News & Events

News & Events

3.12.2013

Ninth Circuit Affirms Prosecution for Off-label Marketing

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Over the past two years, courts began to recognize that at least some off-label marketing is protected lawful commercial speech under the First Amendment.  Specifically, the Second Circuit in New York in a case called United States v. Caronia held that truthful off-label marketing is a form of protected First Amendment commercial speech that cannot be prosecuted under 21 U.S.C. §333 of the Food, Drug and Cosmetic Act (“FDCA”).  The Ninth Circuit issued an opinion last week that reaffirmed the ability of federal authorities to prosecute false statements concerning off-label promotion.  In truth, despite the decision in Caronia, prosecution for off-label marketing remains a high priority for the FDA and the U.S. Department of Justice and companies are well-advised to thoroughly vet such materials before they are communicated to the public.

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