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Executive Summary

FDA COMMISSIONER YOUNG WILL REMAIN WITH THE AGENCY, he informed his staff at a recent meeting. The commissioner will continue his tenure at FDA after declining an offer from HHS Secty. Otis Bowen, MD, to become the department's Asst. Secty. for Health. Young's decision ends long standing speculation that he would become HHS' Asst. Secty. for Health. Young was former HHS Secty. Heckler's choice to become Asst. Secty. for Health, a position left vacant on a permanent basis since the departure in October 1984 of Edward Brandt, MD, to become Chancellor of the University of Maryland at Baltimore. Although Young was reportedly not opposed by the White House, his appointment to the HHS position got caught in the feuding between Heckler and the White House that eventually led to Heckler's resignation last fall. When he became commissioner in the summer of 1984, Young was widely perceived as a short term leader who would quickly set policy goals for the agency consistent with overall administration objectives, and then move on to HHS. However, Young has now headed FDA for over a year and a half, and he is currently involved with implementing the policy objectives contained in his "action plan" for FDA, developed in the first year of his tenure. Reportedly, Young told Bowen that FDA needs more autonomy from HHS and Office of Management & Budget oversight in order to carry out the action plan, which includes as a top priority improvements in the new drug review system. Young also met two weeks ago with OMB to expedite OMB's review of a long delayed device premarket approval regulation. Last week, that proposal was returned by OMB to FDA for technical modifications. It is to be returned to OMB for final clearance. With Young out of the running, Donald MacDonald, MD, will continue as Acting Asst. Secty. for Health, a job he has held since shortly after Bowen came to HHS. He is now the front runner to be the permanent officeholder. MacDonald reportedly has meshed well with Bowen and his top aides, including HHS Deputy Undersecretary Don Newman and Thomas Burke, the secty.'s acting chief of staff. The asst. secty.'s responsibilities at HHS primarily involve supervision of the Public Health Service, which includes FDA; the Centers for Disease Control; the Health Resources and Services Administration; the National Institutes of Health; and the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). Prior to the HHS post, MacDonald was appointed administrator of ADAMHA by President Reagan in July 1984. Before taking on the position at ADAMHA, MacDonald was a pediatrician in Clearwater, Florida, and a clinical associate professor of pediatrics at the University of South Florida. According to HHS, MacDonald is a "national leader in the parents movement against drug abuse." MacDonald has been affiliated with several substance abuse programs such as the American Council on Drug Education, National Federation of Parents for Drug-Free Youth, and Straight, an adolescent drug treatment program. MacDonald is a graduate of Williams College, Williamstown, Massachusetts, and Temple University Medical School in Philadelphia.

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