The Medical Information Working Group, a coalition of Big Pharma companies including Bayer HealthCare, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline and Johnson & Johnson, filed an amicus brief in support of Amarin in its off-label lawsuit against the FDA.
PhRMA and the Washington Legal Foundation have also filed amicus briefs in support of Amarin.
Amarin’s complaint against the FDA argues that the regulator’s decision to tell the pharmaceutical company that it cannot talk about off-label uses of its triglyceride-lowering prescription medication with physicians violates the company’s First Amendment rights. The drug, Vascepa, is approved to treat patients with very high triglyceride levels, but Amarin said it has scientific evidence to support the drug’s use in patients with high triglyceride levels, too. The FDA has declined to approve the second indication because the regulator said the clinical trial data did not show a cardiovascular benefit among this second group of patients.
Amarin’s complaint said the drugmaker wants to discuss off-label benefits of Vascepa with healthcare providers as opposed to consumers. It also said in its complaint that the claims it is not allowed to discuss are the same ones dietary supplements can make.
Like PhRMA, MIWG’s brief argues that FDA regulations are vague. MIWG’s brief also said the group objects to the regulator’s “unfettered discretion to make after-the-fact ad hoc judgments about manufacturer speech.”
The FDA submitted a letter to the US District Court of the Southern District of New York and said it agrees that Amarin should be able to speak to healthcare professionals about the off-labels claims but provided some boundaries for the communications.
Unlike MIWG’s supporters, which count their annual sales in billions, Amarin’s annual report indicates the company had $54.2 million in revenue last year and $26.4 million in 2013. Net loss for those years was $56.4 million and $166.2 million, respectively.