Amarin will be allowed to tell doctors about studies showing that its proprietary fish-oil product, Vascepa, may be effective for indications not approved by the FDA, under a settlement reached with the agency, .
The settlement means the FDA will not appeal a previous court ruling in Amarin's favor, which was widely seen as opening the door to much broader off-label marketing of drugs and devices.
That ruling stated that Amarin -- and, presumably, any other drug company -- is free under the First Amendment to "engage in truthful and non-misleading speech" about its products, even if that speech is about unapproved uses.
Vascepa (icosapent ethyl) is currently approved to reduce triglycerides in adults with severely elevated levels. Amarin had been seeking the right to tell physicians about research suggesting that it reduces cardiovascular event risk. The FDA had argued that such claims had not yet been approved and thus were illegal under its regulations.
In announcing the settlement, Amarin said it remained committed to completing an ongoing clinical trial called that it hopes will demonstrate such a benefit.