Off-Label Promotion After Caronia: Proceed with Caution -
The United States Food and Drug Administration (“FDA”) has long taken the view that promoting drugs for non–FDA-approved uses—otherwise known as off-label marketing—can be proof of misbranding, a criminal offense. False or misleading advertising of a drug is by definition a form of misbranding under the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 352(q)(1). Truthful, non-misleading offlabel promotion can also be proof of misbranding, the FDA has argued, if it demonstrates that a drug is being sold for an unapproved intended use – another form of statutory misbranding. 21 U.S.C. § 352(f) (1); 21 C.F.R. §§ 201.5. (Because the law concerning off-label marketing is virtually the same for drugs and devices we use those words interchangeably in this article.)
Recent legal developments have called into question the FDA’s long-standing position that truthful, non-misleading off-label promotion can be proof of misbranding. In 2012, the Second Circuit construed the misbranding statute not to criminalize truthful, non-misleading off-label speech “because such a construction … would run afoul of the First Amendment.” United States v. Caronia, 703 F.3d 149, 162 (2d Cir. 2012). The Justice Department did not petition for rehearing or a writ of certiorari, perhaps in the hope that future courts would read Caronia narrowly. Those hopes seemed dashed when, just three years later, a New York district court judge held that the government could not treat truthful, nonmisleading off-label promotion as “the act upon which an action for misbranding is based.” Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196, 226 (S.D.N.Y. 2015). The government did not appeal.
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