Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label promotion of FDA-approved prescription drugs.” The two-judge majority based its holding primarily on last year’s Supreme Court decision in Sorrell v. IMS Health, Inc., which held that “[s]peech in aid of pharmaceutical marketing…is a form of expression protected by the Free Speech Clause of the First Amendment.”

The Caronia decision is a major blow to one of the government’s theories of criminal liability for off-label marketing – that promotion of a drug through commercial speech for a use that does not appear on the labeling approved by the Food and Drug Administration (“FDA”) for the drug is itself illegal under the FDCA. Because it may have such a major impact on the government’s strategy, we think it unlikely that Caronia will be the last word on the subject. The government may seek en banc review by the full Second Circuit or an appeal to the Supreme Court or both, especially given the dissent’s strongly-worded opinion that suggests the Caronia decision could undermine the FDCA’s entire regulatory scheme. Thus, while it remains to be seen whether Caronia is a watershed moment or a narrow departure from current law, it should embolden the pharmaceutical industry to continue to press the argument that providing factual information that is not false or misleading to physicians and patients about potential off-label uses of FDA-approved drugs should not be unlawful.

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