Executive Summary

In 1992, Congress enacted the Prescription Drug User Fee Act (PDUFA). PDUFA provided FDA with additional resources to hire more medical and scientific reviewers to conduct premarket reviews as well as support staff and field investigators to speed up the application review process for human drug and biological products. In 1997, after a successful first five years, Congress reauthorized the program for five additional years (PDFUA II). Last year, Congress again extended PDUFA for five more years (PDUFA III). Each reauthorization has brought higher expectations for reviews and additional goals intended to improve FDA's responsiveness to and communication with industry sponsors. As a result of PDUFA, FDA has significantly reduced the review and approval times for new drug and biologic applications without compromising FDA's traditionally high standards for approval of new drugs and biologics.

All of the original applications submitted during FY 2001 have been reviewed and acted upon, and final performance data can now be reported. Only a preliminary performance assessment on applications submitted during FY 2002 is possible at this time. FDA exceeded all the review performance goals for original and resubmitted new drug and biological applications and for standard efficacy supplements and manufacturing supplements submitted in FY 2001. With regard to priority efficacy supplements submitted in FY 2001, FDA failed to meet the review goal for one of nine supplements, and thus failed to meet the 90 percent on time performance goal. Although it is too early to report final results, the Agency appears to be meeting or exceeding all the application review goals for FY 2002 submissions. In FY 2002, the Agency met or exceeded three of the six "procedural and processing" goals designed to improve its responsiveness to sponsor requests during the early phases of drug development.

Notwithstanding the successes noted above, the Agency encountered significant challenges in trying to meet the PDUFA II goals. The revenue the Agency collected from fees during PDUFA II was significantly less than expected due to a reduction in the number of new drug and biologic applications submitted and an increase in the proportion of applications that met the criteria for fee waivers. This decrease in resources combined with a continuing increase in overall workload under PDUFA resulted in significant stress to the program during the last few years of PDUFA II. The recently reauthorized PDUFA III aims to correct the balance between resources and workload over the first several years of the program, while further challenging the Agency with additional performance commitments.

Through all these reauthorizations, the goal of PDUFA has remained unchanged. The industry and FDA, working together, are bringing safe and effective new medicines to American patients and practitioners quickly without compromising FDA's traditionally high standards for safety, effectiveness, and product quality.

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