Dublin, Ireland based Amarin Pharma, Inc., (Amarin) and the FDA have entered into a proposed settlement in the First Amendment litigation involving Amarin’s off-label promotion of its approved cardiovascular drug Vascepa® (icosapent ethyl). Under the terms of the proposed settlement, which must be approved by the U.S. District Court for the Southern District of New York, the FDA and the U.S. government have agreed to be bound by an August 7, 2015, judicial declaration that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa and that certain statements and disclosures that Amarin proposed to make to health care professionals are truthful and non-misleading.
The specific statements Amarin sought to make about Vascepa were derived largely from an FDA-approved study of Vascepa’s off-label use and FDA writings on that subject. Amarin contended, and the FDA largely conceded, that the statements were truthful and non-misleading. The FDA, however, recognizing that Amarin’s purpose in making these statements would be to promote an unapproved use of Vascepa, threatened to bring misbranding charges against Amarin if it did so. Amarin claimed that the FDA’s threat of a misbranding action chilled it from engaging in constitutionally protected truthful speech.
On May 7, 2015, Amarin sought preliminary relief to ensure its ability to engage in truthful and non-misleading promotion of Vascepa, free from the threat of a misbranding action. Amarin asserted in its complaint that the FDA’s current regulatory policy restricted the transmission of truthful information from manufacturer to physician about the off-label use of pharmaceuticals in a manner that violates the First Amendment of the U.S. Constitution (see Off-label speech restrictions should go overboard to fish-oil manufacturers lawsuit, Health Law Daily, May 11, 2015).
The issue of whether the FDA has authority to regulate statements about the unapproved uses of medicines has been around for some time. For example, in 2012, the Second Circuit overturned the criminal conviction of a sales representative who had promoted the off-label use of Xyrem®, a central nervous system depressant. The court held that the criminalization of the sales representative’s truthful and non-misleading statements was a violation of the sales representative’s speech rights (see Conviction for promotion of off-label use violated First Amendment, Health Law Daily, December 4, 2012).
District court ruling
On August 7, 2015, the Southern District of New York issued its ruling in favor of Amarin (see Hold your horses, FDA: no misbranding action for truthful off-label promotion, Health Law Daily, August 10, 2015). The court concluded that to avoid infringing on the First Amendment, the federal Food, Drug and Cosmetic Act must be construed by the FDA as not prohibiting or criminalizing the truthful off-label promotion of FDA-approved prescription drugs, where the off-label use itself is lawful, which the FDA had conceded.
The roadmap to Amarin’s off-label victory at the district court can be found via decisions in the last half decade that would eventually reach the U.S. Supreme Court in a matter concerning commercial speech. In Sorrell v. IMS Health, the high court concluded that commercial speech, including speech related to the marketing of drugs, is protected under the First Amendment as long it is not false or misleading (see Supreme Court favors pharmaceuticals in twin decisions, Health Law Daily, July 7, 2011).
Additional settlement terms
Additional elements of the proposed Amarin settlement include:
- The FDA has agreed to provide Amarin with an optional preclearance provision through 2020 for new off-label claims.
- The parties have agreed to a dispute resolution provision designed to avoid future litigation on matters arising under the settlement order.
- The court would retain jurisdiction over the matter to ensure compliance with and resolve any future dispute arising from the settlement order.
Clinical studies will continue
Amarin announced that it remains strongly committed to completing the ongoing REDUCE-IT cardiovascular outcomes study. This study is designed to test whether Vascepa, when added to statin therapy, will significantly reduce cardiovascular risk compared to statins alone in high-risk patients with elevated triglyceride levels.
Leveraging the Amarin victory
The pharmaceutical industry has taken notice of Amarin’s First Amendment victory and may be in the process of leveraging the decision to allow for more expansive drug indications via truthful off-label promotion. For example, on September 8, 2015, Pacira Pharmaceuticals, Inc. filed a lawsuit in the same federal court, seeking to prevent the FDA from bringing an enforcement action against Pacira for what it claims is truthful and non-misleading speech concerning its sole product, Exparel® (see Commercial speech waters turn murky, Health Law Daily, October 20, 2015).