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Executive Summary

The Reagan Administration's short list of candidates to become the next FDA commissioner includes two men who have direct agency experience. David Worthen, MD, currently with the Veteran's Administration, is a former member of FDA's Ophthalmic Device Panel, and Ronald Hart, PhD, is currently the director of FDA's Natl. Center for Toxicological Research. The administration is reviewing candidates for the top FDA spot in the event that current FDA Com. Young moves to a health post at HHS. Young is HHS Secty. Heckler's choice to be Asst. Secty. for Health, and his move to the dept. is reportedly awaiting only the selection of a replacement for him at FDA. The administration would like to have the HHS situation firmed up by mid-summer. Reportedly, HHS has been interviewing for the FDA commissioner spot. Worthen, 49, asst. chief medical director for academic affairs in VA's Medicine & Surgery Dept., has been an advisor to FDA's Ophthalmic Devices Div. since 1975. He became a member of the Ophthalmic Section of the Ophthalmic Device Panel in 1975 and served as chairman from 1977 to 1982. He has been a consultant to the section from 1982 to present. In addition to his VA responsibilities, Worthen is clinical professor of ophthalmology at Georgetown University in Washington and visiting professor of ophthalmology at Johns Hopkins University in Baltimore, as well as a consultant for the Howard University Medical School in Washington. Worthen is a Provo, Utah native who received his undergraduate degree from the University of Utah in 1958 and his MD from the University of Minnesota in 1961. He has been a consultant to Revlon. Hart, 43, has been director of NCTR since 1980. From 1971 to 1982, he held various positions at Ohio State University. He was an asst. professor of biophysics and radiology until 1975, and he served as director of the Radiological Research Div. from 1973 to 1982. Hart received his undergraduate degree in biology from Syracuse University in 1967, and earned an MS in physiology and a PhD in biophysics in 1971 from the University of Illinois. The HHS Assistant Secty. for Health position has been open since Edward Brandt, MD/PhD, accepted a job with the University of Maryland last fall. In February, Heckler brought Centers of Disease Control Director James Mason to Washington to fill the slot on an interim basis. At that time, Young began to be mentioned frequently as the top candidate for the permanent job. Since the first of the year, however, a number of top FDA management positions have come open, making it difficult for HHS to move Young up. Former Deputy Com. Mark Novitch, who twice during his career at FDA filled in as commissioner while a search was made for a permanent replacement, left the agency in February for a job at Upjohn. The agency has not had a deputy commissioner since Novitch left, but reportedly John Norris, a long time associate of Young's, is the top candidate for that position. Norris has been a consultant to FDA since Young took over, and has played a significant role in the drafting of Young's "action plan" for the agency. The document, intended to serve as a guide for FDA policy in the future, is reportedly near release. Young's ascension to higher status at HHS and Norris' appointment would assure continuity from the last 10 months despite a new commissioner. Other more recent agency vacancies include Orphan Products Office director, which will be open when Marion Finkel, MD, leaves in July to become R&D exec director for Berlex ("The Pink Sheet" April 29, T&G-5). In addition, FDA Executive Secretariat Dan Brand and Science Coordination Office Director Allen Heim have said they intend to leave the agency soon.

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