Amarin Sues FDA Over Off-Label Vascepa Promotion

Dublin, Ireland-based Amarin Pharmaceuticals is asking a New York federal court to declare its off-label promotion of a cholesterol-lowering drug constitutionally protected free speech, after several FDA rejections of its desire to promote the drug for a wider patient population.

The crux of Amarin Pharma Inc., et. al vs. Food and Drug Administration et. al. is whether Amarin should be able to recommend that physicians prescribe Vascepa (icosapent ethyl) outside its official 2012 FDA indication as an adjunct to diet in patients with triglyceride levels over 500 mL/dL of blood.

While the FDA officially disallows such off-label promotion, Amarin claims it should be allowed to tell physicians that Vascepa can help lower triglyceride levels in patients whose levels are between 200 and 499, and who are already taking statins, not only because this is “truthful and non-misleading,” but also because the practice is commonplace.

“Prescribing drugs such as Vascepa to treat patients with persistently high triglycerides is recommended by numerous cardiovascular treatment guidelines and position statements that are based on strong scientific and clinical support linking high triglycerides, high non-HDL cholesterol, and cardiovascular disease,” Amarin’s suit claims.

Additionally, Amarin argues, the FDA has allowed other manufacturers of similar fenofibrates, niacin and another omega-3 fatty acid-based drugs and nutritional supplements to promote their products for this patient population.

While PhRMA declined to comment on this case, Vice President and Senior Counsel Jeff Francer said Friday that the trade group has long believed the FDA’s provisions regarding drug promotion are inadequate. The proper way to fix the problem, though, is to amend the FDA’s laws, not turn to the courts, he said.

This is Amarin’s third go at the FDA over this drug. It appeared after Vascepa’s first approval that the agency was amenable to helping the company expand the drug’s indication, granting a special protocol assessment based on a trial Amarin was conducting to show that lowering triglycerides in patients with below-500 triglyceride levels could improve overall health and lower the incidence of heart disease.

But in fall 2013, regulators yanked the special protocol assessment based on a safety signal that Amarin hadn’t been asked to assess. Amarin appealed twice and lost both times.

The FDA declined to comment, as the case is pending. Read Amarin’s complaint at www.fdanews.com/05-08-15-Amarincase.pdf. — Lena Freund