FDA, Amarin reach settlement on off-label use promotion

NEW YORK — Amarin announced Wednesday that New York’s Southern District Court had approved its proposed settlement with the Food and Drug Administration, reached Tuesday, over the promotion of off-label use for its Vascepa (icosapent ethyl) capsules. 

 

The settlement terms allow Amarin to promote off-label use for Vascepa, as long as it is truthful and non-misleading. A judge in August declared that the FDA would limit the company’s first amendment rights if it prevented Amarin from sharing with physicians truthful data that supports a use the FDA hasn’t approved.

 

“We are pleased to announce this amicable resolution with and among the physician plaintiffs, FDA and the U.S. government and look forward to continuing to promote Vascepa in a truthful, non-misleading and responsible manner,” Amarin president and CEO John Thero said. “With more truthful and non-misleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides.”