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Groups, the Media, Agency Waiting Costs, and FDA Drug Approval

Daniel P. Carpenter
American Journal of Political Science
Vol. 46, No. 3 (Jul., 2002), pp. 490-505
DOI: 10.2307/3088394
Stable URL: http://www.jstor.org/stable/3088394
Page Count: 16
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Groups, the Media, Agency Waiting Costs, and FDA Drug Approval
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Abstract

Why does the FDA approve some drugs more quickly than others? I model drug review as a process of bureaucratic learning. Political influence occurs when politicians, firms, disease-specific organizations, and the media shift the FDA's case-specific waiting costs. I test the predictions of this theory using duration analyses of review times for 450 drugs reviewed from 1977 to 2000. In contrast to recent research on political control of the bureaucracy, drug approval times appear insensitive to shifts in the partisanship or ideology of congressional majorities, oversight committees, and presidents. Controlling for numerous clinical factors, FDA review times are decreasing in (1) the wealth of the richest organization representing the disease treated by the drug, (2) media coverage given to this disease, and (3) a nonlinear function of the number of groups representing this disease. Political influence over drug approval operates primarily through "salience signals" transmitted by groups and the media.

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