Explaining reductions in FDA drug review times: PDUFA matters.

Abstract

Yale professor Mary Olson responds to the paper titled "Approval Times for New Drugs: Does the Source of Funding for FDA Staff Matter?" by Daniel Carpenter and colleagues (Health Affairs Web Exclusive, 17 December 2003). According to her analysis, the Prescription Drug User Fee Act (PDUFA) of 1992, which introduced user fees for new-drug review, had a greater impact on reducing drug approval times than the analysis of Carpenter and colleagues found. Olson's analysis examined review times aggregated by year of approval, instead of the year that the drug application was submitted. She found that even after increased agency resources over time were controlled for, the user fee reform led to a substantial reduction in drug review times. She also found that there was little reduction in drug review times until after user fees were introduced.