The dispute stems from two conflicting federal appeals court rulings. In March 2013, the Ninth Circuit Court of Appeals in San Francisco upheld the 2009 conviction of Scott Harkonen, who is the former CEO of drug company InterMune. Harkonen was convicted of wire fraud for writing and distributing a press release that touted the off-label use of a medication that FDA approved only for treatment of severe osteoporosis. The press release was based on Harkonen’s manipulation of study data, and Harkonen actually said he would “cut that data and slice it until [he] got the kind of results [he was] looking for,” the court’s ruling said.
His lawyer argued that Harkonen’s statements were protected by the First Amendment and that the statements were part of “genuine scientific debate.” The appeals court disagreed, saying it was clear that Harkonen’s aim was to defraud and that he had a financial incentive to do so. Harkonen’s lawyer says he plans to appeal, although no appeal had been filed at press time.
Alternately, in December 2012, the Second Circuit Court of Appeals overturned the conviction of drug-company sales representative Alfred Caronia. Caronia was charged with promoting the off-label use of a central-nervous-system depressant medication that’s approved to treat narcolepsy. The off-label uses that Caronia promoted included treatment of insomnia and fibromyalgia. The federal appeals court ruled that the conviction restricted Caronia’s right to “commercial speech,” as long as his statements were truthful, saying the government can’t prosecute companies “for speech promoting the lawful, off-label use of an FDA-approved drug.”
FDA decided not to appeal the Caronia decision, because it doesn’t believe that the decision “will significantly affect the agency’s enforcement” of medication-misbranding laws, Clark-Lynn tells Consumers Digest. Nonetheless, the Second Circuit Court effectively ruled that FDA marketing restrictions for off-label use of medication violates free speech as long as the communication is truthful, whereas the Ninth Circuit ruled that FDA may restrict off-label marketing to some degree. As a result, FDA marketing restrictions for off-label use of medications is an issue that the Supreme Court eventually will have to resolve, says Marcia Boumil, who is a lawyer and professor at Tufts.
Some medical experts whom we interviewed worry that a Supreme Court decision that sides with drugmakers could be the first step toward dismantling FDA’s 75-year-old system that’s designed to protect consumers against unscrupulous medication sales. The Second Circuit Court ruling indicates that it isn’t the responsibility of the government to help doctors and consumers to sort through marketing claims—no matter how misleading they might be—and to make good decisions about medications, says Aaron Kesselheim, who is a professor of medicine at Harvard Medical School. Kesselheim was among the authors of a February 2013 article in Journal of the American Medical Association that called the Second Circuit Court’s position “disturbing.” We agree.
If the Supreme Court’s 2010 ruling on corporate-campaign contributions is any indication, consumers have every right to fear the worst. In that case, the Supreme Court ruled that campaign contributions by corporations and unions are protected by the First Amendment, which has been interpreted by consumer advocates to mean that the Supreme Court supports broader free-speech rights for corporations. As a result, doctors are bracing for the possibility that the Supreme Court will rule that FDA doesn’t have the right to regulate how drugmakers market their medications for off-label use, which would take away even the limited protection that FDA can provide to consumers.
How worried that consumers should be depends on whom you ask. For instance, Boumil insists that “we are still a long way from a situation where drug companies can promote snake oil without oversight.” However, Soller says consumers face “a perfect storm” when it comes to off-label drug use. He predicts that the Supreme Court will allow off-label marketing as an element of free speech, as long as the claims that drugmakers publish aren’t false. Of course, the studies on which drugmakers rely to market the off-label use of their medications often are based on evidence that’s as thin as the paper on which the studies are printed, independent experts tell us.