Risk-Taking and Rulemaking: Addressing Risk Compensation Behavior Through FDA Regulation of Prescription Drugs

Abstract

Despite widespread acclaim for their potential to reduce public health harms, technological advances in health and safety frequently raise the ominous specter of risk compensation behavior-the possibility that individuals protected by these technologies will increase their risk-taking on the belief that they are protected from harm. Risk compensation has been a rallying cry for opponents of new technologies such as the HPV vaccine, needle exchange programs for drug users, or prescription pills for the prevention of HIV infection. Although these concerns are frequently voiced in the language of morality and personal responsibility, it may be more productive to consider this phenomenon through the lens of behavioral science, with an emphasis on respecting individuals' behavioral preferences. This Article aims to present the theoretical basis for risk compensation behavior, to categorize diferent types of risk compensation effects, to enumerate ways in which the law may address these effects, and to illustrate an application of these legal strategies to FDA regulation of prescription drugs. Throughout, this Article reframes risk compensation behavior as a presumptively rational mechanism for value conversion, by which the protective value of a health or safety technology is transformed into another type of value that may better satisfy individual preferences. But where imperfect information or negative externalities lead to harm, there may be a role for a regulatory response.