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Executive Summary

DRUG R&D COST STUDY GROUP AT OTA WILL BE CHAIRED BY Frederick Scherer of the Kennedy School of Government at Harvard and will include 16 members, including three former FDA officials. The ex-FDAers on the congressional Office of Technology Assessment committee are former Commissioner, and later HHS Assistant Secretary for Health, Charles Edwards (currently president of the Scripps Clinic); former FDA Chief Counsel Nancy Buc (Weil Gotshal & Manges); and former Cardio-Renal Drug Division reviewer Thomas Garvey. With a background at FDA, in industry (as an Exec VP with Becton-Dickinson) and at the Scripps Clinic and Research Foundation for over a decade, Edwards has an three-sided perspective on the cost of research debate. Four representatives from the drug industry are on the panel: Amgen Chariman George Rathmann; Lilly VP Leigh Thompson; retired Upjohn VP-R&D Jacob Stucki; and Merck finance VP Judy Lewent. Lewent is a specilist in tracking costs of R&D projects. She participated in a recent briefing for one of the congressional liaisons to the OTA committee, Sen. Kennedy's chief health staffer Stephen Keith, earlier this year ("The Pink Sheet" Sept. 11, T&G-6). * Ex-PMA President Lewis Engman has also been recruited for the advisory panel. Engman, a partner with Winston & Strawn, pushed for more academic studies on the cost of research and pharmaceutical treatment while at the Pharmaceutical Manufacturers Association from 1979-1984. As a former commissioner of the Federal Trade Commission, Engman is also versed in the issues of industry concentration. The OTA group is officially called the advisory panel on "Government Policies and Pharmaceutical Research and Development." Academia is represented by Harvard Medical School professor Jerry Avorn; Martin Neil Baily (Economics Department, University of Maryland); William Comanor (Economics Department, University of California - Santa Barbara); and Shyam Sunder (Carnegie-Mellon Graduate School of Industrial Administration). Robert Helms, former HHS official and current executive director of the American Pharmaceutical Association-affiliated American Pharmaceutical Institute, is also a panel member. The group includes one financial/securities analyst, Frederic Greenberg, previously with Goldman Sachs and now a partner at EGS Partners. The Consumer Federation of America is represented by a legislative analyst, Gene Kimmelman.

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