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Insurance regulation in Asia Pacific
Ten things to know about insurance regulation in 19 countries.
Publication | March 2016
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.
In a series of settlement activities that began in August 2015 and culminated yesterday, the parties reached a proposed agreement ending the underlying suit.
In resolving the case, FDA agreed that Amarin may promote Vascepa for patients with persistently high triglycerides notwithstanding the fact that the drug is not approved for that indication. In addition, FDA agreed that Amarin's speech was truthful and not misleading.
Going forward, the parties agreed to the following key provisions:
Amarin appears to have solidified its ability to promote Vascepa without regard to FDA's approved labeling as long as that promotion is truthful and not misleading. Together with the FDA's recent settlement with Pacira, this case signals the dramatic impact the Second Circuit's decision in Caronia may have on FDA's regulation of off-label promotion.
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Ten things to know about insurance regulation in 19 countries.
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