Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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Pages 1-32
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From page 1... ...
Three members of the IOM committee currently serve on FDA advisory committees, others have seIved in the past, and several were previously involved as FDA officials in the design of the current system. In general, advisory committees are the major way by which the FDA obtains independent technical and scientific advice.
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From page 2... ...
However, the IOM committee recommends a number of administrative and procedural changes that are designed to improve the performance and usefulness of the advisory committee system. The- Roles of FDA Adwso~g Committees The IOM committee believes that the primary role of FDA technical advisory committees is and should be to provide independent expert scientific advice to the agency in its evaluation of specific drugs, biologics, or medical devices at any stage of consideration by the agency.
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From page 3... ...
the evaluation of drugs, biologics, and medical devices regarding their safer and effectiveness, including indications and contraindications for use and related issues of labeling, and (b) to broader technical issues related to product evaluation, such as specific methodologies for assessing a particular class of therapeutic agents.
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From page 4... ...
This policy limits the expertise that can be tapped for a particular committee and impedes meeting diversity objectives. The IOM committee Commends that the Department of Health and Human Services eliminate its policy prohibiting dual committee membership and that qualified candidates for FDA adwso~y committees be allowed to decide whether they wish to serve on more than one Public Health Service committee.
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From page 5... ...
The IOM committee recommends that the FDA adopt an agengy-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.
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From page 6... ...
It considered and rejected the extension to drug and biologics advisory committees of the legally-required CDRH approach of nonvoting consumer and industry representatives but chose not to recommend mofication of the law. The TOM committee believes that the concept of ~consumern~oth for consumer-nominated members and consumer representatives~should be expanded to include patients or patient-nominated individuals, whose viewpoints can be valuable in the product evaluation process.
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From page 7... ...
The TOM 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 and division directors, and executive secretaries share responsibility for recruiting qualified advisory committee members.
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From page 8... ...
For each committee meeting, the FDA reviews each committee member's interests and affiliations in relation to the agenda to determine whether a potential financial conflict or the appearance of such conflict exists. The discovery of a potential conflict disqualifies a member from participating in the particular discussion of a specific agenda item unless a waiver is granted.
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From page 9... ...
intended to facilitate the use of expert advisory committees by empowering agency heads to grant waivers from the law's basic prohibition when the need for an individual member outweighed any potential conflict. Responsibility for implementing the executive order and the new statute fell primarily on the OGE and, within DHHS, on a new unit in the Office of the General Counsel.
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From page 10... ...
Fifth, both the agencies lawyers and those from OSCE, who felt compelled to change the rules to accord with the law and executive order, dealt with waiver issues on a case-by case basis, and provided little general guidance to those administrators responsible for managing the advisory committee system. To make matters worse, all of these changes were occurring within a very short span of time.
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From page 11... ...
Yet because the interpretation of a prohibited interest is already extremely broad, and potential conflict cannot be identified before meeting agendas are set, serious pursuit of this problematic approach might disqualify valuable members and produce no gain in integnty. Moreover, the conflicts of interest that might arise over the duration of a committee membership are unpredictable at the time of appointment.
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* The TOM committee notes that if the FDA adopts the recommendation for advance scheduling of advisory committee meetings proposed below and in Chapter 7, it may be possible to increase this period of time.
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From page 13... ...
The IOM committee recommends that the FDA develop an orientation program for its advisory committee members and that this program include e~licit attention to conflict of interest in the context of a broader orientation to the public service aspects of advisory committee membership. Eighth, the FDA and OSCE, on behalf of DHHS, should seek the issuance by OGE of a government-wide general 208(b)
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From page 14... ...
Although the legal restrictions that might govern the treatment of intellectual bias on the part of advisory committee members may be quite uncertain, the matter should nevertheless be of concern to the FDN One reason for such concern is that a committee whose advice is not impartial defeats the purpose of seeking independent expert advice. A second is that committee members who were not open to persuasion by evidence would erode public confidence in a mechanism that FDA has devised to generate such confidence.
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From page 15... ...
The TOM committee recommends that the FDA develop criteria and procedures for identifying potential intellectual bias of advisory committee members and protecting the objectivity and impartiality of advisor committees. The committee recommends that the agency routinely request information about research interests and publicly stated positions on scientific issues from advisory committee members.
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From page 16... ...
The IOM committee recommends that FDA adopt a policy of annual advance scheduling of advisory committee meetings and of meeting agendas, with review cycles baring deadlines for sponsor submission of data, FI) A completion of renews, and advance distribution of materials to committee members.
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From page 17... ...
, in September 1991, clarified the range of issues that it might bring to an advisory committee: the approvability of specific drugs; general drug development; issues pertaining to marketed drugs; and the management of the new drug evaluation (NDE) program.1 Advice on the approvability of specific drugs may be sought on clinical trial design; the data supporting safety, effectiveness, overall risk-benefit, and dosing and scheduling; appropriate surrogate endpoints; other needed studies; postmarketing surveillance; indications for specific populations; and shifts of prescription drugs to over-the counter status.
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From page 18... ...
The IOM committee recommends that the FDA routinely send the general statement of the regulatory criteria governing product evaluation to each advisor committee member in advance of a meeting to assist members in framing their renew of the data. Setting the detailed agenda of an advisory committee meeting and preparing specific questions for it are primarily the responsibility of FDA staff.
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From page 19... ...
The IOM committee recommends that questions asked of advisory committees be fair and objective in tone and avoid language that might be considered biased or inflammatory. Timely Distribution of Materials A major complaint of FDA advisory committee members that has been heard for many years is that the agency often fails to distribute materials sufficiently in advance of a meeting to permit their careful review by committee members.
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From page 20... ...
The committee also believes that scheduling committee meetings and agendas in advance should facilitate compliance with this recommendation. Summaries of Materials Sent to Advisory Committees The format of materials sent to advisory committee members varies according to how much of an application the FDA decides to send.
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From page 21... ...
The IOM committee notes a discrepancy between practice in some parts of the agency and the views of the Chief Counsel, endorses the opinion of the latter, and Commends that the agency claril} the legal bases governing communication among advisory committee members. If, as expected, the Chief Counsel's opinion is adhered to as agency policy, this should be clearly communicated in writing to all ADA personnel who deal with advisory committees, to committee members themselves, and to other interested parties.
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From page 22... ...
A recent report by Kutak, Rock & Campbell, which dealt with FDA's handling of financially sensitive information, basically concurred that FDA release of the questions to the public on the morning of a committee meeting was sound practiced The FDA has before it the Kutak Rock & Campbell report and this IOM report on advisory committees; it must address the implications of where the two intersect and make any an~rounate policy determinations. -- -a Err- -r Conducting an Advisor Committee Meeting The successful conduct of an advisory committee meeting involves the conscientious efforts of the committee chair, the members, FDA officials, and the sponsors.
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From page 23... ...
The IOM committee recommends that advisory committee chairs be routinely oriented to their authorities and responsibilities in regard to the control of electronic coverage of advisory committee meetings, for the purpose of facilitating committee deliberations without compromising the publicts light to know. Voting Voting by CDER and CBER advisory committees occurs at the discretion of the committee chair or according to the tradition of the reviewing division.
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From page 24... ...
Agency Neutrality As a general proposition, the TOM committee believes that FDA staff members should conduct themselves at advisory committee meetings in ways that avoid the appearance of exerting undue influence over the committee. Agency presentations to a committee should focus on the critical evaluation of data but should not withhold or disguise expressions of agency concerns with an application.
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From page 25... ...
A systematic effort to provide follow-up would convey a strong positive message to advisory committee members that the agency attaches great value to their service. The IOM committee Commends that the FDA follow up each advisory committee meeting by routinely and immediately providing committee members with a copy of all press releases issued after a meeting; informing members by FAX at the time of approval or disapproval of any application that the committee has considered; routinely reporting the status of maffers previously considered by the committee at the beginning of each meeting; and reporting annually the disposition of committee-related maffers.
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From page 26... ...
Center directors should implement agency-wide policy for advisory committees; monitor the recruitment of members for technical expertise, source of nomination, and identification of qualified women and minority candidates; personally approve any "custom tailoring of committees to avert charges that FDA staff are seeking to influence the outcome by the selection of members known to favor a particular view, help design an orientation and training program for committee members; examine issues that arise in a particular committee that may cut across several committees; and support innovation in the use of advisory committees. Office and division directors of the product review units should also have explicit responsibilities for managing the advisory committee system.
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From page 27... ...
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 role clarification should be to ensure that advisory committees provide the independent expert advice that the agency requests and needs.
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From page 28... ...
Neither CDER nor CBER compensates committee members for homework in this way. FDA regulations also permit payment to advisory committee members at the daily rate for travel tune that involves 50 percent of an additional day beyond the meeting time and that results in the loss of some regular compensation.
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From page 29... ...
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 advisory committee 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 polic y and management guidance to the advisory committee system.
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From page 30... ...
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 and make more effective use of advisory committees. The IOM committee recognizes that its recommendations for improved management of the advisory committee system will require additional resources.
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From page 31... ...
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.
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From page 32... ...
Peck, M.D., Director, and Gerald F Measurer, Deputy Director, Center for Drug Evaluation and Research, "Advisory Committees: Policy and Practices in Selection of Agenda Items to be Considered by Center for Drug Evaluation and Research Advisory Committees," September 1991.
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