On March 8, the U.S. Food and Drug Administration (FDA) and Amarin Pharma, Inc. entered into a settlement agreement resolving litigation brought by Amarin against the FDA related to Amarin's off-label promotion of Vascepa®, a drug used to lower fat levels. In August 2015 the federal district court in Manhattan ruled that the FDA could not prohibit Amarin from using truthful information to promote the drug, whether or not for an off-label use, because such a prohibition would violate Amarin's right to free speech.
Under the terms of the settlement the FDA agreed to be bound by the court's ruling to permit Amarin to market Vascepa® for the off-label use at issue (to treat patients with persistently high triglycerides), provided that Amarin assures that its promotion of such off-label use remains truthful and non-misleading. The settlement agreement also permits Amarin to submit a limited number of communications annually relating to additional proposed off-label uses of the drug to the FDA for preclearance through an expedited process through 2020.
Proponents of the court's ruling and the settlement argue that drug companies should have the right to inform doctors about the benefits of off-label uses of their drugs to support informed medical decisions for the benefit of patients. Critics argue that off-label drug promotion represents an end run around established FDA authority that prohibits drug companies from marketing drugs for uses the FDA has not approved. Whether the court ruling and settlement will significantly expand off-label marketing efforts by drug companies remains to be seen.
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