FDA settles with drug company on promotion of fish-oil pill for unapproved uses
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Version 0 of 1. The Food and Drug Administration has decided not to appeal a federal judge’s ruling that drug maker Amarin has a First Amendment right to promote its fish-oil pill for unapproved uses, as long as the information it provides doctors is truthful and not misleading. The company announced Tuesday that it had settled the case with the agency, in a move that will allow Amarin to continue to communicate with physicians about off-label uses for its drug, Vascepa. The settlement solidifies a ruling last August by U.S. District Judge Paul Engelmayer, who said the company had the right to distribute “truthful and non-misleading” information about uses beyond those for which Vascepa had been approved. The FDA had approved the drug for people with abnormally high levels of triglycerides, but Amarin wanted to market it to a broader range of patients. The case has been watched because of a broader issue: whether the First Amendment ensures that pharmaceutical companies can promote drugs for uses that the FDA has not yet declared safe and effective. Although doctors can prescribe medication for uses that aren’t included in a drug’s label, companies have been restricted from marketing drugs for such conditions. In a statement Tuesday, Amarin Chief Executive John Thero said the settlement “serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides.” The FDA underscored that the case was narrow and specific, involving a single drug and a single company. “This settlement is specific to this particular case and situation,” the agency said in a statement, “and does not signify a position on the First Amendment and commercial speech.” |