This Article contends that there are two distinct theories of the offense of off-label promotion—the informational theory and the institutional theory. One is concerned with controlling the flow of medical knowledge and the other is concerned with protecting regulatory legitimacy. Different kinds of evidence are key under each theory. I argue that although the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its accompanying regulations emphasize the informational theory, federal prosecutors rely more heavily on the legal arguments that underpin the institutional theory of enforcement. A corollary to this contention is that the informational theory of off-label promotion does most of the work in determining the evolution of FDA policy and guidance with respect to drug marketing and labeling. The institutional theory, on the other hand, drives the blunt force of government enforcement, meant to give the regulatory system it protects an extra measure of deterrent power. I briefly summarize these two theories below.
Miguel A. Lopez,
The Informational and Institutional Theories of Off-Label Promotion,
San Diego L. Rev.
Available at: https://digital.sandiego.edu/sdlr/vol49/iss3/10