Court rules that FDA cannot restrict off-label marketingBMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h4367 (Published 11 August 2015) Cite this as: BMJ 2015;351:h4367
- Bob Roehr
- 1Washington DC
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 …
Log in using your username and password
Log in through your institution
Register for a free trial to thebmj.com to receive unlimited access to all content on thebmj.com for 14 days.
Sign up for a free trial