Landmark Second Circuit Decision Strikes Down Criminal Prohibition Against Truthful and Non-Misleading Off-Label Communications By Pharmaceutical Companies

On December 3, 2012, the U.S. Court of Appeals for the Second Circuit issued its long-anticipated decision in United States v. Caronia, No. 09-5006-cr.  In a 2-1 opinion authored by Judge Denny Chin, the court held that construing the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations to prohibit pharmaceutical companies from engaging in truthful and non-misleading speech regarding unapproved or "off-label" uses of Food and Drug Administration (FDA) approved drugs violates the First Amendment.  The Second Circuit applied the First Amendment analysis set forth in Sorrell v. IMS Health Inc., a case that Arnold & Porter handled at the trial and appellate stages, including the petition and merits phases in the U.S. Supreme Court. The landmark Caronia ruling calls into question the core prosecutorial theory used by the government to bring criminal enforcement actions for off-label promotion under FDA's "intended use" regulations and may also limit the ability of the government and private plaintiffs to argue that off-label promotion leads to the submission of false claims. Arnold & Porter has prepared an advisory that may be read by clicking here.