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Executive Summary

FDA OFFICE OF DRUG STANDARDS DIRECTOR RHEINSTEIN MOVING WITHIN AGENCY to the Office of Health Affairs to become director of Medicine Staff. As director of the Office of Drug Standards, Peter Rheinstein, MD/JD, was in a management position above the agency's generic drug review activities in the period between the enactment of the Waxman-Hatch ANDA/patent restoration act and the eruption of the generic drug investigations in 1989. Generic drug and bioequivalence review responsibilities were moved from under Rheinstein's purview in August 1989 and made a separate office within FDA's Center for Drug Evaluation and Research. Rheinstein also has had management responsibility for FDA's oversight of prescription drug advertising for 16 years. He commented on his role in ad regulation in an Aug. 23 memo to the staff of the Office of Drug Standards. Since 1974, Rheinstein noted, "the growth in the technology of promotion has rivaled the growth in the technology of health care." He credited the FDA Division of Drug Advertising and Labeling with keeping "pace with prescription drug advertising targeted at ever larger audiences, which now include consumers, formulary committees and purchasing managers as well as the traditional physicians and pharmacists." Rheinstein's switch may create an opportunity for reorganization within the Center for Drug Evaluation and Research. The disparate functions currently under the Office of Drug Standards (Rx ad control and OTC drug evaluation) could be parceled out to different areas within CDER. For a number of years, the OTC drug industry, for example, has been seeking more autonomy for OTC drug evaluation. Similarly, in recent years, some situations have arisen in which a lack of communication between the new drug review functions and ad reviews has led to ads being questioned by FDA after they have begun to run in journals. The most notable of those situations was the Sandoz Tavist consumer ad campaign in 1987. FDA management now has the opportunity to consider organizational changes to cut off those types of crossed wires in the future. In his new position, Rheinstein will be in a staff job reporting to the FDA commissioner through Associate Commissioner for Health Affairs Stuart Nightingale. Rheinstein will head a group of about 10 and will be responsible for FDA's liaison with professional medical societies and for FDA's activities in relation to technology assessment and reimbursement decisions. Rheinstein's predecessor in the job, Thomas Holohan, moved to head the Office of Health Technology Assessment in the HHS Agency for Health Care Policy and Research earlier this year. A frequent public speaker, Rheinstein will be an experienced representative of the agency with outside groups. Rheinstein has continued to practice medicine during his tenure at FDA and has had appointments to emergency rooms at hospitals and at nursing homes in the suburban Washington, D.C. area.

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