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Regulating the Regulators: Whether User Fees for Prescription Drug Reviews within the FDA Approval Process are a Cause for Concern

Undergraduate Thesis
Nicolas Peña Brown

This paper studied the potential adverse impact of the Prescription Drug User Fee Act (PDUFA) on the integrity of the U.S. Food and Drug Administration (FDA) drug application review process. The concern was that PDUFA-established user fees could result in agency capture by the pharmaceutical drug industry. To determine the validity of this concern, the paper analyzed public data detailing the submission date of a new drug application and the subsequent date of approval. The data was then used to calculate the average drug review time for each manufacturer and establish whether those with more total user fee contributions experienced quicker review times. External factors were controlled for given a variety of confounding variables. If the firms were found to receive preferential treatment for greater user fee contributions to the FDA, it would be a sign of potential agency capture. Although a great deal more research is needed to verify the results, the analysis suggested that there is little, if any, association between the cumulative fees paid by a sponsor and the review times of its new drug applications. These findings may be good news for the FDA and other agencies who charge, or may want to charge, user fees to supplement their funding.