It looks like the federal court ruling last month that Amarin ($AMRN) had the "free speech" right to promote its fish oil product Vascepa for off-label use will become nettlesome to the FDA. A second drugmaker, Pacira, has now filed suit looking for a court to grant it similar permission on the way it markets its pain drug Exparel.
The FDA last year sent the New Jersey company a warning letter for promoting Exparel for pain relief in surgeries not listed on its label, Reuters reports. Its 2011 approval was based on studies in bunionectomies and hemorrhoidectomies.
In an emailed statement, the company explained that its pivotal trials were conducted in soft-tissue (hemorroidectomy) and hard-tissue (bunionectomy) models, which was consistent with the FDA's guidance for analgesics seeking a broad indication. The company said, Exparel is indicated for "administration into the surgical site to produce postsurgical analgesia" and the label does not specify any limitations to use based on surgery type.
The product generated sales of $197.6 million, last year, Reuters said, 95% of Pacira's revenue, so having its use restricted could be a big financial blow to the company.
In its action against the agency, Pacira claims the FDA is trying to limit its use after approval and that it has the right to promote it, even for off label uses, as long as its claims are truthful, Reuters reports. Pacira is leaning on last month's decision in a federal court, also in New York. In that case, a judge ruled that the FDA couldn't prohibit Amarin's "truthful" promotion of the omega-3 product for unapproved uses because doing so would violate the protection of free speech.
Vascepa is approved to treat patients with superhigh levels of triglyceride fat in their blood but Amarin was seeking approval to treat patients with lower triglycerides and sued in an effort to be able to promote the drug for use in that patient population. It has a study that shows that it does lower triglycerides in that population. When the FDA declined to approve it for that use, it pointed out there were studies questioning whether lowering triglycerides actually has much impact on preventing strokes or hearts attacks for patients with the condition. The FDA is expected to appeal the Amarin decision.
The difference in their cases, Pacira said in the email is that while "both Amarin and Pacira are seeking to share truthful information, in the case of Pacira, that truthful information is for approved, on-label uses of their product."
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 that many have settled for sums that reach into the billions of dollars. Doctors can use drugs for uses not approved by the FDA and often do but in the past some companies have cherry-picked studies and not always given doctors the full story on potential side effects. The FDA has been working for months on new guidelines for how companies can talk about their products.
When the Vascepa ruling was handed down, Joel Kurtzberg with Cahill Gordon & Reindel, the firm that represented Amarin, told the New York Times: "This is the first decision, I think, that clearly and unequivocally rebuffs the government's view that off-label promotion can be prosecuted, even if truthful and nonmisleading."
There soon may be a second.
- read the Reuters story
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