Reform of Drug Regulation — Beyond an Independent Drug-Safety Board

Abstract

The authors argue that extensive reform of the system of drug regulation in the United States is needed to improve drug safety. In order to develop a more comprehensive system that is not so narrowly focused on testing of drugs before marketing, the authors propose a new federal authority for drug regulation, to be made up of three independent centers: a Center for New Drug Approval, a Center for Post-marketing Studies, and a Center for Drug Information.