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Executive Summary

FDA CENTER FOR DRUGS AND BIOLOGICS SPLIT: MANAGEMENT RESPONSIBILITIES are beginning to firm up in the wake of the proposed separation of the center. Under the plan forwarded to HHS for review at the end of July ("The Pink Sheet" Aug. 10, T&G-4), Uniformed Services University of Health Sciences Clinical Pharmacology Division Director Carl Peck, MD, will head the Center for Drug Evaluation and Research. The current Center for Drugs and Biologics acting director, Paul Parkman, MD, will head the new Center for Biologics Evaluation and Research, which will include regulation of AIDS products. Peck is expected to come on board at FDA by mid-October. Although both the proposed split of the Center and Peck's appointment are still subject to approval by HHS, FDA is making progress in divvying up the management responsibilities. At a Sept. 15 Regulatory Affairs Professionals Society meeting, FDA Division of Management Systems and Policy Director Robert Bell noted that he would be heading the Office of Management in the new drugs center. Russell Abbott, who currently heads the Office of Management for the Center for Drugs and Biologics, will become director of the Office of Management in the new biologics/AIDS center. Bell noted that long time FDAer Gerry Meyer, the associate commissioner for management and operations, has been asked to be deputy director of the Center for Drug Evaluation and Research. Explaining the rationale behind the proposed split, Bell said: "The commissioner, some time ago, in thinking about the problems that he and the agency were facing, decided that he would split the Center for Drugs and Biologics back into a Center for Biologics and a Center for Drugs. The reasoning behind that, I believe, was that no one person, no matter how good Dr. Parkman is, can handle the pressure that is occurring today in two main areas, both of which the commissioner believes are the only two areas where he is going to be accounted for in the following couple of years -- one is AIDS, and one is the new drug approval process."

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