The Changing Landscape of the Commercial Speech Doctrine and FDA Advertising Regulation: Off-Label Marketing in the Wake of Sorrell v. IMS
Office of Chief Counsel, Food and Drug Administration
May 31, 2012
This paper discusses the FDA’s drug labeling regulatory regime, including restrictions on promoting drugs for uses other than those explicitly approved by the FDA, and the current developments in First Amendment jurisprudence that may lead to a drastic departure from the FDA’s current marketing restriction practices in the near future. Part II of this paper outlines the drug approval process and defines the contours of a drug’s “label.” This includes a definition of off-label marketing and a discussion of the potential consequences of “misbranding.” Part III surveys the commercial speech doctrine and how recent developments in First Amendment jurisprudence, including IMS v. Sorrell and Citizens United, have altered the traditional understanding of acceptable restrictions on commercial communications. This section will compare the rationales used in past cases upholding FDA advertising restrictions and argue that Sorrell implies these rationales will no longer be sufficient, at least insofar as the marketing restrictions apply to communications directed at physicians rather than the lay public. Part IV applies these developments by using the Allergan complaint as a roadmap to a potential challenge, and suggests what a potential future regime might look like if the FDA’s off-label regulations are overturned.
Number of Pages in PDF File: 38
Keywords: FDA, Sorrell, Citizens United, Commercial Speech, Allergan, First Amendment, Food and Drug Administration, Off-Label Promotion, Off label
Date posted: June 2, 2012