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.
The only real explanations for the FDA’s conduct are maintaining tight control over pharmaceutical companies and bureaucratic aggrandizement.
The FDA’s ban on discussing off-label drug uses is indefensible under First Amendment law. The speech it bans is truthful, not misleading, and concerns a lawful activity. Yes, the government has a substantial interest in drug safety and public health, but banning truthful speech on health issues won’t advance public health. Drug manufacturers know more about their products than anyone else. The off-label promotion ban denies doctors’ and patients’ abilities to make informed and intelligent treatment decisions. As the Supreme Court recognized in Sorrell v. IMS Health Inc. (2011)—which struck down a state law prohibiting the sale of prescribing data to pharmaceutical companies—“information can save lives.”
Blocking such information could cost lives. New uses for existing treatments are discovered all the time. The recent Ebola outbreak, for example, prompted researchers to evaluate the efficacy of existing antiviral drugs against the disease, hoping to find an off-label match. That process continues for survivors who face lingering symptoms. When Dr. Ian Crozier, an Ebola survivor, was recently found to still harbor the virus in his eye, doctors successfully treated him with an experimental antiviral drug. Another recent example is Rapamune, an immunosuppressant approved for use in kidney transplants that has been found to suppress certain types of cancers, including of the lung.
A prohibition on the promotion of off-label drug uses by means of false or misleading information—in other words by fraud—would surely pass constitutional muster. Moreover, the FDA could also assist doctors and patients in sorting through information regarding off-label uses, much as it already provides safety information for approved uses on its website. The agency could even ban particular off-label uses where this was necessary to protect public health.
But the FDA has no intention of loosening its grip. In 2012 the Second Circuit Court of Appeals overturned—on First Amendment grounds—the conviction of a pharmaceutical sales rep for talking to physicians about the off-label uses of narcolepsy drug Xyrem. However, the agency has not appealed the decision in United States v. Caronia, most likely to avoid an adverse ruling by the Supreme Court that would apply across the country.
Unfortunately, even if the government loses the Amarin case, it will again probably forgo an appeal. This would enable the FDA to continue enforcing a flagrantly unconstitutional policy by default. The best prospect for a cure may lie in Congress.
Messrs. Rivkin and Grossman are attorneys with the BakerHostetler firm in Washington, D.C.