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Executive Summary

FDA CHOICE FOR GENERICS OFFICE DIRECTOR IS GENELABS' ROGER WILLIAMS; the agency is in the process of sending the recommendation to HHS Secretary Sullivan. CDER Deputy Director Gerald Meyer announced the agency's decision at a March 15 Food and Drug Law Institute meeting on advisory committees and FDA. In his new position at FDA, Williams will replace Bruce Burlington, who has been serving as acting director since the office was created. A physician, Williams joined Genelabs in September as the company's medical director and has been overseeing the progress of clinical trials of Genelabs' GLQ223 antiviral compound for AIDS. Prior to that, Williams was director of the University of California-San Francisco School of Pharmacy Drug Studies Unit. In that position, he had been working on Bolar's new bioequivalence studies for its generic version of Dyazide (triamterene/hydrochlorothiazide). Williams also performed the original biostudies for Mylan's Maxzide. Reportedly, when Williams was interviewed in November for the position, CDER Director Peck, MD, favored him as the top candidate ("The Pink Sheet" Nov. 27, "In Brief"). However, his prior involvement in biostudies for generic firms was an apparent hurdle to his nomination. Noting that "the person that we are in the process of appointing for the office of generic drugs is someone who is currently working for a firm and has in the past been heavily involved in the testing of products for a variety of firms," Meyer indicated that some FDA topsiders may have had reservations about Williams' nomination because "we sort of have a view that people from industry will be totally inappropriate."

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