Abstract

In February 2012, the US Food and Drug Administration (FDA) announced the Rx-to-OTC switch approval of oxybutynin in the form of Oxytrol® Transdermal System for women suffering from overactive bladder (OAB). This regulatory decision is a potentially important advance in self-care that may fill the gap in undertreatment of OAB in the U.S. Furthermore, the switch decision carries with it regulatory science implications for how FDA undertakes benefit-risk assessments for switch, especially in light of the agency’s recent publication of its structured qualitative descriptive approach to pharmaceutical benefit-risk decision making. This paper includes an introductory perspective of the potential significance of OAB as an OTC indication, an overview of the pivotal dataset supporting the switch of transdermal oxybutynin to OTC status, and a discussion of FDA’s qualitative descriptive approach to benefit-risk in the context of Rx-to-OTC switch.