sponsor employees, observers from competitor firms, the national and trade press, including cable and network television, and investment advisors.

The importance and visibility of FDA advisory committees make this study a timely effort. The Institute of Medicine (IOM) committee that conducted it hopes that its analyses and recommendations will be useful to the agency and to the public in helping the FDA fulfill its responsibilities to the American people.

ORIGINS OF THE STUDY

The study originated in remarks made by Dr. David A. Kessler, the Commissioner of Food and Drugs, at a meeting of the IOM's Forum on Drug Development in March 1991. Before his appointment as Commissioner in late 1990, Dr. Kessler had chaired the Subcommittee on Drugs and Biologics of the Department of Health and Human Services (DHHS) Advisory Committee on the Food and Drug Administration (known as the Edwards Committee, after its chairman, former Commissioner Dr. Charles E. Edwards). In that capacity, Dr. Kessler had heard testimony that challenged the credibility of the FDA's advisory committee system, and, to the Forum members, he expressed the desire to make more effective use of these committees.

The resulting interaction between the IOM and the FDA led to this study. That interaction began when the FDA requested that the IOM examine the optimal use of FDA advisory committees in the evaluation of drugs, biologics, and medical devices. The agency also asked the IOM to consider their use in relation to agency management and agency accountability.

In response, the IOM appointed a committee to conduct the study. Its members brought expertise in medical research; development of drugs, biologics, and medical devices; design and conduct of clinical trials; medicine, surgery, and nursing; regulation of drugs, biologics, devices, consumer products, and health care services; administration of medical research, health care financing, and the delivery of health care services; and health and science policy research. Three members of the IOM committee currently serve on FDA advisory committees, two others have served in the past, and three were previously involved as FDA officials in the design of the current system.

In the early months of the study, two meetings were held between the committee chair, Dr. Laurence E. Earley, and the Commissioner, the second involving the acting president of the IOM and senior IOM staff. These meetings were held to clarify certain questions about the scope and purpose of the study. Then, when the study committee convened for its first meeting



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