FY 1999 PERFORMANCE REPORT
TO CONGRESS

for the

Prescription Drug User Fee
Act of 1992

as reauthorized and amended by the

Food and Drug Administration
Modernization Act of 1997

Food and Drug Administration
Department of Health and Human Services

This report was prepared by FDA's Office of Planning in collaboration with the
Center for Biologics Evaluation and Research (CBER) and the
Center for Drug Evaluation and Research (CDER).
To obtain a printed copy of this report, contact

Office of Planning (HFP-1)
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Phone: 301-827-5292
FAX: 301-827-5298

Executive Summary

FY 1999 marked the seventh year of statutorily specified performance under the original Prescription Drug User Fee Act (PDUFA) of 1992 and the second year under the expanded performance specifications set forth in the Food and Drug Administration Modernization Act (FDAMA) of 1997. The FY 99 performance requirements continued the multi-year progression toward ever shorter review time goals and added a number of new performance goals that required new tracking and management capabilities within FDA.

In FY 1999, FDA reviewed and acted upon a total of 2,111 PDUFA-related original and resubmitted new product applications, original efficacy supplements, and original manufacturing supplements. This workload increased more than 12 percent over the 1,899 PDUFA-related review decisions the Agency made in FY 1998. More than 98 percent of the decisions made in FY 1999 were within the prescribed PDUFA time frames.

In addition, FY 1999 posted the first year of FDA performance on a variety of new goals seeking to shorten the investigative phase of drug development. In FY 1999 FDA took action on a total of 4,062 goal-specific events relating to sponsor meetings and other drug development milestones. The vast majority of these actions had no performance goals prior to FY 1999.

Despite the increased workload, the more numerous goals, and the shorter target review times, the high level of performance that FDA has achieved under PDUFA continued in FY 1999.

 

TABLE OF CONTENTS

Outcomes

REPORT ON PDUFA GOALS

Original New Product Applications
Resubmitted New Product Applications
Efficacy Supplements
Manufacturing Supplements
Procedural and Processing Goals
Notes
Appendices:
Appendix A: Purpose
Appendix B: PDUFA II Performance Goals, FY 1998 - FY 2002
Appendix C: List of Approved Applications

Outcomes
The last two PDUFA Performance Reports identified several important outcomes that had resulted from the Agency’s meeting and exceeding its application review performance commitments. These included increasing numbers of applications filed, higher quality applications, and quicker approvals for products with the requisite data; outcomes that result in more quality products reaching American practitioners and consumers faster. While the Agency continues to exceed the review performance goals of PDUFA II1 even as the goals become more challenging each year, the dramatic gains of the early PDUFA years have slowed. Still, application filings and quality remain high by historic standards, and approval times continue to drop.
. percent applications approved High Approval Rates: The percentage of filed new product applications that ultimately are approved increased from the less than 60% rate of the pre-PDUFA years2 to roughly 80% for applications submitted from FY 93 through FY 95. These early PDUFA cohorts are essentially finished; no submissions from earlier than FY 96 were approved in FY 99. The approval rate for FY 96 new product applications currently stands at 88% and could reach 90% if the sponsors are able to submit adequate answers to noted deficiencies. For the FY 97 applications, 97 of 133 (73%) have been approved, and the final approval rate should be above 80% if present trends hold.
.median approval times Quick Approval Times: Approval time is the total time from the submission of a marketing application to the issuance of an approval letter for that application. It includes both FDA’s review time and the time the sponsor spends answering deficiencies noted by FDA. The median approval time was 12 months3 for new product applications submitted in FY 96, FY 97, and FY 98. Given the progression of PDUFA II review goals, median approval times may drop to 10 months in FY 2001 or FY 2002 if the current rate of first review cycle approvals is sustained.

Median approval times for priority applications submitted in FY 98 dropped to 6 months3, less than half the median approval times for priority applications submitted in the early PDUFA years. The products of priority applications represent significant therapeutic gains and are an important outcome for the consumer and the medical community.

clinical development time Shorter Drug Development Times: The time consumed by the clinical development phase of drug development has decreased by 18% in recent years. An independent study by the Tufts Center for the Study of Drug Development4 reports that new molecular entities approved from 1996-98 required an average of only 5.9 years of clinical research compared with 7.2 years for the preceding 1993-95 interval. This 15-month savings in overall drug development time coincides with the substantial PDUFA I increase in FDA/Sponsor interactions regarding the clinical trial process. Additional savings are expected in future years as the PDUFA II goals regarding FDA/Sponsor meetings are realized.
patient access time Comparative International Timeliness: The United States was, once again in 1999, the decisive leader in first world introductions of new pharmaceutical therapies. Direct comparison of the European Union’s (EU) regulatory approval system with FDA through the 1998 submission year demonstrates a sustained and significant U.S. patient availability advantage for new molecular entities of more than six months.

 
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