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In Major Ruling, Federal Appeals Court Limits Prosecutions for Off-Label Promotion, On Constitutional Grounds

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12.04.2012 | Legal Update

On December 3, 2012, the Second Circuit Court of Appeals ruled that the Food, Drug and Cosmetic Act cannot be interpreted to prohibit truthful, non-misleading speech about lawful unapproved uses of an FDA-approved drug, because such an interpretation of the law would violate the First Amendment. In effect, the court ruled that Congress cannot ban off-label promotion of a drug (or device) absent some other improper conduct. The Second Circuit vacated the criminal conviction of a pharmaceutical company sales representative who had been prosecuted for touting unapproved uses of Xyrem, a powerful central nervous system depressant.

In defending our health care clients, Nutter attorneys in recent years had frequently raised with prosecutors and judges the First Amendment argument that the Second Circuit accepted. While recognizing that the FDA has an important role to play in regulating drugs and devices, many of us who defend government enforcement cases believed there was something wrong about banning truthful, non-misleading speech that helped physicians prescribe drugs for their patients. The court's ruling vindicates this view, though none of us will be surprised if the government seeks further appellate review of this decision.

This legal update was prepared by the Government Investigations and White Collar Defense practice group. For more information, please contact your Nutter attorney at 617.439.2000.

This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising. 

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