PDUFA IV: Changes to Implement and Challenges to Meet

FY 2008 PDUFA Performance Report Table of Contents

Reauthorized as Title I of FDAAA, PDUFA IV continues to provide funding for existing PDUFA performance goals and initiatives, while also expanding user fee funding to cover postmarket safety activities. FDA has committed to achieve PDUFA performance goals that apply to the review of original and resubmitted new product applications and efficacy and manufacturing supplements. FDA has also committed to achieve certain procedural and processing goals aimed at facilitating and assuring quality in new drug development. However, the changes and challenges that FDA faces in PDUFA IV as a result of the expansion of FDA’s responsibilities under FDAAA place unprecedented demands on FDA reviewer workloads. These added responsibilities can also have unintended and unexpected impacts on FDA’s short-term abilities to meet PDUFA IV goals.

• Continuation of Progress. PDUFA IV continues to provide funding for previously established PDUFA performance goals and initiatives. The first year of activity under PDUFA IV began on October 1, 2007, and ended on September 30, 2008. Preliminary performance results for FY 2008, the first year under PDUFA IV, are included in this report.
• New Goals and Initiatives to Ensure Strong Premarket Review and Postmarket Safety. FDAAA expanded requirements under the reauthorized Pediatric Research Equity Act (Title IV) and the Best Pharmaceuticals for Children Act (Title V). In addition, FDAAA Title IX gave FDA substantially expanded responsibilities and authorities regarding the postmarket safety of drugs. For example, FDA can now implement risk evaluation and mitigation strategies for approved drug products, require sponsors to conduct postmarket studies and clinical trials, and require safety labeling changes to address new safety information for marketed drugs. FDA is also tasked with developing systems capable of performing active postmarket risk identification and analysis. These new provisions greatly strengthen FDA’s ability to perform its mission of ensuring the availability of safe and effective drugs, but they also place increasing workload demands on FDA. The added responsibilities of FDAAA Titles IV, V and IX pertaining to new drugs are now part of the process for the review of human drugs.
• Staff Growth and Training. FDA made great strides in FY 2008 to increase the number of staff and begin to implement the provisions of FDAAA. A significant number of new staff have been hired; however, the influx of new reviewers creates a short-term drain on experienced reviewers’ and managers’ time as they work to train and mentor these new staff. In FY 2009, FDA will focus on further training and integrating the new staff into the review process and continuing to develop, implement, and streamline the processes and policies required by FDAAA, while maintaining a high level of performance and efficiency of core review work.
• Adapting to FDAAA. The changes and challenges presented by FDAAA resulted in unprecedented and unplanned demands on the workload of FDA staff (see table below). During FY 2008, the first year under PDUFA IV, FDA staff were still reviewing almost half of FY 2007 submissions. Most of these reviews were of 6-month and 10-month goals that were submitted in the second half of FY 2007. FDA reviewers also began to receive for review FY 2008 submissions. Additional resources were needed for PDUFA IV management and information technology initiatives. As referenced above, the hiring of a significant number of new staff came with the associated need for training and mentoring that can take up to 2 years before the new reviewers are able to conduct reviews independently.

NDAs and BLAs Filed

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