Off-label marketing: free speech or illegal promotion?

When Alfred Caronia worked a decade ago as a sales representative for Orphan Medical—now part of Jazz Pharmaceuticals—he marketed sodium oxybate for cataplexy but also promoted the drug for other unapproved uses. In 2008 he was convicted of introducing a misbranded drug into interstate commerce for talking up unapproved uses. However, his conviction was overturned by a US appeals court panel last month after he successfully argued that his First Amendment rights were violated because the federal government failed to prove his remarks were false or misleading, potentially opening the doors for increased off-label marketing.

Off-label marketing is hardly new, of course. Physicians in the US are free to prescribe medications for uses not approved in product labeling, but the federal government has successfully reached settlements with dozens of drug makers for violating the Food, Drug and Cosmetic Act, which prevents them marketing a drug for unapproved uses. Recently, though, there has been some push back.

Several drug makers have filed lawsuits against the US Food and Drug Administration to argue that the agency is stifling commercial speech. Par Pharmaceutical, for instance, contended that its right to convey “truthful” information to physicians is protected by the First Amendment yet is thwarted by FDA regulation. The lawsuit is pending.

And so the Caronia decision capped an increasingly intense debate about the rights of drug makers to discuss use of their medicines for specific purposes, even when these uses are not approved by the FDA. And the ruling quickly sparked debate about the extent to which off-label marketing might now become more pervasive and what the FDA …