REPUTATION AND POWER
Organizational Image and Pharmaceutical Regulation at the FDA
This is a web page for my book Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton: Princeton University Press, 2010). There are many papers and other writings associated with this project, and you can find these at my FDA Project home page.
Reputation and Power has been awarded The 2011 Allan Sharlin Memorial Award of the Social Science History Association for outstanding Book in Social Science History.
Reviews and Reactions
Some early reactions to the book have discussed it in light of our current regulatory dilemmas around the world.
Ezra Klein's discussion in thinking about regulatory status [Washington Post and Newsweek]
Other references and reviews from Fall 2010 onward (selected, not exhaustive):
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.
Data and Documentation
NME Approval Time Data [.csv] -- This data set, which was used for the book and for a forthcoming article in the Journal of Law, Economics and Organization, represents what is perhaps the most comprehensive datatset on FDA drug approval available in a single location.
Over the coming months I will post various archival documents of interest, particularly where these are not protected by copyright (as in the case of federal archives).