Skin in the game: comparing the private and public regulation of isotretinoin

Abstract

AbstractThis 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 healthcare markets. A range of evidence indicates that the private risk management program successful in reducing pregnancies and educating patients about the harmful effects isotretinoin can have on a fetus. These findings challenge a consensus found in the medical literature that the private program needed to be supplanted and contain implications for future risk-management policy in healthcare.