Sklamberg moves from ORA to top spot in FDA Office of Compliance

Howard Sklamberg, who has been the FDA deputy associate commissioner for regulatory affairs in the Office of Regulatory Affairs (ORA) since July 2011, is stepping up to become director of Center for Drug Evaluation and Research's Office of Compliance. He replaces Lisa Bernstein, who has been acting director since August 2011. Bernstein will return to her former role as deputy director. The switch will occur Jan. 14, according to an FDA memo that appears in Pharma Manufacturing. The memo says Bernstein will continue to work on the recent meningitis outbreak tied to steroid drugs made at New England Compounding Center that has led to 510 infections and 36 deaths. Sklamberg also has been involved in that probe, the memo points out. A former federal prosecutor with a degree from Harvard Law, Sklamberg was involved in issues related to counterfeit drugs, drug shortages and the inspections of Johnson & Johnson's ($JNJ) McNeil Consumer Healthcare, which last year signed a consent decree with the FDA after it had to recall and destroy tens of millions of consumer products for a laundry list of manufacturing problems. Letter | More

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