Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA

A large-scale theoretical, historical and statistical analysis of pharmaceutical regulation in the United States as it is carried out by the U.S. Food and Drug Administration (FDA). This project has been funded by the National Science Foundation (SES-0076452, for "Formal and Empirical Analyses of Bureaucratic Delay: The Case of FDA Drug Review") (2000-2003), the Robert Wood Johnson Foundation Scholars in Health Policy Program (1998-2000), a Robert Wood Johnson Foundation Investigator Award in Health Policy Research (2004-2006), and the PriceWaterhouse Coopers Endowment for the Business of Government. None of these foundations or entities in any way endorses, or is otherwise responsible for, the contents of this Web site or Web page, or for any papers produced or claims found herein. Professor Carpenter neither seeks nor accepts research funding or any other form of compensation from the FDA, from private entities that may sponsor product applications to the FDA or that are otherwise regulated by the FDA, from patient advocacy groups or from consumer advocacy groups (e.g., Public Citizen). In addition, Professor Carpenter does not directly own stock or any other form of asset in any company regulated by the FDA. Reviews and Reactions: Tyler Cowen's treatment at Marginal Revolution Steven Teles' review in the Washington Monthly James Surowiecki's discussion in The New Yorker Ezra Klein's discussion in thinking about regulatory status [Washington Post and Newsweek] Other references and reviews from Fall 2010 onward: Gardiner Harris' story on Frances Kelsey [New York Times] A broadside from the pharmaceutical left: Marcia Angell's review in the New York Review of Books [subscription required] and my response (in print) and a more thorough response with a catalog of her many errors and mischaracterizations. The original response posted on September 20 is here , and my response to Angell's rejoinder in the NYRB is posted separately here. A broadside from the pharmaceutical right: anti-regulatory conservative Henry Miller's review in Issues in Science and Technology. Review in Nature Chemistry Review in Lancet