Amarin, FDA talking settlement

Originally published by Saul Perloff (US).

In a letter dated August 28, an attorney representing Amarin Pharma, Inc. advised the judge overseeing Amarin’s case against FDA, that “The parties have agreed to explore the possibility of settlement of this matter.”

In our recent post, we analyzed U.S. District Judge Paul Engelmayer’s August 7th decision granting Amarin’s motion for preliminary injunction against the FDA. Judge Engelmayer ruled that Amarin has a First Amendment right to make truthful and non-misleading statements about off-label uses of its prescription drug Vascepa. Shortly after issuing his ruling, the judge directed Amarin and the FDA to confer “as to the future course of and next steps in the case” and to report back to the court. Order, Amarin Pharma, Inc. v. U.S. Food & Drug Admin., Case No. 15-3588 (S.D. N.Y. Aug. 10, 2015).

In addition to reporting that the parties were exploring settlement, the August 28 letter, requested that further proceedings in the case be stayed until October 30. 2015, “on which date the parties will file a joint letter advising the Court of their views as to next steps in the case.”

 

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