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FDA COMMISSIONER YOUNG: ROCHESTER DEAN WITH BIOTECHNOLOGY BACKGROUND HAS WORKED WITH MILES AS CONSULTANT FOR 12 YEARS; NIH CMTE. EXPERIENCE

Executive Summary

FDA Commissioner-designate Frank Young, MD/PhD, is the first dean of a major medical school to assume the top agency spot since Alexander Schmidt, MD, became commissioner in 1973. Young comes to the agency from a top administrative position at the University of Rochester School of Medicine and Dentistry. As VP-health affairs and dean, Young, 52, has more high level administrative experience than his immediate predecessors at FDA. The three most recent commissioners -- Hayes, Goyan, and Kennedy -- all were involved in institutional administration at the departmental level. Young will assume the commissioner post on July 15. However, the commissioner-designate wasted no time in presenting himself to FDA. Young paid an informal visit to the agency's Rockville, Md., headquarters on May 10 -- one day after HHS announced his selection as the successor to former Com. Hayes. The dean assumes the commissioner post at FDA after a 10 month interregnum following the resignation of Com. Hayes in September 1983. During that time, Mark Novitch, MD, has stepped into the breach as acting commissioner, representing the agency in the recent E-Ferol and pacemaker Hill hearings. As recently as February, Novitch had been considered one of three candidates still in the running for the post. Novitch provided topside continuity at the agency when Hayes took over a depleted staff in 1981; the acting commissioner could again be an important top aide to Young. However, Novitch is presumably a hot prospect for the private sector based on his long experience with FDA and HHS. The new commissioner, who is officially on an indefinite leave of absence from Rochester, will take over the agency less than four months before the November presidential elections. The new commissioner should help keep FDA out of the news as a liability to the Reagan Administration until the election. As a new appointee, Young is less vulnerable to attack on previous agency actions than Novitch has been in recent weeks. Young did not come to FDA through the traditional network of FDA special interests. Although the comes from Rochester, which is well-known in the drug industry for its Center for the Study of Drug Development, Young apparently was not closely aligned with that group. When asked about Young's appointment, Louis Lasagna, MD, of the Rochester center declined comment. While Young is not a familiar figure to top execs in most of the U.S. drug companies, he has had a long-standing consulting relationship with one firm, Miles Labs. Miles Director of Microbiology Research Gary Wilson, PhD, who collaborated with Young at Rochester in the mid-seventies on a number of published papers, said that Young has consulted on work in the areas of infectious diseases, including work on Nisseria gonorrhoeae at Ames, and blood factor VIII. Recognizing the sensitivity of the industry-university joint research issue, one of Young's most recent speeches was on corporate-sponsored university research in biotechnology last year. Young, who has authored or co-authored over 90 published scientific papers, follows a tradition set by recent FDA Commissioners Hayes and Kennedy by bringing to the agency a strong research background. Described by FDAers as having a scholarly academic appearance, Young has served as chairman of the dept. of microbiology and professor of radiation biology, pathology, microbiology, and biophysics at Rochester from 1970 until accepting the dean position in 1979. As a researcher, Young's work has involved the study of infectious diseases, including sexually transmitted diseases, coagulation proteins such as blood factor VIII, the role of surface components in passing on information, and rDNA and gene slicing techniques. Much of Young's work has been with five microorganisms: B. subtilis, Staphylococcus aureas, E. Coli, B. fragilis, and Neisseria gonorrhoeae. Young notes in his curriculum vitae that the emphasis of his research is "given to the transfer of basic molecular technology to clinical microbiology including anaerobic organisms." A small sample of recently published papers that Young has co-authored include: "Characterization of a chimeric beta-lactamase plasmid of Neisseria gonorrhoeae which can function in E. coli" published in the W. German publication MGG last year; "Genetic engineering of bacilli" in the Philosophical Transactions of the Royal Society of London in 1983; and "Purification and characterization of a highly purified human factor VIII consisting of a single type of polypeptide chain" in the Proceedings of the Natl. Academy of Science in 1982. Young Testified At Sen. Stevenson's And Rep. Rogers' 1977 Hearings On Regulation Of rDNA Research Young has played an active public role in a broad range of health-related policy issues. Young served on the Natl. Institutes of Health (NIH) rDNA Advisory Cmte. (RAC) from January 1979 to June 1980. During Young's term on RAC, the cmte. was faced with questions regarding purity test procedures, data analysis and plant and equipment inspections for the nascent biotechnology industry. In 1975, the new commissioner attended the Asilomar, Calif., conference, at which a group of top experts in the then-embryonic field of genetic engineering met as a group for the first time to discuss the ethical and public safety implications of their work. Young also brings to FDA prior experience with Hill hearings. In 1977, he testified at both Senator Stevenson's and Rep. Rogers' hearings on the regulation of rDNA research. One of Young's colleagues described his testimony as a "rational" approach to the regulation of rDNA technologies. Several scientists that had worked with Young in the past expressed surprise that he would accept the post of FDA commissioner because of his prominence as a microbiologist and the stature of his current post at Rochester. One former colleague of Young's who had worked closely with him for nearly 10 years at Rochester suggested that Young's interest in community service is what has prompted him to accept first the post of chairman of the microbiology dept. at Rochester, then the dean's position, and now the commissioner title at FDA. NIH advisory cmtes. have apparently become a kind of spawning ground for health agency leadership. Like Young, who has served on NIH's RAC as well as directed several NIH training programs, the new director of the Centers for Disease Control, James Mason, was a member of NIH's rDNA Advisory Cmte. during an overlapping term (1979-1983) with Young. FRANK E. YOUNG, MD/PhD Born: Sept. 1, 1931 (Mineola, NY) Career History Scientific Societies -- American Academy of Microbiology, Fellow Assn. of Medical School Microbiology Chairmen American Society of Biological Chemists American Assn. of Pathologist American Assn. for the Advancement of Science Infectious Diseases Society of America Subcmte. on the Genus Bacillus, Internatl. Cmte. on Systematic Bacteriology American Veneral Disease Assn. American Society for Microbiology The Genetics Society of America Service to Scientific Societies -- American Society of Microbiology -- Officer, General Division: Secty., 1967-1968; Vice Chairman, 1968-1969; Chairman, 1969-1970 Annual Program Cmte., 1970 Public Affairs Cmte., 1973-1979 Search Cmte. for Executive Director, 1974-1975 Chairman, Annual Meeting Program Cmte. for American Academy of Microbiology, 1974-1979 Director, American Society for Microbiology Foundation Program Cmte. U.S.-Japan Intersociety Microbiology Congress Ad Hoc Cmte. for Review of NIH Recombinant DNA Guidelines Member, Working Cmte. on Training for Recombinant DNA Research Assn. of Medical School Microbiology Chairmen Trustee; Delegate to Council of Academic Socoeties, Assn. of American Medical Colleges American Assn. of Medical Colleges Member, Administrative Board of the Council of Academic Societies Member, Council of Deans American Academy of Microbiology Member, Board of Governors Institute of Medicine Member, Program Cmte., 1981-1984 Editorial Boards -- Reviews in Infectious Disease, 1984-1979, editorial board Journal of Applied Biochemistry, 1983-1978, editorial board Gene, 1983-1976, editor Journal of Bacteriology, 1967-1973, editorial board Study Sections -- Natl. Institute of General Medical Sciences, Microbiology Training Cmte., 1972-1973 Bacteriology & Mycology Study Section, Natl. Institutes of Health, 1975-1979 Scientific Advisory Cmte. for Virology & Cell Biology, American Cancer Society, 1974-1978 Recombinant DNA Advisory Cmte., Natl. Institutes of Health, 1979-80 Chairman, Microbial Genetics Study Section, Natl. Institutes of Health, 1981-82 Industry -- Miles Laboratories, Inc., 1972-1984 Government -- Ad Hoc Consultant to World Health Organization in the Middle East: Mercury Poisoning Outbreak in Iraq, 1972 Education Union College, Schenectady, NY, 1949-1952 University of the State of New York, Upstate Medical Center, Syracuse, NY, 1956, MD Western Reserve University, Cleveland, Ohio, 1962, PhDPicture, no caption
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