Cease-and-desist regulation and reintegrative shaming: The case of the direct-to-consumer advertising of prescription drugs

Abstract

Adopting aspects of John Braithwaite's "reintegrative shaming" theoretical framework, the authors evaluate the effectiveness of the Food and Drug Administration's (FDA's) "cease-and-desist" regulation of the Direct-to-Consumer Advertising (DTCA) of prescription drugs in the United States. This is accomplished in two ways: First, the authors examine the legislative record concerning drug marketing in the United States, drawing attention to how the inception of the FDA and the mode of "cease-and-desist" regulation predict many of the agency's problems in regulating DTCA. Second, the authors analyze the regulatory practices of the Division of Drug Marketing and Communications (DDMAC)-the division of the FDA that is responsible for DTCA oversight. Drawing attention to the ways in which pharmaceutical companies repeatedly violate FDA policy, the authors conclude that "cease-and-desist" regulation severely limits DDMAC's ability to enforce compliance. Indeed, the examples of repeated violations of FDA policy may imply that such violations are an expected part of DTCA campaigns. The authors conclude with a model that outlines how reintegrative shaming may be applied to DTCA regulation.