On December 3 2012, in a widely anticipated ruling, the US Court of Appeals for the Second Circuit reversed the conviction of pharmaceutical sales representative Alfred Caronia for misbranding under the Federal Food, Drug and Cosmetic Act, based on alleged off-label promotion.(1) In a two-to-one opinion, the court concluded:

"[W]e decline to adopt the government's construction of the [Federal Food, Drug and Cosmetic Act]'s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech. We construe the misbranding provisions of the [Federal Food, Drug and Cosmetic Act] as not prohibiting and criminalizing the truthful off-label promotion of [Food and Drug Administration]-approved prescription drugs."(2)

The court agreed with Caronia that the government's prosecution had been based solely on speech promoting off-label uses. It found that the government's attempt to punish such speech through the act's misbranding provisions amounted to speaker and content-based restrictions. Thus, heightened First Amendment scrutiny would apply under Sorrell v IMS Health, Inc.(3) The court concluded that the prosecution could not survive even intermediate scrutiny under Central Hudson Gas & Electric Corp v Public Service Commission.(4)

For further information on this topic please contact Paul E Kalb, Coleen Klasmeier or Jeffrey M Senger at Sidley Austin LLP by telephone (+1 202 736 8600), fax (+1 202 736 8711) or email ([email protected], c[email protected] or [email protected]).


(1) The full ruling can be accessed at www.ca2.uscourts.gov/decisions/isysquery/ad42db66-2109-490d-9585-eba2a3144b95/3/doc/09-5006_complete_opn.pdf.

(2) Slip op at 51.

(3) 131 S Ct 2653 (2011).

(4) 447 US 557 (1980).