Former FDA counsel: Off-label marketing ban in jeopardy

11/3/2011 | Wall Street Journal, The

Drugmakers have filed a friends-of-the-court brief asserting that marketing drugs for unapproved uses is protected free speech. FDA rules prohibiting off-label marketing are meant to protect patients, says Thomas W. Abrams, director of the FDA's Division of Drug Marketing, Advertising and Communications. Former FDA chief counsel Richard Cooper said a Supreme Court ruling in June on pharmacy records could put the FDA's ban on off-label marketing "in some jeopardy."

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