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Executive Summary

FDA's James Bilstad, MD, will head a second office of drug review under FDA's reorganization of drug and biological review and regulatory functions. Bilstad's group initially will have responsibility for the Anti-Infective Drug Products and the Metabolism & Endocrine Drug Products Divisions. Bilstad, formerly deputy director for medical affairs at the Office of Biologics Research & Review, is moving over to the new Center for Drug Evaluation and Research along with the two drug divisions. In his new position, Bilstad will report to center for drugs Director Carl Peck, MD, and will assume a position on the same level as Office of Drug Review Director Robert Temple, MD. [EDITORS' NOTE: The Oct. 26 issue of "The Pink Sheet" incorrectly reported that Bilstad would head an intact Office of Biologics Research and Review and report to new center for biologics Director Paul Parkman, MD.] At an Oct. 20 press briefing, Commissioner Young noted that as FDA's reorganization evolves other reviewing divisions may be created and that responsibilities for divisions may be transferred to different offices. Examples of this kind of institutional mitosis are FDA's creation of the Gastrointestinal & Coagulation Drug Products Division out of the Cardio-Renal Drug Products Division. The spin-off of the new group out of the Cardio-Renal Division occurred prior to major reorganization, but it probably foreshadows the type of changes that FDA is contemplating to breakup areas with extraordinary application workloads or overly broad therapeutic areas. Similarly in the biologics area, the agency has formed a Division of Cytokine Biology out of several divisions in the Office of Biological Research. A key strategic move in the restructuring plan was the severing of the Office of Biologics Research & Review into two separate units -- the Office of Biological Product Review, under Donald Burlington, MD, and the Office of Biological Research. Division of Bacterial Products Director Carolyn Hardegree, MD, is understood to be under consideration as director for the new Office of Biological Research. The Office of Drug Research & Review, headed by Robert Temple, MD, has also been slightly reconfigured. In addition to adding a separate office of drug review under Bilstad, two divisions previously under Temple -- the Drug Analysis Center and the Drug Biology Division -- are being moved to a newly formed Office of Research & Training. A director for the new research and training office has yet to be appointed. The formation of this new unit is consistent with Peck's public objective of keeping reviewers up to date on changing science and technology. The Office of Compliance, like the Office of Management, is being split into separate offices in biologicals and drugs. Thomas Bozzo, from the Sterile Drugs and Biologics Branch of the Manufacturing and Product Quality Division, is understood to be in line to head the Office of Compliance in the new Center for Biologics Evaluation and Research. Daniel Michels will be director of the Office of Compliance in the center for drugs. Elaine Esber, MD, formerly director of the Office of Biologics Research & Review, is slated to be associate director for research and regulatory coordination in the center for biologics. She will coordinate the office of biological products and the office of biological research. Gerald Quinnan, MD, former director of the Virology Division, has been picked to be Parkman's deputy director.(ITEM 190)Charts 1 and 2, FDA's DESCRIPTION OF NEW ORGANIZATION FOR DRUGS & BIOLOGICS, The two boxes below are reproductions of preliminary organization charts prepared by management officials in the Center for Drug Evaluation & Research and the Center for Biologics Evaluation & Research. The names of the personnel filling the top management slots have been provided to "The Pink Sheet" in interviews with FDA management officials. An with all government personnel matters, the charts are subject to further change. Chart omitted.

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