By DAVID B. RIVKIN JR. And ANDREW GROSSMAN, May 21, 2015
We are free to tell you that a clinical trial shows the drug Vascepa to be an effective treatment for persistently high triglyceride levels. But should the drug’s manufacturer, Amarin, tell you or your doctor the same thing, the company would face criminal prosecution and civil liability. Therein lies a First Amendment anomaly, one that may finally be resolved by a lawsuit that Amarin filed earlier this month against the Food and Drug Administration.
The FDA has long banned promotion of drugs for uses other than those it has approved. Yet so-called off-label uses are legal and account for about 20% of all prescriptions. Some off-label uses of drugs have even become the standard of care for particular conditions.
But the drug’s manufacturer and its agents—and only them—cannot legally talk about this. Patients can—and do—discuss off-label uses of drugs endlessly in online forums. Doctors certainly exchange information about these uses.
But Amarin can’t say anything about the Vascepa trial. The drug is approved only as a treatment for “very high” triglyceride levels, not those that are merely persistently high. As a result, doctors and their patients are being kept in the dark about a treatment that, for some patients, has fewer side effects than other drugs.
The FDA claims its speech ban is a necessary part of its drug-approval process, which requires manufacturers to demonstrate efficacy for each intended use. The agency aggressively investigates and the government regularly prosecutes pharmaceutical companies and their representatives that promote off-label uses of their drugs. Yet once a drug is approved, doctors can prescribe it for any use—and the FDA recognizes, in its regulatory guidance—that such uses are essential to effectively translate medical research into improved health outcomes.