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Executive Summary

FDA's MEDICAL DEVICE REVIEW OVERHAUL WILL AFFECT DRUG REGULATION through the reassignment of two key agency staffers: Ann Witt and Robert Temple. Witt, who has been heading the agency's stepped up effort in the control of drug promotional practices, is moving on a full-time basis to an internal agency consulting group. The group was established by FDA Commissioner Kessler to advise the agency's Center for Devices & Radiological Health on legal and scientific/clinical issues related to device approval decisions. Temple will be expected to spend about 20% of his time (or roughly one day per week) working on the review of the device approval process and device evaluation decisions. Witt has quickly developed the reputation of a strong-willed activist in the drug promotion area. She has overseen a more aggressive pursuit of corrective actions for alleged violations and the development of guidelines for non-traditional forms of promotion -- such as symposia. She is being reassigned before the release of a second copy of the agency's proposed symposia guidelines. Cheryl Graham, who has been acting as Witt's deputy in the drug advertising division at FDA, is moving up to head the office. Graham's close involvement in most ongoing projects should assure continuity in the office. The establishment of a consulting group to advise CDRH indicates several aspects of Kessler's management style at FDA. The quick reaction shows Kessler's awareness of the political demands for some sign in response to Congressional and media charges of inefficiency at FDA. His choice of individuals from other sections of the agency indicates his penchant for bringing in people with whom he has worked before and putting them in positions above existing staff. In the case of Witt and Temple, the move reinforces the high regard in which they are held by Kessler. The consulting group will report to FDA Deputy Commissioner for Operations Jane Henney, MD. The FDA consulting group was announced within two weeks of Kessler's decision to replace the director of the office of device evalution, Robert Sheridan. Alan Andersen, PhD, director of the device center's office of science and technology, has assumed the ODE director post on an acting basis. The device center will be seeking a permanent replacement for Sheridan in the coming months. The search is likely to focus on candidates with medical school training.

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