US Court of Appeals in NYC reverses conviction of pharmaceutical sales representative who promoted off-label drug use (Monday, December 3, 2012).
The Second Circuit Court voted 2 to 1 to overturn conviction, citing the Freedom of Speech Clause of the First Amendment.
The FDA approves drugs for indications specified in a product’s label. And while doctors can prescribe a drug for any therapeutic purpose they see fit, pharmaceutical companies are allowed to promote a drug only for its FDA-approved uses.
Traditionally, pharmaceutical companies put in place robust clinical programs investigating the ongoing benefit of their products within the approved indication, as well as exploring other potential areas where products may prove useful. Demonstrated clinical benefit in indications outside a product’s approved labeling often results from such programs, with corresponding data presented in peer-reviewed publications. Despite the demonstrated benefit and availability of data in the public domain, findings that are off-label have historically been considered strictly off limits for promotional use.
United States v. Caronia
Pharmaceutical sales representative Alfred Caronia was convicted in 2008 for improper (i.e. off-label) promotion of Xyrem® (sodium oxybate) oral solution, indicated for the treatment of narcolepsy. He allegedly spoke about the use of Xyrem in unapproved areas, including fibromyalgia and insomnia.
Caronia’s conviction was overturned December 3, 2012 on First Amendment grounds of freedom of speech. The US Court of Appeals for the Second Circuit in Manhattan decreed that the government prosecuted Caronia for his words. The Supreme Court has previously held (Sorrell v. IMS Health, Inc., 2011) that “Speech in aid of pharmaceutical marketing … is a form of expression protected by the Free Speech Claus of the First Amendment.”
Of note, the three Circuit Judges in Caronia’s appeal were divided 2 to 1. Lone dissenting judge, Judge Debra Ann Livingston, commented, “… 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 FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses.”
FDA may need to broaden its view of proven product benefit
The US Supreme Court may be asked to rule on the constitutionality of FDA regulation of pharmaceutical promotion. However, the Caronia case suggests that pharmaceutical representatives may, in the near future, be allowed to speak about results from clinical studies in off-label indications—which could change everything we have known about what is and is not allowable in pharma. If this judgment holds, it will necessitate the FDA taking a broader view of clinical trial findings that differ from or amend data presented in approved product labeling. Whether they will or will not remains to be seen.
How do you think this ruling will impact the future of sales representative communications? Please share your comments.