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PDUFA provides FDA more revenue to hire additional reviewers and support staff and upgrade its information technology systems to speed up the application review process for new drugs and biological products without compromising FDA's traditionally high standards for approval. Under PDUFA, FDA agreed to meet certain performance goals that apply to the review of original and resubmitted new product applications and efficacy and manufacturing supplements to approved applications. FDA also agreed to meet certain procedural and processing goals aimed at speeding up drug development.
During the first few years of PDUFA I, FDA eliminated backlogs of original applications and supplements that had formed in earlier years when the program had fewer resources. Over the course of PDUFA I, the Agency agreed to review and act on a progressively increasing proportion of original NDAs, BLAs, and efficacy supplements within 12 months and resubmissions and manufacturing supplements within 6 months. The Agency also agreed to review and act on 90 percent of priority NDAs, BLAs, and efficacy supplements (i.e., submissions for products providing significant therapeutic gains) submitted in FY 1997 within 6 months. Over the course of PDUFA I, FDA exceeded all of these performance goals.
In 1997, Congress passed the FDAMA and reauthorized PDUFA (PDUFA II) for five more years. Under PDUFA II, most review times were shortened and the Agency met or exceeded nearly all its review goals. PDUFA II also set new goals intended to improve communication between FDA and application sponsors during the drug development process. These goals specified time frames for scheduling meetings, responding to various sponsor submissions, such as special protocols and responses to clinical holds, and other activities.
In 2002, Congress passed the Bioterrorism Act, which included an extension of PDUFA (PDUFA III) for five more years, FY 2003 through FY 2007. PDUFA III review performance goals and the procedural and processing goals are largely the same as the PDUFA II FY 2002 performance levels for these goals. PDUFA III establishes several new initiatives to improve application submissions and agency-sponsor interactions during drug development and application review. In addition, it authorizes FDA to spend user fee funds on certain aspects of postmarket risk management. Details about PDUFA III, including the text of the amendments and the performance goals and procedures can be found at www.fda.gov/oc/pdufa/default.html.
PDUFA-enabled improvements in review efficiency and application quality have had an impact on the overall time to marketing approval. FDA tracks a variety of metrics related to the process of human drug review. The time-to-approval statistics are affected by a number of factors, including the total number of NDA and BLA submissions and the number of newly submitted priority applications, as well as the overall quality of submitted applications and the number of review staff relative to the review workload. These factors can vary from year to year; the charts that follow provide an update on trends in submissions and overall approval times.
Number of Applications and Priority Applications Increased in FY 2004. The total number of submitted and filed applications increased from 109 in FY 2003 to 137 in FY 2004, and the number of priority applications increased from 23 in FY 2003 to 25 in FY 2004. Priority applications represent significant therapeutic gains, and in FY 2004 they accounted for over 18 percent of the total application pool. FDA began to measure performance by priority and standard under PDUFA in FY 1997.
Median Time to Approval Decreased in FY 2003 for Priority Applications. Median approval times for original NDA and BLA priority applications decreased in FY 2002 to 9.0 months and preliminary estimates indicate that median approval times for FY 2003 priority applications have continued to decrease. Based on applications approved by September 30, 2004, and under the theory that 80 percent of all filed applications will eventually be approved, the estimated median approval time is 6.4 months for FY 2003. The median approval time for standard applications was 12.8 months in FY 2002 and is estimated to be 13.8 months in FY 2003.
Percentage of First Cycle Approvals for Priority Applications Increased in FY 2003. The percentage of priority applications that were approved on the first cycle increased in FY 2003. FDA approved 57 percent of priority applications as compared to 47 percent in FY 2002. The percentage of first cycle approvals for standard applications was 36 percent in FY 2002 and 35 percent in FY 2003. Longer times to marketing approval can usually be attributed to applications that require more than one review cycle. PDUFA III includes an initiative to identify the causes of multiple review cycles and to provide earlier feedback on major deficiencies to application sponsors.
