As we reported last August, U.S. District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015, article. Shortly afterward, Amarin and the government entered settlement talks. August 31, 2015 update. We are now able to report that on March 8, 2016, the parties entered into a proposed Settlement Agreement resolving all causes of action in Amarin’s suit against the FDA.
In June 2015, Amarin had sought to enjoin the FDA from prohibiting claims about Vascepa’s efficacy in patients with “persistently high triglyceride levels” when its approved indications had been restricted to patients with “very high triglyceride levels.” In his August 7, 2015, Opinion and Order, Judge Engelmeyer granted Amarin’s motion for a preliminary injunction reasoning that under Caronia, Amarin may make truthful and non-misleading statements promoting Vascepa’s potential benefits for patients with persistently high triglyceride levels without fear of prosecution. Op. & Order.
Read the rest of the article at the Norton Rose Fulbright Brand Protection Blog.