Improving Time to Pharmaceutical Approval: An Analysis of the Prescription Drug User Fee Act Process

Abstract

The Prescription Drug User Fee Act of 1992 (PDUFA) established pharmaceutical review performance goals and authorized the US Food and Drug Administration (FDA) to collect user fees in conjunction with pharmaceutical marketing applications. There have been 3 subsequent reauthorizations of PDUFA; the most recent, referred to as PDUFA IV, was enacted with the Food and Drug Administration Amendments Act of 2007. PDUFA IV is set to expire on September 30, 2012, and it is expected that another reauthorization (herein referred to as PDUFA V) will be enacted before PDUFA IV expires. Industry and FDA, with stakeholder input, have held technical discussions to develop and agree upon performance goals for PDUFA V, which are proposed for congressional consideration. The discussions took place amid concerns that drug approvals were taking longer under PDUFA IV than under previous PDUFA programs. This article presents an analysis of the FDA’s Center for Drug Evaluation and Research application approval data, assessing changes in time from submission to approval and identifying and addressing hypotheses regarding the causes of those changes. The analyses support the potential for the proposed goals and process changes in the PDUFA V agreement to lead to improvements in overall approval time.