Amarin Settles Off-Label Promotion Case Against the FDA

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The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion.

On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in the off-label promotion case, Amarin Pharma, Inc. v. US Food and Drug Administration, finalizing the much-anticipated settlement that the parties had proposed to the court earlier that day. The Amarin case garnered close attention in the life sciences industry after Judge Engelmayer granted the plaintiffs’ motion for preliminary injunction on August 7, 2015, holding that the First Amendment does not permit the US Food and Drug Administration (FDA) to criminalize Amarin Pharma, Inc.’s (Amarin’s) truthful and non-misleading speech promoting the off-label use of its FDA-approved drug, Vascepa. This settlement comes on the heels of a string of cases in which the industry has successfully invoked the First Amendment to challenge the FDA’s off-label promotion regulatory regime.

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