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FDA will not seek Supreme Court review in off-label promotion case

NEWS IN BRIEF — Posted Feb. 11, 2013

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The Food and Drug Administration will not fight an appeals court decision enabling pharmaceutical representatives to promote appropriate off-label uses for their medications without penalty.

The 2nd U.S. Circuit Court of Appeals in December 2012 ruled that blocking drug companies from promoting truthful statements about off-label drug uses violates the First Amendment. The decision exonerated former Orphan Medical Inc. drug representative Alfred Caronia, who was convicted of illegally marketing narcolepsy drug Xyrem (sodium oxybate) for uses that were not described in the drug’s labeling. Under the federal Food, Drug and Cosmetic Act, drugmakers are prohibited from marketing drugs for unapproved uses.

In a statement issued in January, the FDA said it had determined not to seek further review of the 2nd Circuit’s decision. The FDA does not believe that the Caronia decision will significantly affect the agency’s enforcement of the federal law’s drug misbranding provisions, the agency said. It added that the court’s decision does not strike down any provisions of the law or call into question the validity of the law’s drug approval framework.

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