Amarin sues FDA over 'free speech' issue the agency says it is ready to hash out

The FDA is inviting drugmakers to a meeting this summer to discuss off-label promos and free speech, but Amarin ($AMRN) figures it can't wait for the debate to play out. The Irish drugmaker, which reported another quarterly loss today, has sued the FDA for curtailing its free speech, namely being able to discuss off-label uses of its omega-3 capsule Vascepa that might spur some sales.

The lawsuit, filed in federal court in New York, claims the FDA rule prohibiting giving doctors information about potential unapproved uses "severely restricts medical professionals' access to information from the source most knowledgeable about the drugs: the drug manufacturers," Reuters reports.

The FDA has been sued over this concern before and the industry has been grumbling about the issue for some time, so the agency said yesterday it would allow experts to publicly hash the matter out. But it is a particularly poignant concern for Amarin. The drugmaker has only the one drug to rely on and has been unable to make any profit from selling it for the very limited use for which it is approved.

The data that Amarin likely wants to discuss is about Vascepa's effects on cardio outcomes. The drug is approved to treat adult patients with severe triglyceride levels, but the company has been fighting the FDA since 2013 when it reversed itself on a special protocol assessment. The FDA initially agreed that a significant drop in triglyceride levels in the drug's pivotal study would be enough to indicate an improvement in cardiac outcomes for a much larger group of patients. It changed course upon receiving new data and told Amarin it needed to finish up a trial that would provide more detailed information about its heart risks.

It was a tough blow for Amarin, which had to cut its staff in half to keep going. The company said today that sales of Vascepa hit $15.6 million for Q1, up from $11 million a year ago, as prescriptions in the quarter climbed by 66%. It also struck a deal in February with Eddingpharm to sell the capsules in China and other parts of Asia. But the gains were not enough for the company to avoid a $32 million loss.

Amarin's not the first to try the free speech approach to gain some edge in sales. In 2012, a federal appeals court overturned a conviction of a sales rep for pushing a drug based on studies of an unapproved use. And after the court specifically said that drugmakers can't be prosecuted for "speech promoting the lawful, off-label use of an FDA-approved drug," the industry has been pushing the FDA to revise its rules. Of course there will be critics at the forum as well. Public Citizen and other consumer advocates have already challenged the FDA over a proposal to allow drugmakers to at least give doctors published journal articles about off-label uses.

- here's Amarin's earnings release
- here's the Reuters story
- read the WSJ story (sub. req.)

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