Amarin and FDA near settlement on off-label free speech, ask court for 30 more days

Amarin ($AMRN) and the FDA have indicated they are near to hashing out a legal settlement in their fight over what is considered a major free-speech issue for drugmakers and their right to discuss off-label drug uses. The two told a New York court they need at least another 30 days to get it done.

Dublin, Ireland-based Amarin in August won a declaratory judgment from a federal court that said 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 if what it is saying is truthful. The two then agreed to talk about a settlement. Amarin this week said the court has been asked to hold off on proceedings until March 18. Regulatory Focus said it is the third time they have asked for a short delay.

By settling the litigation, Amarin may get what it wants, and be free of costly litigation, and the FDA can avoid the potential for a federal precedent in an area that it is trying to get a better handle on.

The fight stems from Amarin's intention to discuss with doctors the benefits of its fish-oil derived med Vascepa, for off-label uses. The drugmaker has struggled to get traction for Vascepa, which 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 the FDA rejected it for the broader use, it said in its complete response letter that any effort to promote that way would be misbranding.

Amarin responded by suing the agency to allow it to tell doctors that Vascepa 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 trampled by the federal agency if it were not able to discuss such findings. The federal court sided with Amarin.

Since last summer's ruling, another drugmaker, Pacira, has filed suit looking for a court to grant it similar permission on the way it markets its pain drug Exparel. The FDA in 2014 sent the New Jersey company a warning letter for promoting Exparel for pain relief in surgeries not listed on its label but the company says its label is approved for general uses and not limited to specific surgeries.

The free speech case has been closely monitored by the industry because the FDA has brought actions against drugmakers for their off-label promotions of drugs, many of which have been settled for sums that reach into the billions of dollars. The FDA was dealt a setback in its efforts to control off-label promotions several years ago when a federal appeals court ruled in a specific case that a sales rep had a protected free-speech right to discuss off-label uses of a drug if what they said was truthful. The FDA has since been trying to fashion new guidelines about how much drugmakers can talk up off-label uses for their drugs. The industry has been paying rapt attention to all of these cases, too see how much leeway they might expect.

- here's Amarin's announcement
- more from Regulatory Focus

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