F.D.A.’s ‘Off-Label’ Drug Policy Leads to Free-Speech Fight
It certainly seems odd that speaking the truth can violate the law. Yet the Food and Drug Administration takes the position that when it approves a drug for a particular treatment, the manufacturer of that drug cannot promote it for other uses even if those statements are true.
But that policy has been called into question in a decision by Judge Paul A. Engelmayer of the Federal District Court in Manhattan, who found that the First Amendment protects drug companies that want to make truthful statements about their drugs, even if it is for an unapproved use. His decision sets up a likely appeal to determine just how far the government can go to punish speech that is truthful.
The case arises out of a provision of the Food, Drug and Cosmetic Act that prohibits pharmaceutical companies from selling a drug if it is “misbranded.” The F.D.A. takes the position that a drug manufacturer’s statements about its product are limited to promoting its “intended use,” which is the particular treatment for which it was approved. If a company wants to promote a drug or medical device for a non-F.D.A. approved use, known as off-label, then it must undertake additional clinical trials to receive approval before it can tell doctors about it.
Amarin Pharma, a small drug manufacturer, challenged the F.D.A. when it sought to promote the off-label use of its cardiovascular health drug, Vascepa, for patients with a different condition. An F.D.A.-approved study showed that the use of the drug was effective, but the agency had denied approval for use by those patients.
The company and four doctors sued the F.D.A. after it threatened to bring civil charges against them if they used the study to help sell off-label use of Vascepa. They claim that the agency’s rule on off-label promotion violates their First Amendment right to free speech, asking the district court to block any enforcement action.
Judge Engelmayer sided with the company, pointing out the many incongruities in the F.D.A.’s approach to off-label marketing. The agency does not prohibit doctors from prescribing medications for nonapproved uses because it does not have direct authority over them. The judge pointed out that “the therapeutic — indeed, sometimes lifesaving — value of off-label uses of F.D.A.-approved drugs has been widely recognized.” For some conditions “off-label prescription is the norm rather than the exception,” a fact the F.D.A. is aware of and even encourages on occasion.
A 2012 appeals court decision played a crucial role in Judge Engelmayer’s analysis. In United States v. Caronia, the United States Court of Appeals for the Second Circuit in Manhattan overturned the conviction of a sales representative caught on tape promoting an unapproved use of a drug to a group of doctors. In a 2-1 decision, the appeals court found that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the F.D.C.A. for speech promoting the lawful, off-label use of an F.D.A.-approved drug.”
The key to Judge Engelmayer’s decision is that the statements Amarin wants to make are truthful and not misleading, as the F.D.A. largely acknowledged. He found that the decision in the Caronia case prevents the agency from taking any enforcement action based on statements about a drug that are true.
The First Amendment protects truthful speech, but as the Supreme Court pointed out in Illinois v. Telemarketing Associates, it “does not shield fraud.” Other courts have rejected First Amendment challenges to the F.D.A.’s prohibition of off-label promotion in cases that included charges of fraud for misleading doctors and the agency about the use of drugs and medical devices.