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US Court of Appeals for the Second Circuit Rules FDA’s Ban on Off-Label Marketing of Drugs Violates First Amendment’s Guarantee of Free Speech

In US v. Caronia, 703 F. 3d 149 (2d Cir. 2012), a pharmaceutical sales representative, Alfred Caronia, appealed a judgment of the United States District Court for the Eastern District of New York, which convicted him of conspiracy to introduce a misbranded drug into interstate commerce in violation of the Federal Drug and Cosmetic Act (FDCA).  Caronia contended that he was convicted for his promotion of the off-label use of an approved prescription drug (Xyrem).  According to Caronia, he was convicted for his speech, in violation of this right to free speech under the First Amendment. 

The United States Court of Appeals for the Second Circuit, in an opinion authored by Circuit Judge Denny Chin on December 3, 2012, agreed with Caronia and vacated the judgment of conviction.  In reaching this decision, the Court reviewed and considered the Supreme Court’s opinion in Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011). 

In determining whether there was speech restrictions on pharmaceutical marketing, the Court in Sorrell engaged in a two-step inquiry.  First, the Court considered whether the government regulation restricting speech was content- and speaker-based.  If it was, the regulation was subject to heightened scrutiny and “presumptively invalid.”  The second prong the Court considered was whether the speech was protected by the First Amendment. 

In applying this inquiry in Caronia, the Court determined that the FDCA’s misbranding provisions to prohibit off-label marketing is both content-based and speaker-based, and thus, subject to heightened scrutiny.  The second prong required applying a four-part test, originally set forth in Central Hudson v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980).  More specifically, in order to warrant First Amendment protection: (1) the speech in question must not be misleading and must concern lawful activity, (2) the asserted government interest must be substantial, (3) the regulation must directly advance the governmental interest asserted, and (4) the regulation must be “narrowly drawn” and may not be more extensive than necessary to serve the interest. 

Although the majority found that the government’s construction of the FDCA as prohibiting off-label marketing meets the first two parts of the Central Hudson test, the majority found that it does not withstand scrutiny under the third or fourth part.  Thus, the majority held that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.  Circuit Judge Debra Ann Livingston, finding, among other things, that the third and fourth part of this test was met, filed a vigorous dissent.  


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