Cases & Deals

Washington Legal Foundation successfully challenges FDA's "off label" speech restrictions

Clients Washington Legal Foundation

On behalf of the Washington Legal Foundation, Jones Day filed an amicus brief in, and participated in oral argument before, the Second Circuit in an appeal involving the First Amendment limits to the FDA's regulatory regime for prescription drugs under the Federal Food, Drug and Cosmetic Act (the "FDCA"). In a split decision, the Second Circuit agreed with the Washington Legal Foundation's position that the criminal conviction in the case violated the First Amendment. The Court initially rejected the United States' position that it had not prosecuted the defendant for his speech, holding that "[a] pharmaceutical representative's promotion of an FDA-approved drug's off-label use is speech." The Court next held that the United States' speech ban violated the First Amendment, holding that the ban was subject to heightened scrutiny because it discriminated on the basis of content and speaker and that the ban could not survive under the commercial-speech test because it did not directly advance, and was not narrowly drawn to further, any substantial government interest. The Court "conclude[d] simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug."

United States v. Caronia, 703 F.3d 149 (2d Cir. 2012)