Healthy Skepticism Library item: 20364

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Carpenter DP
The Political Economy Of FDA Drug Review: Processing, Politics, And Lessons For Policy
Health Affairs 2004 Jan; 23:(1):52-63
http://content.healthaffairs.org/content/23/1/52.abstract

Abstract:

U.S. Food and Drug Administration (FDA) drug review bears a structural similarity to many decisions made by other regulatory agencies: high uncertainty, low reversibility, avoidance of observable error, and high political stakes that induce lobbying by interested parties. This paper explores the policy lessons to be learned from viewing FDA drug review as a politically shaped exercise in information processing. I argue that the incentives facing regulators induce limits on the degree to which drug review can be accelerated, that the same incentives could render privatization initiatives problematic, and that political pressures could play a useful role in identifying priority drugs.