Second Circuit Invalidates Misbranding Conspiracy Conviction On First Amendment Grounds

In a decision with potentially important implications for the pharmaceutical industry and for government regulation of commercial speech more generally, a divided Second Circuit panel yesterday vacated the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce in violation of the Food, Drug and Cosmetics Act (FDCA) on the ground that his conviction rested solely on speech promoting an FDA-approved prescription drug for off-label uses. Because the decision in United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012), left open the possibility that speech promoting off-label uses could still be used as evidence of a drug's intended use for purposes not approved by the FDA to support a misbranding charge, the exact breadth of the decision's implications are uncertain. But, at a minimum, it establishes that truthful, non-misleading speech by sales representatives is not enough, standing alone, to support a misdemeanor misbranding prosecution in one important region of the country, and it likely paves the way for further First Amendment challenges not only to federal misbranding investigations, but also to federal regulation of other types of commercial speech.

Background

Under the FDCA, drugs must be approved by the FDA for specific uses before they can be sold in interstate commerce. 21 U.S.C. § 355(a)-(d). To obtain FDA approval, a manufacturer must demonstrate, through clinical trials, the drug's safety and effectiveness for each intended use. But once approved for any use, they may be prescribed by physicians for un-approved, or "off-label," uses as well. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350 (2001) (citing 21 U.S.C. § 396). The FDCA prohibits introducing drugs into interstate commerce that are "misbranded," which means, among other things, lacking directions for the drug's use which would enable a layperson to use the drug safely and for its intended uses. See 21 U.S.C. § 331(a); 21 C.F.R. § 201.5. In recent years, the government has gained major settlements from leading pharmaceutical companies in part based on allegations of off-label promotion.

Caronia marketed a drug that was approved by the FDA to treat two conditions in narcolepsy patients. Slip Op. at 12. According to the Second Circuit, the evidence showed that Caronia promoted the drug's use for unapproved indications and unapproved populations. Id. at 14-16. The jury convicted...