FDA abandons off-label marketing protection ruling

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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.

FDA rules prohibit health products makers from marketing possible uses of medical devices or drugs until the claims have been reviewed and approved by the FDA, even in if those uses have been demonstrated in clinical trials or are approved outside the U.S.

The New York Appellate court ruled in a split 2-1 decision that Caronia couldn’t be punished for his off-label marketing because that would violate his right to free speech.

"The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug," the court majority wrote.

The FDA had argued that it wasn’t prosecuting Caronia’s speech, but using his speech as evidence that he had engaged in illegal marketing of Xyrem, promoting it for use in treating chronic fatigue and drowsiness.

Dissenting Judge Debra Ann Livingston agreed with the FDA, telling reporters that "the First Amendment has never prohibited the government from using speech as evidence of motive or intent."

The FDA could have asked the same court to rehear the case or could have appealed the decision to the Supreme Court, but officials told the Wall Street Journal that the federal watchdog agency won’t pursue either option.

The agency "does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act," the FDA said in a statement.

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