FDA Allows Omega-3 Company to Market Product for Unapproved Use

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

The FDA on Tuesday agreed to allow the makers of the omega-3 pill Vascepa (icosapent ethyl) to market it for an unapproved use — to lower triglycerides in patients with high levels — the New York Times reports. The drug is currently approved to lower triglycerides only in those with extremely high levels (≥500 mg/dL).

The company, Amarin, sued the FDA in 2015 for the right to market Vascepa to a larger group of patients. In August, a federal judge said the agency "could not prohibit Amarin from using truthful information to promote its drug, even for unapproved uses, because doing so would violate the company's right to free speech," the Times reports.

Dr. Michael Carome of Public Citizen told the Times: "This really sends a signal to other companies that if you want to engage in off-label promotion, you can negotiate with the FDA."

In a statement, the FDA said Tuesday's settlement "is specific to this particular case and situation, and does not signify a position on the First Amendment and commercial speech."