Pharmaceutical sales and marketing departments are buzzing across the country today following the Appeals court overturn of a 2008 off-label marketing conviction. Alfred Caronia, an Orphan Medical sales rep, was convicted of pushing the narcolepsy drug Xyrem for uses not approved by the FDA. In the appeal, Caronia claimed his First Amendment rights were violated. This week, the 2nd Circuit Court of Appeals agreed, tossing Caronia’s conviction on free speech grounds. As quoted by U.S. Circuit Judge Denny Chin, “The government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetics Act] for speech promoting the lawful, off-label use of an FDA-approved drug.” As reported by Bloomberg, the court itself cited off-label prosecutions, mentioning several cases, including the $3 billion settlement with GlaxoSmithKline earlier this year.
Over the years, drugmakers have already argued the free speech defense. In 2009, Allergan sued the FDA on free speech grounds, stating it should be allowed to promote Botox for unapproved uses. This ruling will no doubt send ripples through the pharma industry – right into the doctor’s office. How could this change the way that the pharmaceutical industry promotes their products directly to physicians? Given that doctors are able to prescribe medications for off-label use, sales reps are now able to exercise their free speech and talk with the doctors more freely about their uses. Will this lead to increased face time with docs? Perhaps lead to a potential increase in drug revenue?
Another key point is how the FDA will react to the Appeals court ruling. Will fines still be enforced for off-label promotion when it is considered free speech and not in promotional materials? And depending on how the FDA responds, will this open the door for increased public discussion on off-label use?
Certainly an issue worth watching – one that may end up all the way at the Supreme Court. The ruling will clearly have an impact on the industry, but I caution drugmakers to tread lightly before jumping on off-label marketing opportunities.