FDA abandons off-label marketing protection ruling

January 24, 2013 by MassDevice staff

Federal officials decide not to appeal a recent court decision that protected a salesman's off-label marketing activities as free speech.

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Government officials decided this week not to pursue appeal of a judge's decision to protect a salesman's off-label activities as part of his right to free speech, a ruling that may put a kink in the FDA's efforts to curtail inappropriate medical device and drug marketing.

A New York court late last year overturned a lower court's ruling against Alfred Caronia, who was convicted in 2009 for illegally marketing narcolepsy drug Xyrem for uses that weren't approved by the FDA.

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