The Political Economy of FDA Drug Review: Processing, Politics.......

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The Political Economy of FDA Drug Review: Processing, Politics and

Lessons for Policy

Posted 01/07/2004

P. Carpenter

Abstract and Introduction

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.

read the rest here:

http://www.medscape.com/viewarticle/466261_1