FDA, Amarin Discuss Settlement Options Following Vascepa Ruling

Amarin is asking a New York federal court judge to halt further litigation with the FDA over off-label promotion of its cholesterol-lowering drug Vascepa until Oct. 30, while the parties discuss possible settlement options.

The request, filed in August in the U.S. District Court for the Southern District of New York, follows last month’s ruling that Amarin may promote the use of Vascepa (icosapent ethyl) to treat patients with persistently high triglycerides, even though it lacks FDA approval for that population, so long as the communication is truthful and nonmisleading.

As part of that ruling, Judge Paul Engelmayer directed Amarin and the FDA to confer and submit a joint letter on the next steps in Amarin Pharma Inc., et. al v. Food and Drug Administration et. al.

Susan Burnett, a partner with Bowman and Brooke, expects the FDA’s strategy in settlement talks will be to limit the damage of the court’s ruling. If the Second Circuit Court of Appeals were to affirm the decision, then the outcome would be much worse from the FDA’s perspective.

The FDA may believe it can craft a settlement that is as specific as possible to the Amarin case, thereby minimizing other drug companies’ ability to use the case as a “safe harbor,” Burnett said. Some of the promotional statements Amarin wants to make are permitted by the FDA for sellers of over-the-counter dietary supplements.

Once this case is settled, expect the FDA to focus on proving specific off-label promotions are false or misleading, rather than declaring all off-label speech illegal, Burnett says.

Attorney Ralph Hall, with Faegre Baker Daniels, expects more litigation over the First Amendment right to off-label promotion. Speaking at an FDAnews-sponsored debate on the topic, he said the agency is waiting for the right case to legally resolve the issue.

Amarin and the FDA declined to comment on the upcoming discussions. — Jonathon Shacat