Second Circuit Court of Appeals Holds “Off-Label” Promotion is Protected Free Speech – United States v. Caronia

Alfred Caronia, a pharmaceutical sales consultant for Orphan Medical, Inc., was convicted of conspiracy to introduce a misbranded drug into interstate commerce in violation of the Federal Drug and Cosmetic Act (“FDCA”). Caronia appealed the conviction and argued that the conviction rested solely on his speech in violation of the First Amendment. In a 2-1 split decision, the Second Circuit Court of Appeals agreed with Caronia and vacated the conviction.

Caronia promoted the drug Xyrem for “off-label” use. An off-label use is generally defined as using a drug for a purpose other than what has been approved for by the U.S. Food and Drug Administration (“FDA”). In this case, Xyrem is a powerful central nervous system depressant whose primary active ingredient is “GHB,” which is federally classified as the “date rape drug.” The FDA has approved Xyrem for only two medical indications.

Caronia was unknowingly recorded while promoting Xyrem for medical indications not approved for by the FDA, as well as subpopulations that had not been approved. The government alleged that Caronia was marketing Xyrem for medical indications he knew were not approved for by the FDA and that he knew Xyrem’s labeling lacked adequate directions and warnings for such uses. Thus, the government argued, Caronia conspired to introduce a misbranded drug into interstate commerce in violation of the FDCA.

On appeal, Caronia’s primary argument focused on the constitutionality of the misbranding provisions of the FDCA as interpreted by the government at trial. In addressing Caronia’s arguments, the court found that the FDCA provisions effectively regulate content, favoring one type of speech over another – “on-label” speech versus “off-label” speech. The court also found the provisions discriminated amongst speakers, penalizing only certain individuals — namely pharmaceutical manufacturers. These findings led the three-judge panel to examine the FDCA provision in question under the “strict scrutiny” standard of review.

Under the strict scrutiny standard of review, the government must show that the provision or regulation at issue is narrowly tailored to serve or promote a compelling government interest. In this case, the court found that while the FDA has a compelling interest in ensuring drug safety, public health, and the effectiveness and integrity of the FDA drug approval process, the FDCA’s misbranding provision does not directly advance the government’s interest; the off-label use of such drugs continues to be generally lawful. It also found that the provision is not narrowly tailored to further the interests served. The court stated the FDA might pursue a number of alternatives without excessive First Amendment restrictions.

Ultimately, the court concluded that Caronia’s conviction rested entirely on his speech and that under the court’s strict scrutiny analysis, the First Amendment required that his conviction be vacated.

The Second Circuit’s analysis is applicable to facts and circumstances similar to that of Caronia; it declined to address whether the FDCA provision as a whole is unconstitutionally invalid. Further, while this opinion has significant implications, it remains to be seen if the FDA will reconsider and revise it’s current approach to “off-label use” promotion of FDA-approved products.

The Maryland attorneys at Lebowitz & Mzhen can assist victims of medication errors, who have been injured by drugs prescribed, dispensed, or administered incorrectly. Contact us today online or at (800) 654-1949 for a free and confidential consultation to discuss your case.

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