Court rules that FDA cannot restrict off-label marketing

A federal judge in New York has ruled that the Food and Drug Administration cannot restrict off-label marketing information for an approved drug so long as the information is truthful and not misleading. The judgment was based on the First Amendment—the right to free speech.

The judge, Paul A Engelmayer, issued an injunction prohibiting the FDA from bringing threatened action against Amarin Corporation for their marketing of Vascepa, a drug consisting of purified omega 3 fatty acid derived from fish oil.1

The FDA approved Vascepa for treating blood triglyceride concentrations above 500 mg/dL in 2011. But it objected to Amarin marketing the drug for treating patients with lower concentrations of triglycerides, despite evidence showing effectiveness from a study approved by the agency. The reason was a growing question as to whether …