER and CBER are engaged in the support of advisory committees on a full-time basis. CDRH executive secretaries, however, are usually professional staff involved in product evaluation; thus, they are engaged in the substantive work of advisory committees, as well as providing administrative support.

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Food and Drug Administration Advisory Committees Given these administrative and substantive responsibilities, the Industry Liaison Panel recommended a dual reporting arrangement whereby the executive secretaries report to a centralized unit within each center for administrative support of advisory committees and also to the directors of the reviewing divisions for substantive support. The IOM committee concurs in this recommendation. The organization of the executive secretaries is an issue that has a long history within FDA, the focal point of which has been the centralization of the executive secretariat. The term has several meanings. One meaning is centralization at the level of the three respective centers, which is the prevailing pattern. A second meaning is a consolidated committee management staff that serves both drugs and biologics, while leaving CDRH with its distinctive system of committee management. Finally, the term centralized can be extended conceptually to include CDER, CBER, and CDRH, although this has never been done and has not been seriously advocated. Historically, the second meaning derives from 1982 when the organizational units responsible for drugs and biologics were merged into a single center. A centralized committee management staff was created at that time, and this arrangement continued beyond the 1987 reorganization that split drugs and biologics into CDER and CBER. In 1991, the committee management unit was finally split into separate units for the respective centers. The IOM committee believes that the primary function of the center-based executive secretariat should be to provide the administrative and logistical support of advisory committees. Efficiencies can be achieved as executive secretaries learn from each other. However, the argument for a consolidated CDER and CBER unit rests, in part, on a philosophy that an executive secretariat should have some autonomy from the reviewing divisions and should be responsible for managing the advisory committee system to ensure the independence of the advice provided by advisory committees. The IOM committee believes that guaranteeing the independence of the advice provided by advisory committees cannot be done through the executive secretariat, however it may be organized. Rather, it requires the diligence of center directors and policy oversight by the recommended high-level official in the Office of the Commissioner. The IOM committee recommends that the executive secretaries report to a central unit in their respective centers for the purpose of providing administrative support to that center's advisory committees. It also recommends that they report to the appropriate division directors to provide program support to the committees.

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Food and Drug Administration Advisory Committees In general, the IOM committee believes that a clarification of the roles of all FDA officials responsible for the advisory committee system is long overdue. The objective of this clarification should be to ensure that advisory committees provide the independent expert advice that the agency requests and needs. The IOM committee recommends that the roles and responsibilities of all FDA officials involved in the advisory committee system be clearly articulated in agency policy that is widely distributed to FDA professional staff, advisory committee members, and other interested parties. The committee further recommends that the job descriptions of all officials be changed to reflect their respective responsibilities. COMPENSATION The authority to set the daily rate of compensation for FDA advisory committees resides with the Commissioner of Food and Drugs. He is subject to four constraints—two legal, one budgetary, and one administrative. The statutory limit on compensation for all federal government advisory committee members is the daily rate for a Senior Executive Service IV position, currently $429.50 per day. Regulations of the General Services Administration further limit the daily rate to that of a GS-15 in the General Schedule, currently $320 per day, unless the agency head personally determines that a higher rate "is justified and necessary." The budgetary limit is the obvious requirement that an agency head must have funds to cover the costs of whatever rate is adopted. Although agency heads have authority to set rates for the members of the committees that advise them, FDA's status as a part of the Public Health Service also limits that authority. As a practical matter, no single PHS agency can pay advisory committee members at rates much higher than those of the other agencies. Currently, the Centers for Disease Control pays committee members $188 per day, the National Institutes of Health pays $150 per day, and the FDA pays $150 per day.* *   In 1965, advisory committee members for drugs and biologics were paid $128.80 per day. This rate was lowered in 1984 to $100; it was raised to $150 in February 1990. Device committee members were paid $128.80 per day from 1972 until this rate was raised to $150 in 1990. Using the Consumer Price All-Items Index to inflate and deflate these figures, the $128.80 fee translates into $572.67 in 1992 dollars; conversely, $150 in 1992 dollars is the equivalent of $33.63 in 1965 terms. Members of the Edwards Committee, incidentally, who were appointed by the Secretary of Health and Human Services in 1990 to advise on matters pertaining to the FDA, were paid approximately $300 per day.

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Food and Drug Administration Advisory Committees FDA advisory committee members are paid only for those days on which they attend a meeting. The agency is barred by regulation from paying them for homework for normal meeting preparation, even though an individual may spend five days or more in preparation. However, CDRH does compensate individual advisory committee members for homework if they conduct an "agency-directed assignment" that results in a tangible end product, usually a report, that is not the end product of the advisory committee. Typically, this involves using members as primary reviewers of applications. Neither CDER nor CBER compensates committee members for homework. FDA regulations also permit payment to advisory committee members at the daily rate for travel time that involves 50 percent of an additional day beyond the meeting and that results in the loss of some regular compensation. However, no use is made of this authority. The IOM committee believes that all Public Health Service advisory committee members are underpaid, including those who advise the FDA. This is clearly true with respect to the maximum daily rate allowed by law and GSA regulations. It is also true with respect to the opportunity cost to members of foregone consulting fees from drug or device firms of $1,000 a day or more. Moreover, younger members in academic medicine often confront the perception that service on an FDA committee carries less academic reward than that of an NIH study section. The IOM committee believes that public service should be adequately compensated, although obviously not at the rates found in the private sector. It is concerned that the current meager rate of compensation may dissuade some individuals from serving as FDA advisory committee members and may diminish the incentive to others to prepare adequately for meetings. In general, the IOM committee is concerned that these rates do not adequately reflect the value that FDA and the general public attach to the important work performed by advisory committee members. The IOM committee recommends that the Commissioner, with the Secretary of Health and Human Services, review the adequacy of compensation for Public Health Service advisory committee members, including FDA advisory committee members, and take appropriate steps to maintain daily rates in relation to increases in the federal salary schedule. It further recommends that CDER and CBER, to the extent that they use primary reviewers for applications presented to advisory committees, compensate these reviewers, as CDRH currently does, for "agency-directed" homework.

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Food and Drug Administration Advisory Committees The IOM committee notes that legislation enacted in October 1992 authorized the FDA to charge user fees for product evaluation. Under this new authority, it may be appropriate for the FDA to review the compensation of advisory committee members in relation to their contribution to product evaluation. ORIENTATION AND TRAINING Insufficient orientation of advisory committee members is a recurring complaint. It was raised by the Industry Liaison Panel report and in the interviews of current and former advisory committee members conducted by a working group of the IOM committee. Many—perhaps most—of these past and present advisory committee members felt that their training and orientation had been inadequate. Several still had only a vague knowledge of the structure of the FDA and the committee's relation to it—which raises questions about their understanding of their roles and responsibilities. Some suggested a more formal orientation (perhaps using audiovisual materials and a new orientation manual), and a significant number argued for a clearer statement of the committee's role in FDA functions. Among the critical comments of those interviewed were these: "It's like being a trial lawyer without ever being in the courtroom!" and "[Orientation was a] 30-minute phone call and a written folder." There were also, however, some positive comments: ''I feel that the training and orientation session was superb. It may be reasonable to repeat some of the basic principles periodically.... [For new members] I might suggest ... that there also be direct contact with the immediate predecessor." The following were among the specific recommendations for improving orientation of committee members: A one-day training session for new members before the meeting of an advisory committee. Having new committee members attend a meeting before becoming an active advisory committee member. An hour-long closed session to introduce new members to the issues. This should be at the first meeting of the new group and should include seasoned committee members so that they can answer any questions raised by new members. The training and orientation of advisory committee members and agency staff were addressed in both the Dorsen report (1977) and the McMahon report (1982). Both studies found, after interviewing committee members and FDA staff, that a lack of preparatory information led to frustrations

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Food and Drug Administration Advisory Committees among committee members. Furthermore, because of a lack of advance information about the precise duties of members of advisory committees, many experienced disappointment as they discovered that certain decisions required of the committees could be more mundane than they had originally expected. The need for a systematic orientation program is generally recognized throughout the agency. Among advisory committee members, one encounters the belief that a more systematic orientation and training program is needed, especially for new members, who reportedly often come to the initial committee meetings without knowing what is expected of them or how FDA exercises its regulatory responsibilities. As a result, they are not always prepared to play an effective role until well into their term. The need for orientation and training appears to be widely recognized; what, then, has been the agency response? One response was the preparation of a handbook entitled FDA Public Advisory Committees: A Handbook for Advisory Committee Members and the Executive Secretary, which is routinely distributed to prospective CDER and CBER advisory committee members. Some committee members have reported to agency staff, however, that the handbook does not provide them with the background they need to perform their tasks. CDRH has prepared a videotape on the duties and responsibilities of advisory panel members and distributes it to all of its prospective committee members. Responsibility for training advisory committee members is decentralized to the respective centers, usually to individual executive secretaries or committee management staff. The staff of the three centers do not meet to discuss the training needs of committee members or to collaborate in developing orientation programs. Moreover, neither the Division of Human Resources Management, which designed FDA's training programs until about 10 years ago, nor the training staffs of the centers have been involved with the orientation of advisory committee members. Consequently, orientation varies greatly between centers and often within a given center—from day-long and half-day orientation sessions to committee member "apprenticeships" as consultants and "on-the-job" training of members. In CDER, no single individual supervises the orientation of advisory committee members. Each committee's executive secretary is responsible for whatever orientation is provided. Although the executive secretaries who are part of the Advisors and Consultants Staff share information on how to orient new members, there are no meetings of all CDER executive secretaries to discuss orientation or to develop a consistent CDER approach. However, all prospective committee members are given written information on conflict of interest. The handbook, relevant regulations, and committee

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Food and Drug Administration Advisory Committees charters are often included in the orientation packages prepared by individual executive secretaries, and division-specific materials are sometimes also provided to new members. But there is no standard set of materials provided to new members. Direct personal orientation of advisory committee members is also left to the discretion of the executive secretaries. (One CDER executive secretary expressed the view that the interests of the members of CDER's 17 advisory committees varied too much to hold one orientation session.) Several approaches are used. If a number of members at a given advisory committee meeting are new, part of the meeting may be closed for orientation. Another option is to hold an orientation session the evening before an advisory committee meeting or to ask a single new member to stay an extra day after a meeting. CBER's two executive secretaries are also responsible for orienting new committee members. In March 1992, however, its Division of Scientific Advisory Committees conducted a pilot orientation session to improve its orientation program, which was attended by new members from all four CBER advisory committees. This program is still in its formative stages and, as currently planned, consists of a morning plenary session that covers topics of interest to all committee members (e.g., ethics, proprietary information, personal liability, etc.) and a specialized afternoon session for each committee for its own new members. It has not been decided whether to schedule sessions the day before a new member's first advisory committee meeting or to hold a separate event for all new members. Of the three centers, CDRH has the most structured orientation program for new advisory committee members. Like CDER and CBER, new advisory committee members receive written materials that explain their responsibilities. In addition, however, the Advisory Panel Coordinator (APC) within the Office of Device Evaluation asks an executive secretary in advance of a panel meeting if there are any new members located in the Washington, D.C., area. Currently, cost prohibits bringing in out-of-town panel members for orientation. If so, an orientation session will be scheduled for these individuals, and the other executive secretaries will be asked to identify new panel members in the area who should also attend. The purpose of the training is to discuss the relationship of the written materials provided to the new panel members to the CDRH regulatory context. In this way, panel members can focus their attention in the most productive and appropriate way possible. The two-hour orientation session is sometimes scheduled immediately before a panel meeting begins or sometimes on the previous day. The CDRH executive secretaries provide feedback to the APC from both the divisions and the panel members. If

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Food and Drug Administration Advisory Committees either sees deficiencies in the orientation, the executive secretaries convey that information to the APC. CDRH has also prepared three videotape scripts for use in orienting new panel members. These deal with "Mission & Organization"; "Medical Device Approval: The Process & The Panel's Role"; and "Avoiding Conflict of Interest." The idea of training videos for panel members was developed by the Office of Device Evaluation and the Health Industry Manufacturers' Association (HIMA), and scripts were written by a contractor (who was paid $10,000 by HIMA). CDRH provided a great deal of input, and the scripts were approved by the center in 1991. The project is currently on hold while CDRH awaits word on whether HIMA wishes to continue, whether the center has the funds to do so,* and whether their plans will accord with the recommendations of this study. The centers also use other means of orientation. A division will sometimes invite a potential new member to a meeting as a guest to acquaint them with the advisory committee process. Or it may hire the person in a consultant capacity as an "apprentice" committee member, which serves the dual purpose of giving the division an opportunity to evaluate an individual's potential as a committee member and giving the individual some familiarity with the work of a member. What questions deserve attention in considering a more systematic orientation and training program for advisory committee members? First, the rationale for such an effort is straightforward: systematic orientation and training of advisory committee members would fulfill a widely recognized need; it would promote the efficient use of committee members' talent; it would establish clear expectations for members about their roles and responsibilities; and it would permit agency officials to explicitly acknowledge the important public service contribution of advisory committee service. In addition, were the program agency-wide, it might encourage "soft standardization" across the three centers. It would do so by promoting concern for common problems without overriding the justifiable variation that derives from a particular class of therapeutic or diagnostic entities. If the effort was developed by the Office of the Commissioner in concert with the centers, it would force clarification about how much the content of such a program should be agency-wide, center-specific, or specific to a given division or class of therapeutic products. What should be the content of an orientation program? The answer to this question should be developed by the appropriate FDA staff in conjunction with selected advisory committee members. The content *   Estimates to produce the videos range from $10,000 to 25,000 each, depending on whether professional actors are used.

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Food and Drug Administration Advisory Committees criterion should be what a new member needs to know to be effective as a committee member. It should probably include a description and some history of FDA's statutory regulatory responsibilities; a discussion of the purposes of FDA advisory committees, including how they differ from NIH study sections and other similar committees; a careful and sensitive examination of the conflict-of-interest law and its implementation; and the important public service and public health contribution of advisory committee work. New committee members would also benefit from a discussion of the ''Format and Content' guidelines for submission of a new drug application prepared several years ago by Drs. Robert Temple and Robert O'Neil. A related need is the orientation of advisory committee chairs to their roles, which none of the centers do routinely; their orientation should include FDA policies and procedures regarding electronic coverage of advisory committees (21 CFR 10(200–206)). Furthermore, assuming that recommendations of this report about strengthening the role of committee chairs are accepted, orientation could usefully focus on these enlarged responsibilities. Should the scope of an orientation and training program be restricted to advisory committee members, or should it also include the training of FDA officials who routinely deal with advisory committees? Although the initial emphasis should be on members, a well-designed program should serve both groups. What kind of orientation and training materials should be used? At a minimum, a current orientation manual should be prepared (and maintained) for all advisory committee members. In addition, a videotape should be prepared to capture the views of the FDA Commissioner and relevant high-level FDA officials regarding the importance of the advisory committee function. Finally, a program of face-to-face, one-day sessions should be held for new committee members. Across the three centers, approximately 75 new advisory committee positions become open each year. If an agency-wide program was designed, with content that was agency-wide, center-specific, and division-specific, one or two annual sessions could be organized for all new members from all centers. Potential organizations responsible for conducting an orientation and training program include the FDA Division of Human Resources; center-level units, such as the CDER Staff College or the CDRH training office; an agency-wide effort jointly organized by the three centers; or an external contractor. The specific design is an administrative choice to be made within the agency after the basic parameters of the program have been established.

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Food and Drug Administration Advisory Committees The IOM committee recommends that the FDA establish a systematic orientation and training program that is directed mainly toward new advisory committee members, with a special component for committee chairs, and that will also be useful for current members and for FDA staff who deal with committees. The Office of the Commissioner should exercise leadership in the design of this program, in cooperation with the three centers. The design should consciously search for agency-wide similarities as well as center-specific and division-specific content. The public service and public health contribution of advisory committee membership should be emphasized in this program. TYPES OF ADVISORY COMMITTEES The IOM committee has focused its attention in this report on the technical advisory committees used by the FDA for drugs, biologics, and medical devices. In the course of the study, however, several suggestions have been made that the committee consider other types of advisory committees and these are reviewed briefly in this section. Policy Advisory Committee The first issue was whether the IOM committee should recommend that a policy advisory committee be established to advise the Commissioner on the broad policy issues related to drugs, biologics, and devices that come before the agency. The Lasagna Committee, for example, recommended formation of "a permanent standing Policy and Oversight Committee ... to monitor the agency's needs and performance with regard to regulation of drugs and biologics for humans." It proposed that this committee meet regularly and report to the Secretary of Health and Human Services; and that its members be "knowledgeable national leaders" selected by the Secretary from candidates nominated by the Institute of Medicine. The IOM committee discussed this issue at its December 7, 1991, meeting and again at its meeting on May 29–30, 1992, but on neither occasion was any great enthusiasm for such a committee noted. Instead, the committee observed that the Commissioner of Food and Drugs, like the head of any government agency, does not lack for free advice from many sources. It concluded that the utility of such a policy advisory committee should be determined by the Commissioner, who can ask the Secretary to appoint such a body if it would serve his purposes. The committee did hear a presentation from the newly appointed Science Adviser of the FDA, Dr. Elkan Blout, regarding his plans for the creation of a science board. This board, when chartered, might fulfill some

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Food and Drug Administration Advisory Committees of the functions envisioned for a policy advisory committee to the Commissioner. Other Issues Several other issues were raised late in the IOM committee's study. First, the committee received suggestions that cross-cutting, discipline-based advisory committees (in contrast to the therapeutic class or product-line technical advisory committees) be established for biostatistics, chemistry, pharmacology and toxicology, and biomaterials.1,2 The basic rationale for such an action was that existing committees often raised issues in product evaluations that had broader implications than those related to a given application. No advisory committee exists for aggregating and considering such issues. Currently constituted technical advisory committees focus on product evaluation, broadly construed. The membership of such committees usually includes representatives of several critical, cross-cutting disciplines to provide valuable perspectives; biostatistics is almost always represented; and chemistry and pharmacology\toxicology are sometimes included. However, discipline-based issues that arise within product-oriented advisory committees and that have center-wide or agency-wide implications are not systematically examined. We note, however, that the substantive issues that such committees might address could very well be candidates for technical workshops that the agency, or one of its centers, might sponsor, perhaps drawing participants from the membership of existing advisory committees. Two other issues were raised with the committee. Should each of the three centers have a policy advisory committee? And should CBER establish a "board of scientific counsellors" to review all its intramural research programs and personnel, rather than divide that responsibility as it currently does, among four technical advisory committees? All these issues were raised late in the IOM committee's study. Although they merit discussion and debate, the committee did not have extensive opportunity to consider all of their implications. It regards all of these matters as appropriate subjects for internal FDA discussion and decision. The IOM committee wishes to note that if the FDA adopts its recommendation that the agency establish a high-level position within the Office of the Commissioner for advisory committee policy and management guidance, the framework would exist within which such issues could easily be considered.

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Food and Drug Administration Advisory Committees AGENCY MANAGEMENT AND ACCOUNTABILITY This report makes many recommendations for improving the use of advisory committees by the FDA in the evaluation of drugs, biologics, and medical devices. Throughout the report there are general expressions of concern about agency management and accountability, which may not be captured fully by the report's specific recommendations. Thus, the IOM committee deems it necessary to summarize the latter in relation to these larger considerations. Agency Management In the judgment of the IOM committee, it is important to differentiate between the management of the advisory committee system and the management of the product evaluation process as affected by the advisory committee system. Regarding system management, the IOM committee's most important recommendation is that a high-level position be established in the Office of the Commissioner to provide administrative policy and management guidance to the advisory committee system. Although the precise location of such an office is properly a decision to be made by the Commissioner, an appropriate place may be the Office of the Deputy Commissioner for Operations, to which the directors of the three relevant centers now report. Advisory committees, the IOM committee believes, have become a permanent fixture in the FDA's evaluation of products, and their effective use should be a responsibility of FDA officials at all levels. Improvements in management would flow from clarifying the roles and responsibilities of all officials involved in the advisory committee system from the Commissioner through center, office, and division directors, down to the executive secretaries. Such clarification should include expanding the job descriptions of these officials as necessary. The IOM committee acknowledges the important role of FDA office and division directors in the work of advisory committees; it does not recommend circumventing these officials by proposing to locate operational responsibility for committees elsewhere, but urges clarification of their responsibilities for the effective performance of the system. An orientation program for advisory committee members, which could also be used in training responsible FDA officials, would improve the performance of the entire system. Other management-related recommendations pertain to the recruitment of qualified members and establishment of a pool of potential members; greater involvement by the Office of the Commissioner in conflict of interest issues (both in developing internal FDA

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Food and Drug Administration Advisory Committees policies and procedures and in negotiating with the DHHS Office of the Special Counsel for Ethics and the Office of Government Ethics); and more attention to preparation for and conduct and follow-up of advisory committee meetings. Various recommendations of the IOM committee address improvement of the product evaluation process and the role of advisory committees in that process. In particular, we believe that advance scheduling of committee meetings and agendas, with attendant deadlines for the sponsor and the agency, would bring greater discipline to the product evaluation process. The IOM committee recognizes that its recommendations for improved management of the advisory committee system will require additional resources. Therefore, the report provides an estimate of the incremental costs of the IOM committee's recommendations. The IOM committee regards the recommended review of advisory committee member compensation as an important management issue that deserves attention by the Commissioner and the Secretary of Health and Human Services. If a user fee system is adopted to support product evaluation, the compensation of advisory committee members should be reviewed in that context. Agency Accountability The FDA as an entity, and not its component parts, should be accountable for the effective performance of its advisory committee system. The IOM committee's recommendations lead to ways of increasing agency-wide accountability. Here, as in the recommendations above on improving management, the committee emphasizes the importance of designating a high-level official in the Office of the Commissioner who should be responsible for administrative policy and management guidance for the system. It is also important as a component of accountability to recognize that advisory committees are advisory to the FDA, and that the formal authority for decisions rests by law with the agency. It would be unnecessary to reiterate this basic distinction were it not that some agency critics regard advisory committees as independent adjudicatory bodies that should hear sponsors' views, on the one hand, and agency views, on the other, and decide in favor of one party or the other. Acknowledging this basic authority-advisory distinction should facilitate advisory committees becoming even more effective and influential than they are at present, which the IOM committee endorses. Consequently, the IOM committee's recommendations emphasize practical ways (especially in Chapter 7) to ensure the intellectual independence of advisory committees. The rationale for this emphasis is to increase

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Food and Drug Administration Advisory Committees the likelihood that advisory committees will render that impartial, expert advice that the agency and the public should expect. A CONCLUDING RECOMMENDATION In the conduct of this study, the IOM committee has discovered the multifaceted complexity of the FDA advisory committee system. It has benefited from many thoughtful letters, memoranda, and communications on aspects of this complexity. The committee has blended these views of others, both inside and outside the agency, with the knowledge and experience of its members and with the information gained in this study. As a result, the committee believes that its report, if widely disseminated, could serve to increase both internal agency accountability and external support for the advisory committee system. The IOM committee recommends that the Commissioner circulate this report widely within the FDA, to all advisory committee members, and to other interested parties. It also recommends that the report be submitted to the Secretary of Health and Human Services and to the appropriate committees of the Congress for the purpose of seeking concurrence of goals and budgetary support for the implementation of the report's recommendations. NOTES 1.   Letter from Lewis B. Sheiner, M.D., University of California, San Francisco, to Richard A. Rettig, May 4, 1992. 2.   Letter from John F. Beary, III, M.D., Pharmaceutical Manufacturers Association, to Richard A. Rettig, May 20, 1992.