The Caronia decision represents (a) a significant development in the regulation of pharmaceutical sales and marketing practices and, more broadly, (b) another example of the recent judicial expansion of corporate free speech rights.

In this article, Shareholder John S. Summers and Associate Dylan J. Steinberg discuss the U.S. Court of Appeals for the Second Circuit’s recent opinion in United States v. Caronia, which is a welcome addition to the body of appellate law in this area of off-label marketing of pharmaceuticals. This closely watched and long-awaited appeals court decision calls into question the constitutionality of the FDA’s enforcement regime regarding off-label marketing.

This article was originally published in The Legal Intelligencer.

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