Second Circuit Holds Food, Drug and Cosmetic Act Does Not Prohibit Off-Label Promotion


In a significant blow to the U.S. government’s enforcement efforts against the pharmaceutical industry, a panel of the Second Circuit overturned the conviction of a pharmaceutical sales representative for conspiracy to promote an FDA-approved drug for off-label uses, holding that the Federal Food, Drug and Cosmetic Act (“FDCA”) does not“prohibit[] and criminaliz[e] the truthful off-label promotion of FDA-approved prescription drugs.” United States v. Caronia, No. 09-5006, slip op. at 51 (2nd Cir., Dec. 3, 2012). In reaching its decision, the majority opinion of the 2-1 decision concluded that permitting the government to prosecute someone for “speech promoting the lawful, off-label use of an FDA-approved drug” runs afoul of the First Amendment. Id. Although clearly a major defeat for the government, the practical implications of the decision remain unclear, both because the decision will most likely undergo further appellate review and because it makes clear the government can continue to pursue off-label cases where the off-label promotion involves false or misleading statements.

The Majority Opinion -

Alfred Caronia, a sales representative with pharmaceutical company Orphan Medical, Inc. – later acquired by Jazz Pharmaceutical – was convicted after a jury trial of conspiracy to introduce a misbranded drug into commerce in violation of the FDCA, 21 U.S.C. §§ 331(a) and 333(a)(1). Caronia, slip op. at 3. Caronia hadpromoted Xryem, a powerful central nervous system depressant FDA approved to treat narcolepsy, to physicians for use in disease states and subpopulations for which the FDA has not approved use (“off-label”uses). Id.

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