Improving Time to Pharmaceutical Approval: An Analysis of the Prescription Drug User Fee Act Process
- PDF / 143,191 Bytes
- 8 Pages / 602.986 x 782.986 pts Page_size
- 52 Downloads / 163 Views
Improving Time to Pharmaceutical Approval: An Analysis of the Prescription Drug User Fee Act Process
Drug Information Journal 46(1) 35-42 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861511429262 http://dij.sagepub.com
Andrea C. Masciale, JD1, Patricia L. DeSantis1, and Jay P. Siegel, MD2
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. Keywords PDUFA, review process, time to approval, advisory committee, REMS
Introduction The Prescription Drug User Fee Act of 1992 (PDUFA) and its subsequent reauthorizations establish pharmaceutical review performance goals for the US Food and Drug Administration (FDA) and authorize the agency to collect user fees in conjunction with pharmaceutical marketing applications. In the 2 decades since PDUFA was originally enacted, the program has been successful in enhancing timely access to new drug and biologic therapies and strengthening the agency’s pharmaceutical review and safety programs. The PDUFA program has been reauthorized 3 times since the initial legislation: in 1997 (PDUFA II) in conjunction with the Food and Drug Administration Modernization Act, in 2002 (PDUFA III) as part of the Bioterrorism Preparedness and Response Act, and in 2007 (PDUFA IV) with the Food and Drug Administration Amendments Act (FDAAA). The FDAAA was signed by President Bush on September 27, 2007, and became operative on October 1 of that year. With each reauthorization, as with the initial statute, industry group representatives have met with FDA management to discuss the process and agree on potential improvements and new fees to propose for congressional authorization.
More recently, other stakeholders have become more formally involved as well. PDUFA IV is set to expire on September 30, 2012, and members of
Data Loading...
