Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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4 Recurring Issues
4 Recurring Issues
Pages 100-115
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From page 100... ...
MAJOR PRIOR REPORTS The history of the FDA is a history of reports about the FDA, as Hutt has noted.) In this section, we review several reports that have dealt with FDA advisory committees, usually in the context of reform of the drug approval process: the Fountain Committee report of 1976, the Dorsen Committee report of 1977, the McMahon Commission report of 1982, and the Lasagna Committee report of 1990.
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From page 101... ...
The report emphasized improved management and compliance with the act FDA staff and advisory committee members should adhere to its standards, and Congress should monitor the agency to prevent inadequate fiscal and management oversight of committees. It recommended that the FDA remedy a perceived lack of balance in the composition of advisory committees, that it cease to close meetings improperly, that meetings not be held in places that discouraged public attendance, that complete minutes of meetings be kept, and that verbatim transcripts not be destroyed prematurely.
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From page 102... ...
The Fountain Committee report reveals congressional suspicion about the FDA's use of advisory committees and a suspicion that expert committees were being used to reinforce closed decision-making processes that favored industry views. Hence, its recommendation that the FDA strengthen its own professional staff and avoid becoming overly dependent on outside committees.
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From page 103... ...
Regarding advisory committee members, the panel recommended that the FDA should issue written guidelines for selecting members; DHEW should abolish its policy barring concurrent membership on more than one departmental committee; should establish a "committee on committees to recommend nomination procedures; should rescind existing regulations concerning consumer representation and provide for voting public interest members on all standing committees. On financial conflict of interest, the Dorsen committee recommended that rules and procedures should be strict enough to guarantee the integrity of advisory committees but flexible enough to allow the FDA lo attract and retain qualified members; the agency should use specific rules to disqualify members with serious conflicts but apply graduated restrictions to different degrees of conflict; all committee meetings should be public, all significant potential conflicts of interest should be fully disclosed; committees should be restricted to advising on narrow scientific questions rather than broad regulatory matters; and efforts should be increased to kind qualified candidates with fewer potential conflicts.
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From page 104... ...
The panel report recommended that the handbook under preparation for orienting advisory committee members should include the relevant FDA statutes, the regulations for new drug approval (including the standards of safety and effectiveness) and for advisory committees, a description of the matters FDA will refer to committees, and a statement of how FDA hopes to use committee members as reviewers of INDs and NDAs.
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From page 105... ...
The McMahon Commission proposed the following reforms: outside review boards should be used in the approval process; new indications for approved drugs should be completely exempt from IND requirements; a streamlined approval process for generic drugs should be established; and manufacturers should no longer be required to send raw data to the FDA The report was optimistic about speeding the drug approval process, although a minority report commented that it failed to recognize the substantial progress FDA had made in this regard. Among its recommendations, the commission called for greater use of outside experts in the approval process: review procedures should be revised "to afford a more significant roles to experts from the academic and government biomedical research communities, and "due weight" should be given to the judgment of clinical investigators as to whether the standard of effectiveness had been met.
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From page 106... ...
The Lasagna Committee report noted a potential for increased use of advisory committees in the early stages of drug development; in evaluating INDs and NDAs, in setting priorities among drugs; in mediating between the FDA and industry, and in overseeing FDA implementation of committee recommendations. Finally, "to foster close relationships between the government agencies involved with AIDS and cancer drugs, the National
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From page 107... ...
It cited potential conflicts of interest as a specific reason for the delays and difficulties in appointing and convening advisory committees and as a barrier to the use of "many highly qualified and respected advisors." It advocated prior disclosure of potential conflicts as preferable to premature disqualification when a conflict is anticipated and urged the agency to draw on the Augustine Commission report on the National Aeronautics and Space Administration of March 1991 and the FDA Revitalization Act to reduce the impediments introduced by the current process for managing conflict of interest (pp.
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From page 108... ...
In addition, the House Committee on Agriculture, Subcommittee on Domestic Marketing, Consumer Relations, and Nutrition; the House Committee on Government Operations, Subcommittee on Human Resources and Intergovernmental Relations; the House Committee on Science and Technology, Subcommittee on Oversight; the Senate Committee on Governmental Affairs; the Senate Committee on Agriculture, Nutrition and The FDA began as the Bureau of Chemistry of the U.S. Department of Agriculture.
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From page 109... ...
Examples include the following congressional hearings held during the 101st and 102nd Congresses (from 1989 to the present) : the generic drug scandal involved 10 hearings on 19 separate days; the amendments to the Orphan Drug Act were the subject of 2 separate hearings; artificial heart valves were considered in 2 separate hearings; and the use of plentopheresis in the treatment of scleroderma was the subject of one hearing.
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From page 110... ...
Indicative of investment community interest in FDA advisory committees was the stock market's response to the advisory committee that dealt with products made by Coma and Centocor in September 1991, and which recommended approval of the latter Brm's antiseptic biologic, and the later response to the FDA's decision in May 1992 to fail to act on this recommendation. Heightened interest in the financial community recently prompted the FDA to commission a study by Kutak Rock & Campbell, a Washington, D.C., law firm, examining the treatment of financially sensitive information by the agency.
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From page 111... ...
Historically, it noted, the FDA's final decisions on approving or disapproving a drug usually agree with the prior recommendations of advisory committees. As a result, the financial community pays great attention to the discussion and final recommendations at an advisory committee meeting.
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From page 112... ...
analysts regard the mere scheduling of an advisory committee meeting for a product as an indication that FDA will reach a decision about a product within a relatively short time.~° Given the intense interest of the financial community and the effect the advance public release of questions prepared for the advisory committee might have on trading in the securities markets, the report basically concurred with current FDA practice of publicly releasing such questions on the morning of a committee meeting. Advisory committee members, as special government employees, the report noted, are subject to federal conflict of interest statutes.
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From page 113... ...
2. A wide consensus exists that the primary purpose of the FDA's technical advisory committees is to bring independent scientific expertise to bear on agency decisions.
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From page 114... ...
Consequently, any significant changes in how the agency functions require some working consensus that includes the agency, its leadership, and itS large cadre of professionals; the Congress; the Executive Branch, from the White House to the Secretary of Health and Human Services and the other agencies of the Public Health Services; the regulated industries pharmaceuticals, biotechnology, and medical devices; the academic medical science community; and organized groups representing the consumers, voluntary health organizations, and the public. The following four chapters examine analytically many of the issues that have concerned the designers, managers, and users of the advisory committee system over time.
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From page 115... ...
3. Stockman, Paul K, Applicability of the Federal Advisory Committee Act to Alternative Sources of Scientific Input, report to the IOM FDA advisory committee study (July 31, 19923.
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