In the Courts

On Dec. 3, 2012, the U.S. Court of Appeals for the Second Circuit, in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), vacated the criminal conviction of former pharmaceutical sales representative Alfred Caronia, whose conviction stemmed from off-label promotion of a Food and Drug Administration (FDA)-approved drug. Notably, the court based its decision on First Amendment grounds, and held that the government cannot prosecute pharmaceutical manufacturers and their representatives “for speech promoting the lawful, off-label use of an FDA-approved drug.” Id. at 169.

Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA must approve of a drug's specific uses prior to distribution to the general public. 21 U.S.C. ' 355(a). Although doctors may freely prescribe a drug for purposes not approved by the FDA, the FDCA expressly prohibits the “introduction or delivery for introduction into interstate commerce of any ' drug ' that is ' misbranded.” 21 U.S.C. ' 331(a). A drug is “misbranded” when labeling fails to bear “adequate directions for use.” 21 U.S.C ' 352(f). Directions are “adequate” when a person “can use a drug safely and for the purpose for which it is intended.” 21 C.F.R. ' 201.5. Promotional statements by a pharmaceutical company or its representatives can serve as proof of a drug's intended use. Id. And if the FDA has not approved the intended use, then these promotional statements could be used as evidence of misbranding. Importantly, however, such statements do not constitute a crime in and of themselves under the FDCA and related regulations. See Caronia, 703 F.3d at 155 (citing 21 C.F.R. ' 201.5).'