FDA Official Says Off-Label Ruling Won't Limit Enforcement

Law360, Washington (January 30, 2013, 2:58 PM EST) -- A U.S. Food and Drug Administration official on Wednesday maintained that the Second Circuit's decision to overturn a pharmaceutical sales representative's misbranding conviction won't change the agency's enforcement activities, saying there's no conflict between the First Amendment and their off-label promotion standards.

Thomas W. Abrams, the director of the FDA's Office of Prescription Drug Promotion, told pharmaceutical companies and counsel that the Second Circuit's decision in U.S. v. Caronia will not affect its enforcement of the Food, Drug and Cosmetic Act, and that the opinion revolved...
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