It ’s a Good Time to False Claims Act-Proof Your Marketing Practices

Conclusion The New Year is an excellent time to review your company’s marketing and sales practices in light of lessons learned from recent enforcement activity in the industry and to set a plan to review them throughout the year.   References 1. In 2012, the Second Circuit overturned a pharmaceutical sales representative’s criminal conviction under the Food, Drug & Cosmetic Act (FDCA) for promoting off-label use of a drug on First Amendment grounds. United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). Several years later a district court in the Second Circuit rejected the Food and Drug Administration’s (FDA’s) effort to limit Caronia to its facts and stated that the “truthful and non-misleading speech promoting the off-label use of an FDA-approved drug . . . cannot be the act upon which an action for misbranding is based.” See Amarin Pharma Inc. v. FDA, 119 F. Supp. 3d 196, 228 (S.D.N.Y. 2015). Then, in 2016, the Second Circuit extended its skepticism beyond criminal cases under the FDCA to an FCA action. See United States ex rel. Polansky v. Pfizer, 822 F.3d 613, 619-20 (2d Cir. 2016) (holding that the relator’s allegations did not actually amount to promotion for an off-label use but also expressing skepticism that such promotion could cause implied false certification that the drug was prescribed for an on-label use). ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news