Health Affairs

Health Affairs, 23, no. 1 (2004): 52-63 doi: 10.1377/hlthaff.23.1.52 © 2004 by Project HOPE	New Online   Getting Health Reform Done   After the State of the Union   Incremental Reform   E-Health in Developing World   Most-Read Articles in 2009

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Environment

The Political Economy Of FDA Drug Review: Processing, Politics, And Lessons For Policy

Daniel P. Carpenter

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.

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