On Friday, Amarin ($AMRN) won what was being called a First Amendment free speech victory for drugmakers. It got a federal court to say the FDA cannot bar Amarin from discussing off-label use of its fish-oil drug Vascepa for a wider group of patients than it is approved for.
It is not clear how big a victory the ruling will be given it came in a lawsuit Amarin brought against the FDA as a defensive move. The FDA had never sued to stop Amarin. And it comes after the FDA has already said most of the material Amarin wants to use for marketing purposes is fine with it anyway. It is also a preliminary ruling, although U.S. District Judge Paul Engelmayer in Manhattan said that based on what he saw, Amarin is likely to win a permanent injunction, Reuters reports.
Amarin has been struggling to gain traction for Vascepa, a fish oil-derived pill that competes with GlaxoSmithKline's ($GSK) newly generic Lovaza. Vascepa is approved only for lowering extremely high triglyceride levels, an indication much narrower than Amarin had hoped for. While trials showed the drug did, in fact, lower high blood lipids it targets, it did not show it actually prevented coronary artery disease.
When Amarin was unable to persuade the FDA to broaden Vascepa's approval to patients with high triglycerides at high risk of coronary artery disease--a much larger population--it sued the agency to allow it to tell doctors that it did lower blood lipids and that research shows that can be good for patients with heart disease. It argued its First Amendment rights would be trammeled by the federal agency if it were not able to discuss such findings.
|FDA's Janet Woodcock|
But in May, the FDA's Janet Woodcock told Amarin in a letter that the "FDA does not have concerns with much of the information you proposed to communicate."
Off-label use of drugs is permitted and often happens, but the FDA gets really concerned when education becomes pure marketing and risks get downplayed in the process. Plenty of federal litigation resulting in multibillion-dollar settlements has pointed to drugmakers using these kinds of tactics.
A federal appeals court upheld one sales rep's right to discuss off-label drug uses--as protected free speech, as long as it's truthful. Since then, the FDA has been working on new guidelines about how much drugmakers can talk up off-label uses for their drugs. Still, the industry is watching the Amarin case closely for signs of how much leeway they might expect or whether a court might undercut the FDA's effort and give them more room to maneuver.
- here's the Reuters story