As U.S. expenditures on prescription drugs continue to rise and account for a growing share of gross national product, Daniel P. Carpenter, Ph.D. examines a major institution in American health care: the U.S. Food and Drug Administration (FDA). His project, Reputation and Regulation: A Study of Pharmaceutical Policy at the FDA, considers the power the FDA exerts and how political, social, and other considerations influence its decisions. Focusing on the Center for Drug Evaluation and Research (CDER), the agency's drug reviewing division, Dr. Carpenter dissects the FDA's reputation for protecting the American public, the evolution of that role, and its impact on regulation of new drugs. Specifically, he explores how the FDA's concerns about its image and credibility affect whether drugs are approved or rejected, and whether drug development is accelerated or slowed. His work should also reveal who wins and who loses when agency self-protection motivates the making of prescription drug policy.

Daniel Carpenter is the Allie S. Freed Professor of Government at Harvard University. He graduated from Georgetown University in 1989 with distinction in Honors Government. He received his doctorate in political science from the University of Chicago in 1996. He taught as assistant professor of politics at Princeton University from 1996 to 1998, and from 1998 to 2000 was a Robert Wood Johnson Scholar in Health Policy in residence at the University of Michigan. He joined the Harvard University faculty in 2002. Dr. Carpenter's primary interest is in the theoretical, historical and quantitative analysis of public bureaucracies and government regulation. His dissertation received the 1998 Harold D. Lasswell Award from the American Political Science Association and as a book - The Forging of Bureaucratic Autonomy: Reputations, Networks and Policy Innovation in Executive Agencies, 1862-1928 (Princeton: Princeton University Press, 2001) - was awarded the APSA's Gladys Kammerer Prize as well as the Charles Levine Prize of the International Political Science Association. In his brief career, Carpenter has won six different best paper or publication awards for his research. He is a two-time winner of the Herbert Kaufman Award for the Best Paper presented in the Public Administration Section of the American Political Science Association. He has been a fellow at the Center for Advanced Study in the Behavioral Sciences at Stanford, California, at the Brookings Institution Research, and the Santa Fe Institute. He has also been the recipient of grants from Princeton University for teaching innovations. More recently, Professor Carpenter has commenced a large-scale theoretical, historical and empirical analysis of the regulation of pharmaceutical products by the U.S. Food and Drug Administration (FDA). Carpenter's research on pharmaceutical regulation has been awarded grants from the National Science Foundation and an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation. He is interested in how the FDA has come to possess broad gate keeping power over the international pharmaceutical marketplace, and he will study the immense variance of time-to-market and FDA review times across different drugs, as well as why drug safety issues arise with different sorts of products and at different times. His paper Groups, the Media and Agency Waiting Costs: The Political Economy of FDA Drug Approval, was awarded the 2001 Pi Sigma Alpha Award for the Best Paper presented at the 2000 Midwest Political Science Association, and was published in the July 2002 edition of 'American Journal of Political Science'. More recently, Professor Carpenter's article, Protection without Capture: Product Approval by a Politically Responsive, Learning Regulator, in the November 2004 issue of the 'American Political Science Review' exposes fundamental logical and technical flaws in the classic "capture" arguments of Nobel Laureate George Stigler and offers a more compelling alternative model of regulation and regulatory politics. Current work (joint with Michael Ting of Columbia) examines regulatory error and the interplay between R&D and regulation. Professor Carpenter has also been working on health policy research in two areas. He has authored mathematical models of "placebo learning," or the influence of placebo effects on how patients and doctors evaluate the quality of medical services and pharmaceutical therapies, and the economic and regulatory implications. And with Elizabeth Armstrong (Princeton) and Marie Hojnacki (Penn State), he is working on a large empirical project on coverage of disease in the mass media and in public forums such as congressional hearings. In addition to political science, history and social science journals, he has published in ‘Nature Reviews,' ‘Archives of Internal Medicine,' and ‘Health Affairs.'