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Fish oil firm fights FDA for off-label use

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Fish oil firm fights FDA for off-label use

A biopharmaceutical company has sued the U.S. Food and Drug Administration in federal court for the right to market its fish oil pill for off-label use.

In the complaint, filed Thursday in the U.S. District Court for the Southern District of New York, Dublin-based Amarin Corp. P.L.C. alleges that the FDA has infringed on its First Amendment right to “engage in truthful and non-misleading speech … even if that speech is off-label promotion.”

Based on a clinical trial, the FDA approved the marketing of Amarin's fish oil pill, Vascepa as a dietary supplement, “for use as an adjunct to diet to reduce triglyceride levels in adult patients with very high triglycerides,” the complaint states. “Because FDA has approved Vascepa for this use, doctors are lawfully permitted to prescribe Vascepa for any use that, in their medical judgment, is in the best interests of their patients.”

“FDA regulations forbid promotion of drugs for unapproved or 'off-label' uses, even if such promotion is entirely truthful and presented in a non-misleading manner,” according to the complaint.

In workers compensation, off-label use is seen primarily in pain management, experts have said.

According to Amarin's complaint, the company has conducted a clinical trial to demonstrate that Vascepa “reduces triglyceride levels and has other favorable effects in adult patients with persistently high triglycerides.” While the FDA does not dispute the success of this trial, it “refuses to approve the promotion of Vascepa for” broader uses than as a dietary supplement, the complaint states.

The FDA's indication for the drug states that “patients should be placed on an appropriate lipid-lowering diet and exercise regimen before receiving Vascepa and should continue this diet and exercise regimen with Vascepa.”

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