the likelihood that advisory committees will render that impartial, expert advice that the agency and the public should expect.


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.



Letter from Lewis B. Sheiner, M.D., University of California, San Francisco, to Richard A. Rettig, May 4, 1992.


Letter from John F. Beary, III, M.D., Pharmaceutical Manufacturers Association, to Richard A. Rettig, May 20, 1992.

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