Case Summary and Outcome

U.S.-based pharmaceutical company Amarin Pharma manufactured a triglyceride-lowering drug, which was later approved by the U.S. Food and Drug Administration (FDA) for one particular use. The company then sought to promote the non-approved use of the drug. The promotional statements to be delivered to doctors were largely based on the FDA’s own study of the drug’s off-label use.

Upon learning about the promotion, the FDA threatened the company to bring misbranding charges under 21 U.S.C. § 331(a), which prohibits introduction of any adulterated or misbranded food or drug in to interstate commerce. The U.S. District Court of the Southern District of New York sided with company and granted its motion for preliminary injunction. It held that the scope of First Amendment protection extends to pharmaceuticals’ promotional speech and that the FDA may not bring an action solely based on their truthful and non-misleading speech to promote the off-label use of their drugs.

Facts

Amarin Pharma manufactured a triglyceride-lowering drug called “Vascepa.” In July 2012, FDA approved the drug for the particular use of treating adult patients with triglyceride level above 500 mg. Doctors, however, had widely and lawfully prescribed the drug for much higher triglyceride levels. The company later sought to market and promote the second use through making truthful statements to doctors. The promotion, in fact, was after a successful clinical trial of administering the drug to patients with persistent high or severe level of triglyceride. But an advisory committee of FDA concluded that there still remained “substantial uncertainty” as to whether the second use of the drug would significantly reduce the risk for cardiovascular events in such patients. The agency then refused to allow Amarin to include the results of the clinical trial in the drug’s label.

In light of FDA’s threat to bring a misbranding action under 21 U.S.C. § 331(a), the company sought a preliminary injunction from federal court, alleging its truthful and non-misleading statements about the non-approved use of the drug was protected under the First Amendment right to free speech.

Decision Overview

As amended in 1962, Federal Food, Drug and Cosmetic Act (FDCA) provides: “No person shall introduce or deliver for introduction into interstate commerce any new drug,” without the FDA’s approval of a “new drug application,” which must demonstrate the drug’s safety and efficacy through a series of pre-clinical and clinical trials.¹ Violating this regulation can result in criminal liability of “misbranding” under 21 U.S.C. § 331(a), which prohibits “[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.”

The pharmaceutical company raised two main arguments in seeking an injunctive relief: (1) the FDA’s threat to bring a misbranding action against its truthful statements would infringe its First Amendment right to free speech; and (2) under the federal appeals court’s decision in United States v. Caronia,² FDA cannot assert such action based solely on truthful and non-misleading statements concerning the drug’s non-approved use.

The Court first addressed the scope of First Amendment protection of a manufacturer’s truthful and non-misleading promotional statements under Caronia case. There, the Second U.S. Court of Appeals ruled that the FDA’s misbranding prosecution solely based on a truthful promotional statement about an off-label drug is inconsistent with the First Amendment. In reaching that conclusion, the appeals court applied the four-prong test of Central Hudson v. Public Service Commission of New York to assess the constitutionality of a restriction on commercial speech. It first held that the promotion of off-label drug use “is not in and of itself false or misleading;³ therefore, it satisfies the first requirement of “lawful activity.” Concerning the second prong, the court found that the FDA’s asserted interests of preserving integrity and effectiveness of its approval process are “substantial.” As to the third prong, however, it did not find that the FDA’s measure of prohibiting truthful off-label promotion “does not directly advance the asserted government interests because off-label use of approved drugs is lawful.”⁴ Lastly, the court noted that such prohibition was not narrowly drawn to further the FDA’s interests.

In light of that analysis, the Court here made it clear that if Amarin’s promotional speech at issue “is found truthful and non-misleading, under Caronia, it may not serve as the basis for a misbranding action.”⁵ Accordingly, it first examined the veracity of the statements sought by the company to disclose to doctors concerning the non-approved use of Vascepa. Amarin initially wanted to publish a study and a number of peer-reviewed scientific publications that tested the effectiveness of Vascepa on patients with high triglycerides. And in fact, the FDA had approved the study in writing and had cautioned the company to not include misleading language when publishing the peer-reviewed publications. These facts combined with the company’s modified disclosures led the Court to conclude that the promotional statements were truthful and non-misleading and therefore, the FDA was barred from brining an action based on the statements alone.

Accordingly, the Court granted Amarin’s application for preliminary relief.

1. Amarin Pharma, Inc. v. U.S. Food & Drug Admin., 119 F.Supp.3d 196, 200 (S.D.N.Y. 2015). ↩

2. 703 F.3d 149 (2d Cir.2012). ↩

3. Caronia, at p. 165-66. ↩

4. Id. at p. 166. ↩

5. Amarin Pharma, at p. 228. ↩