Skin in the Game: Comparing the Private and Public Regulation of Isotretinoin

Abstract

This paper engages in a comparative institutional analysis of the private and public risk management programs of the drug isotretinoin, which are designed to prevent the undesired effects isotretinoin has on fetal development. This case study sheds light on the comparative effectiveness of private and public regulation in the pharmaceutical and health care markets. A range of evidence indicates that the private risk management program was more successful in reducing fetal exposures and educating patients about the harmful effects isotretinoin can have on a fetus than the FDA risk management programs designed to accomplish the same goals.