Amarin Pharma and FDA agree settlement permitting off label promotion of Vascepa (icosapent ethyl)for high triglycerides.

Amarin Pharmaceuticals will be able to promote its cholesterol drug Vascepa (icosapent ethyl) for off-label uses after resolving differences with the FDA in a free speech case involving off-label promotion of the capsules. Under the settlement, the FDA has agreed to be bound by the August 2015, ruling in Amarin Pharma Inc., et. al v. Food and Drug Administration et. al. that allowed the company to engage in truthful and non-misleading speech promoting the off-label use of Vascepa.

Amarin had filed a declaratory judgment action in the U.S. District Court for the Southern District of New York last May,to declare its off-label promotion of Vascepa as constitutionally protected free speech. The company had contended that results of a study had shown that the drug reduces triglyceride levels. While the agency did not dispute the results of the study, it refused to approve the promotion of Vascepa for use in this patient population.

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. 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.

Comment:The FDA stated that the decision is specific to this case and the decision is not to be interpreted as opening for off label promotions. A further case brought by Pacira is before a Federal Court relating to off label promotion of Exparel to pain surgeries.