Tuesday, December 4, 2012
Back in 2011, the AJLM had a symposium issue anticipating major issues in 1st Amendment limits on FDA restrictions on off-label marketing. It was a prescient move. Just as it did in Sorrell, the Second Circuit is using free speech jurisprudence to significantly expand pharmaceutical companies' freedom of action to promote drugs:
The ruling, in United States v. Caronia, involved the conviction of Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive daytime sleepiness, known as narcolepsy. He was accused of promoting it to doctors as a treatment for insomnia, fibromyalgia and other conditions. . . .
“The government clearly prosecuted Caronia for his words — for his speech,” the majority wrote, concluding later “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 lone dissenting judge, Judge Debra Ann Livingston, vigorously disagreed, arguing that by throwing out Mr. Caronia’s conviction “the majority calls into question the very foundations of our century-old system of drug regulation.” She argued that if drug companies “were allowed to promote F.D.A.-approved drugs for nonapproved uses, they would have little incentive to seek F.D.A. approval for those uses.”
Judge Livingston also dissented in Sorrell, but her concerns were dismissed by a Supreme Court that (at least according to this essay) "declared 'information is speech,' a holding so broad and potentially far-reaching that the Court could not possibly have literally meant what it said."
How will pharma firms use their new freedom of maneuver? They have sponsored a great deal of research, and are sure to use many forms of information and advocacy to promote more off label uses. But cases like Caronia may end up a Pyrrhic victory, given a growing crisis of confidence about the validity of drug marketing strategies. As the Washington Post reported last week, "Doctors have grown deeply skeptical of research funded by drug companies." It's far too easy for firms to promote their rosiest results, while keeping negative outcomes out of the public eye.
As the First Amendment continues to undermine the extant FDA model of information control, it's time for the agency to take the logic of decisions like Sorrell and Caronia seriously, and to engage in more information dissemination. Make full clinical study reports available publicly, or, at the very least, to groups like the Cochrane Collaboration, whose analyses of Tamiflu are raising major concerns about its maker's efforts to promote its prophylactic purchase. The best way to deal with an off-label promotion "free for all" is to make critical information about drug effectiveness free, for all.
PS: For more background on the issue of biased research, check out the excellent video by Ben Goldacre below: