Big Pharma Attacks FDA in Amarin Free-Speech Lawsuit
PhRMA and the Medical Information Working Group want the FDA to clarify its rules around manufacturer promotion of off-label drug use and are using a small drugmaker’s lawsuit against the agency to press their case.
In an amicus brief filed in U.S. District Court for the Southern District of New York on Thursday, PhRMA accuses the FDA of relying on guidance it acknowledges isn’t binding and that “contains significant caveats that preserve the government’s option to pursue criminal and civil enforcement based on manufacturers’ protected speech.”
MIWG — whose members include Bayer, Eli Lilly, GlaxoSmithKline and other major drugmakers — says the FDA routinely announces its interpretation of rules through “nonbinding pronouncements,” including guidances, lawsuits and case-specific enforcement letters. The group filed a separate brief in the ongoing lawsuit, Amarin Pharma Inc., et. al v. Food and Drug Administration et. al.
Unapproved uses of prescription drugs are integral to the practice of medicine, the groups say, adding 80 percent of drugs given to children and more than half of those administered to cancer patients are for off-label uses.
Amarin sued the FDA in May claiming that it should be able to recommend that physicians prescribe its cholesterol-lowering drug Vascepa (icosapent ethyl) outside its approved indication as an adjunct to diet in patients with high levels of triglycerides.
The agency wrote to the drugmaker on June 5, saying it didn’t have concerns with much of the information Amarin wants to communicate and wouldn’t consider the information to be false or misleading. — John Bechtel