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Executive Summary

CANCER/AIDS DRUG APPROVAL PROCESS TO BE REVIEWED by committee comprised of representatives from industry and academia. Established by the President's Cancer Panel, the committee will hold its first meeting Jan. 4 at NIH. Representatives from the FDA, the National Institute of Allergy & Infectious Diseases and the National Cancer Institute will give presentations at the meeting. The committee will lay out its plans and discuss future agendas. Additional meetings have already been planned for Feb. 1, March 15, and May 2. The nine-member committee consists of prominent representatives from the pharmaceutical industry and academia. Louis Lasagna, MD, Tufts University, is the chairman. The other members include Gertrude Elion, DSc, Burroughs Wellcome, who recently won the Pulitzer Prize for medicine; Theodore Cooper, MD/PhD, chairman and CEO of Upjohn; Emil Frei, III, MD, Director and Physician in Chief of the Dana Farber Cancer Institute; Samuel Hellman, MD, University of Chicago; Thomas Merigan, Jr., MD, Stanford University Medical Center; Henry Pitot, MD/PhD, University of Wisconson; Charles Leighton, MD, Merck Sharp and Dohme; and attorney Peter Hutt, of the Washington, D.C. firm Covington & Burling. The National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS was formed in response to a request from Vice President Bush. In a June letter to Armand Hammer, chairman of the President's Cancer Panel, Bush suggested that the panel undertake a "systematic study of drug regulation as it affects progress in developing and making available therapies for cancer and for AIDS, and make recommendations for improvements." Bush said the study could suggest changes to accelerate clinical trials, improve access of cancer patients to treatment, and facilitate the transfer of new therapies to clinical practice. He also suggested that the panel consider: (1) whether approval criteria for investigational new drugs and new drug applications for cancer or AIDS drugs should be modified; (2) what the appropriate endpoints should be for assessing drug efficacy; (3) what degree of flexibility clinical investigators should have in modifying approved studies, and to what degree protocol modifications should require new approvals. In addition, Bush asked the panel to consider how the roles of institutions affected by the drug approval process (FDA, NCI, and private institutions) should be modified to improve the process and whether the activities of commercial organizations conducting research could be better organized to "enhance. . . the research endeavor." FDA's approval criteria for cancer drugs has been a point of contention between the agency and NCI. NCI has criticized FDA for using too stringent efficacy requirements, such as survival data, in its review of cancer drugs. FDA told NCI at a meeting in June that the agency may base approval of oncological drugs on commplete response rates, which would be determined on a tumor by tumor basis ("The Pink Sheet" June 13, p. 13).

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