Court rules that convicted salesman's off-label marketing is protected as free speech

Tue, 12/04/2012 - 3:03pm
Mass Device

A New York appeals court's decision to reverse a conviction against a drug salesman accused of off-label promotion may have significant implications for the way the FDA regulates device and drug marketing.

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A New York court ruled this week that a formerly convicted salesman's off-label promotion is protected under his right to free speech, potentially tearing down certain of the FDA's abilities to regulate and penalize medical device and drug marketing.

A 3-judge panel for the 2nd Circuit Court of Appeals vacated a ruling against Alfred Caronia, who was convicted in 2009 for illegally marketing narcolepsy Xyrem for uses that weren't approved by the FDA.


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