FDA: Amarin Can Promote Off-Label Use for Vascepa

Amarin announced that settlement terms have been reached to resolve the Amarin First Amendment litigation (Amarin Pharma Inc. et al. v. FDA et al.) regarding Vascepa (icosapent ethyl) capsules.

According to the terms, the Food and Drug Administration (FDA) and the United States government have agreed to be bound by the August 2015 judicial declaration that Amarin may participate in “truthful and non-misleading speech promoting the off-label use of Vascepa.” This includes the use of Vascepa to treat patients with persistently high triglycerides, and “such speech may not form the basis of prosecution for misbranding,” according to the order of settlement. The Company’s expanded promotion of Vascepa will continue as planned.

Other major terms of the settlement include:

Amarin bears the responsibility of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.
The settlement terms are to be interpreted consistently with the August 7, 2015 opinion and order and are not to be construed to limit Amarin’s constitutional rights to free speech concerning Vascepa.
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.

Vascepa, a lipid-regulating agent, was approved as adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. An ongoing cardiovascular outcomes study, REDUCE-IT, is evaluating whether Vascepa will significantly reduce cardiovascular risk when added to statin therapy vs statins alone in high-risk patients with elevated triglyceride levels.

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