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www.fdanews.com/articles/175666-fda-settlement-allows-amarin-to-promote-drug-for-off-label-use

FDA Settlement Allows Amarin to Promote Drug for Off-Label Use

March 9, 2016

Amarin Pharmaceuticals will be able to promote its cholesterol drug Vascepa 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 Aug. 7, 2015, ruling in Amarin Pharma Inc., et. al v. Food and Drug Administration et. al. that allowed the drugmaker 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, asking Judge Paul Engelmayer to declare its off-label promotion of Vascepa constitutionally protected free speech. The company had contended that results of a study had shown that the drug reduces triglyceride levels. While the agency didn’t dispute the results of the study, it refused to approve the promotion of Vascepa for use in this patient population.