Court Ruling Allows Amarin to Promote Vascepa Off-Label

Amarin Pharmaceuticals has a constitutional right to promote its cholesterol-lowering drug Vascepa for an off-label use as long as the communication is truthful and not misleading, a New York federal judge ruled — dealing a blow to FDA efforts to prevent off-label drug promotion.

The ruling in Amarin Pharma Inc., et. al v. Food and Drug Administration et. al. allows the Irish drugmaker to make statements and disclosures to doctors regarding use of Vascepa (icosapent ethyl) to treat patients with persistently high triglycerides, even though it lacks FDA approval for that population.

This is the first decision that clearly and unequivocally rebuffs the government’s view that off-label promotion can be prosecuted even if truthful and nonmisleading speech is used, says Joel Kurtzberg, a partner at Cahill Gordon & Reindel, who represented Amarin in the case.

Amarin sued the FDA in May after the agency repeatedly rejected its request to promote the drug to a wider patient population. The company claimed it should be allowed to tell physicians that Vascepa can help lower triglyceride levels in patients whose levels are between 200 and 499 mL/dL of blood, and who are already taking statins, even though its approved indication is for an adjunct to diet in patients with triglyceride levels over 500.

The FDA urged the court to deny Amarin’s motion for an injunction, arguing that allowing Amarin to promote the off-label use could set a precedent that would return the U.S. to a pre-1962 era, when companies weren’t required to prove the safety and efficacy of drugs for each intended use.

Ruling Based on Caronia

Judge Paul Engelmayer of the U.S. District Court for the Southern District of New York disagreed.

Under the Second Circuit’s ruling in United States v. Caronia, “misbranding is unlike the crimes of jury tampering, blackmail, and insider trading to which the FDA has analogized, in which ‘the speech is the act,’” Engelmayer said. “Where the speech at issue consists of truthful and nonmisleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based.”

The ruling provides Amarin with preliminary relief. The judge said he will issue a separate order soon regarding next steps in the litigation, which could include a motion for a permanent injunction.

Amarin said it plans to begin promotional activities consistent with the ruling as soon as possible. The FDA declined to comment. — Jonathon Shacat