Historical and Theoretical Studies

Awarded The 2011 Allan Sharlin Memorial Award of the Social Science History Association for Outstanding Book on Social Science History

Early 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

Data and Documentation

NME Approval Time Data [.csv] -- This data set, which was used for the book and for a Fall 2010 article in the Journal of Law, Economics and Organization, represents what I believe to be the most comprehensive historical data set on FDA drug approval. At present it runs from 1950 to 2006, and we will be updating it to relfect more recent drug approvals. Susan Moffitt was my primary collaborator in setting up this data, and thanks to David Dranove and David Meltzer for sharing some of their data. Comments and corrections are most welcome.

Codebook [brief descriptions of variables]


Over the coming months I will create a new page where various archival documents of interest from the book are available (particularly where these are not protected by copyright, as in the case of federal archives).

Other Historical Studies

Bioequivalence: The Regulatory Career of a Medical Concept (with Dominique Tobbell), Bulletin of the History of Medicine 85 (1) (Spring 2011) 93-131. Presented at the AIHP Conference on Modern Medicines, Madison, Wisconsin, October 2008; and at "Unbranding Medicines: The Politics, Promise, and Challenge of Generic Drugs," Harvard University, December 2008.

Policy Tragedy and the Emergence of Economic Regulation: The Food, Drug and Cosmetic Act of 1938, Studies in American Political Development 21 (2) (Fall 2007) 149-180 (with Gisela Sin).

"Robust Action and the Strategic Use of Ambiguity in a Bureaucratic Cohort: FDA Scientists and the Investigational New Drug Regulations of 1963," (with Colin Moore). In Formative Acts, ed Stephen Skowronek and Matthew Glassman, University of Pennsylvania Press, 2007.

"The Ambiguous Emergence of an Organizational Identity: Pharmaceutical Regulation at the FDA, 1947-1961"; manuscript presented at the Boston University American Political History Seminar, Fall 2005; to be presented at Rutgers University Health Policy Seminar, January 2006; Yale University American Politics Workshop, January 2006; Stanford University Law School, March 2006.

"The Continuous Crystallization of an Organizational Reputation: The FDA in Public, Scientific and Congressional Audiences, 1962-1990." Presented at the CARR Conference on Risk and Regulation, Plenary Lecture, Centre for the Analysis of Risk and Regulation (CARR), London School of Economics, March 2007; presented at the Sociology Department Workshop, Northwestern University, April 2007.

Essays and Policy Relevant Studies

Reputation and Precedent in the Bevacizumab Decision (with Aaron Kesselheim and Steven Joffe), New England Journal of Medicine 365 e3 (July 14, 2011). [A July 2011 interview on the FDA's regulation of bevacizumab (Avastin) for HER-2 negative metastatic breast cancer appears at the Pharmalot site (interview in pdf).]

Reputation, Gatekeeping, and the Politics of Postmarket Drug Regulation, AMA Virtual Mentor (The American Medical Association), 8 (June 2006): 403-6.

The Political Logic of Regulatory Error (with Mike Ting), Nature Reviews – Drug Discovery, 4(10) (October 2005): 819-23. [PubMed link]

A Modest Proposal for Financing Drug Safety Regulation through User Fee Augmentation, Health Affairs (Web Exclusive) W5-469, October 18, 2005. For some relevant discussion, see Simon Frantz’s articles “How to Avoid Another Vioxx” and “Vioxx Fears Prompt Call for User Fee Evaluation” at Nature Online.

Gatekeeping and the FDA's Role in Human Subjects Protection, AMA Virtual Mentor (The American Medical Association), November 2004.

Accelerating Approval Times for New Drugs in the United States, The Regulatory Affairs Journal – Pharma, 15 (6) (June 2004): 411-417.

The Political Economy of FDA Drug Approval: Processing, Politics and Lessons for Policy, Health Affairs 23 (1) (January/February 2004): 52-63.

Staff Resources Speed FDA Drug Review: A Critical Analysis of the Returns to Resources in Approval Regulation, Journal of Health Politics, Policy and Law, 29 93) (June 2004), 431-442.

Approval Times For New Drugs: Does The Source Of Funding For FDA Staff Matter?, with Michael Chernew, A. Mark Fendrick, and Dean Smith. Health Affairs (Web Exclusive) December 17, 2003, W3-618-624.

Statistical Output for Selected Model Runs for this Piece

Models using Time-Varying Covariates: The CDER Staff Effect Persists even when Submission-Year Averaging is Relaxed

Amicus Curiae Brief for Wyeth v. Levine case (Supreme Court, 2008-2009 term)