Daniel P. Carpenter Ph.D.
Director of the Social Science Academic Ventures Program
Allie S. Freed Professor of Government
Harvard University
Email: dcarpenter@gov.harvard.edu
Discipline: Political Science
Expertise: Politics and Policymaking, Disease Advocacy, Interest Groups, Pharmaceutical Policy
Investigator Award 
Reputation and Regulation: A Study of Pharmaceutical Policy at the FDAAward Year: 2003 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.
Background 
Daniel Carpenter is Allie S. Freed Professor of Government and Director of the Social Science Academic Ventures Program in the Radcliffe Institute at Harvard University. He graduated from Georgetown University in 1989 with distinction in Honors Government and received his doctorate in political science from the University of Chicago in 1996. He taught previously at Princeton University (1995-1998) and the University of Michigan (1998-2002). He joined the Harvard University faculty in 2002. Dr. Carpenter's primary interest is in the theoretical, historical and quantitative analysis of American political development, public bureaucracies and government regulation, particularly regulation of health products. 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. His newly published book on pharmaceutical regulation in the United States is entitled Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton: Princeton University Press, 2010). In 2011, Carpenter was awarded the Allan Sharlin Memorial Award of the Social Sicence History Association for this book. Professor Carpenter has held fellowships from the John Simon Guggenheim Foundation, the Radcliffe Institute for Advanced Study, the Center for Advanced Study in the Behavioral Sciences, the Brookings Institution and the Santa Fe Institute. He has received grants from the National Endowment for the Humanities, the National Science Foundation, the Robert Wood Johnson Foundation (Scholars in Health Policy 1998-2000, Investigator Award in Health Policy Research 2004-2007) the Alfred Sloan Foundation and the Russell Sage Foundation.
- Carpenter, D., Joffe, S. A Unique Researcher Identifier for the Physician Payments Sunshine Act. JAMA, May 18 2011, 305(19): 2007-2008.
- Carpenter, D., Kesselheim, A., Joffe, S. Reputation and Precedent in the Bevacizumab Decision. NEJM, Jul 14 2011, 365: e3.
- Carpenter, D.P., Moffitt, S., Moore, C.D., Rynbrandt, R., Ting, M., Yohai, I., Zucker, E. Early Entrant Protection in Approval Regulation: Theory and Evidence from FDA Drug Review. Journal of Law, Economics, and Organization, Dec 2010, 26(3): 515-45.
- Carpenter, D., Zucker, E.J., Avorn, J. Drug-Review Deadlines and Safety Problems. NEJM, 2008, 358(13): 1354-61.
- Carpenter, D., Sin, G. Policy Tragedy and the Emergence of Regulation: The Food, Drug, and Cosmetic Act of 1938. Studies in American Political Development, 2007, 21(Fall): 149-80.
- Carpenter, D., Ting, M.M. Regulatory Errors with Endogenous Agendas. American J of Political Science, 2007, 51(4): 835-52.
- Carpenter, D. Reputation, Gatekeeping and the Politics of Post-marketing Drug Regulation. Virtual Mentor: American Medical Association Journal of Ethics, Jun 2006.
- Armstrong, E., Carpenter, D., Hojnacki, M. Whose Deaths Matter? Mortality, Advocacy, and Attention to Disease in the Mass Media. JHPPL, 2006, 31(4): 729-72.
- Carpenter, D. A Proposal for Financing Postmarketing Drug Safety Studies by Augmenting the FDA User Fees. Health Affairs Web Exclusives, 2005, 24(Supp 3): W5-469-80.
- Carpenter, D., Ting, M. The Political Logic of Regulatory Error. Nature Reviews Drug Discovery, Sep 23 2005.
- Carpenter, D., Fendrick, M. Accelerating Approval Times for New Drugs in the U.S.. Regulatory Affairs Journal, 2004, 15(6): 411-17.
- Carpenter, D. Gatekeeping and the FDA's Role in Human Subjects Protection. Virtual Mentor: American Medical Association Journal of Ethics, Nov 2004.
- Carpenter, D. Protection without Capture: Product Approval by a Politically Responsive, Learning Regulator. American Political Science Review, 2004, 98(4): 613-31.
- Carpenter, D. Staff Resources Speed FDA Drug Review. JHPPL, 2004, 29(3): 431-42.