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Managing Delegation in the FDA: Reducing Delay in New-Drug Review

Abstract.

This article examines the effects of the user fee reform on the speed of drug review in the U.S. Food and Drug Administration. The results show that even after controlling for increased agency resources, the reform reduced review times among new-drug approvals by 34 percent (95 percent confidence interval, 11 to 51 percent, p = .01). The results suggest that increased agency resources alone cannot explain the reductions in drug-review times. Evidence suggests that other reform-specific factors facilitated the change. Such factors may include the agency's desire to obtain program renewal and secure future fee revenues as well as heightened industry monitoring. Additional results show that there were significant increases in the speed of review for novel drugs in the reform era and for drugs in certain classes that have historically experienced longer delays. The results suggest that the user fee reform has helped politicians manage delegation and reduce delay in new-drug review.

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