The U.S. Food and Drug Administration and drug company Amarin announced late Tuesday the proposed settlement terms of a lawsuit about off-label drug promoting: Amarin will be allowed to market its fish-oil product, Vascepa (icosapent ethyl), for unapproved indications.
According to the settlement, the FDA will not appeal a previous court ruling in Amarin’s favor, which said that Amarin is free under the First Amendment to disseminate truthful information to promote its drug, even if it’s for unapproved uses.
Vascepa is currently approved by the FDA to reduce triglycerides in adults with severely elevated levels. Dublin-based Amarin has been seeking the right to send physicians promotional materials about research suggesting that the drug reduces cardiovascular event risk.
Amarin said it remained committed to completing an ongoing clinical trial, REDUCE-IT, in hopes that it will prove that benefit.
“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,” John Thero, president and CEO of Amarin, said in a prepared statement.
The FDA said in a statement that the settlement applied only to the Amarin case — and that the agency’s position on whether pharmaceutical companies have a constitutional right to provide “non-misleading information” to promote off-label use has not changed.
However, some experts are saying the settlement could set a dangerous precedence, in allowing other drug makers to seek similar arrangements to promote their products for unapproved uses.
Read the New York Times article.
Filed Under: Drug Discovery