The US Court of Appeals for the Second Circuit has issued an important and long-anticipated decision in United States v. Caronia, No. 09-5006-cr. 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 to the US Constitution. This precedent could have a significant impact on FDA regulations and US government enforcement moving forward. This article examines the facts of the Caronia case, the Second Circuit Caronia ruling, the rationale for the Second Circuit Caronia decision and the impact of the Second Circuit Caronia decision.

This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.