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Off Label Marketing – First Amendment Challenge Ruling

Posted in Clinical Trials & Research/FDA, Pharma & Medical Devices, State & Federal Audits, Investigations & Litigation, Uncategorized

Written by Ellyn L. Sternfield

The U.S. Court of Appeals for the 2nd Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing, http://www.ca2.uscourts.gov/decisions.   Given the number of off-label marketing cases pursued by the government in recent years, this decision could have major repercussions.  But it is important to recognize the limits of the court’s December 3rd ruling.

The Food Drug and Cosmetic Act’s (FDCA) misbranding provisions, 21 U.S.C. Sections 331 and 333, are traditionally used by the government to prosecute off-label marketing cases:  intentional off-label marketing cases prosecuted as felony misbranding violations and strict liability cases as misdemeanor violations.   The government asserts that when a drug is marketed for uses not approved by the FDA, the drug is misbranded because its existing label does not adequately address the off-label uses.

In a split decision, the appellate court found that in convicting Caronia for conspiracy to introduce a misbranded drug into interstate commerce under the FDCA, the government prosecuted Caronia for his speech alone, which was not permissible under the First Amendment.  The court was persuaded by the fact the government never contended that Caronia said anything untrue or misleading about the drug products at issue, just that he promoted the products for uses not approved by the FDA.   The court was also guided by the Supreme Court’s 2011 decision in Sorrell v. IMS Health, holding that speech in aid of pharmaceutical marketing is a form of expression protected by the First Amendment.  With that precedent, the appellate court ruled that truthful off-label promotion was not tantamount to misbranding under the FDCA and reversed Caronia’s conviction.

But the appellate court did not strike down any portion of the FDCA.  And the court did not limit the government’s authority to prosecute individuals or entities under the FDCA for off-label marketing which is allegedly false or misleading, such as alleged suppression of clinical study results or misrepresentation of the extent of FDA approval.  What the court did say is that truthful off-label promotion of an FDA approved drug, without anything more, is protected speech and cannot be prosecuted as misbranding under the FDCA.

It is doubtful this ruling will mark the end of the Caronia case.  This was a split decision; the dissent persuaded that the defendant’s off-label marketing was merely evidence of the misbranding, so that Caronia’s conviction was not based on his speech alone.   Motions, potential rehearings, and an eventual appeal to the Supreme Court are likely next steps.  But with the plethora of pending off-label marketing cases, both criminal cases and parallel civil False Claims Act cases, we can be sure that government attorneys, defense attorneys, and whistleblower attorneys will all be paying close attention to what happens next.