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.
The judges in Caronia relied heavily upon the Supreme Court case of Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (June 23, 2011), which held that a Vermont statute prohibiting pharmaceutical companies from engaging in truthful marketing activities offended the First Amendment. While some commentators opined that Caronia was the death knell of prosecutions for off-label use, such a conclusion is misplaced. The Second Circuit did not strike down any portion of the FDCA in Caronia, nor did it limit the government’s authority to prosecute individuals or entities under the FDCA for off-label marketing that is allegedly false or misleading.
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