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Response: Examining the Determinants of Drug Review Times: Considering Alternative Approaches

Understanding the factors that influence the speed of new-drug approval is a subject of much interest and discussion. Dan Carpenter’s commentary on my article suggests some alternative approaches for examining this issue. These include the use of a broader set of drugs than was considered in my study and panel data duration methods to examine the effects of agency staff and user fees on drug review times. He finds a result that differs from mine regarding the impact of agency staff on drug approval times. I welcome the opportunity to respond to his commentary and provide some additional discussion of the differences in our approaches. However, I must disagree that staff increases alone are predominantly responsible for the large reduction in drug review times. I find that staff increases are associated with longer new molecular entity (NME) review times prior to the reform. Only after the reform is there a large reduction in NME review times. In this response, I consider the three key suggestions raised by Carpenter: (1) broadening the scope of new molecular entities studied, (2) using submission-year averaging, and (3) using duration analysis to estimate the impact of agency resources (in a drug’s submission year) on drug review times. I will critically assess each alternative. This assessment should help readers gain a better understanding of the statistical issues that arise in such research. I find that Carpenter’s approach is not well suited for isolating the effect of agency staff on drug review times. It may in fact confuse the effects of