Executive Summary PDUFA FY 2008

FY 2008 PDUFA Performance Report Table of Contents

The passage of FDAAA began FDA’s transition into PDUFA IV during FY 2008 with the expansion of user fee funding to cover postmarket safety activities. FDAAA also 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. As a result of these changes, FDA faced unprecedented challenges in FY 2008 as it began to assess and enact new requirements while addressing PDUFA review commitments.

This report presents FDA’s performance in meeting annual PDUFA review goals for FY 2007 and FY 2008, with both years being impacted by the PDUFA IV transition. Review performance for submissions received in FY 2007, and initially reported in the FY 2007 report, is updated and finalized. FDA’s preliminary progress in meeting review performance goals for submissions received in FY 2008, and procedural and processing goals for FY 2008, are also covered in this report. Additionally, this report describes FDA’s transition into PDUFA IV and progress in accomplishing management initiatives and in meeting the information technology commitments of PDUFA IV.

Review workload varied in FY 2008; this again demonstrated the difficulty in predicting how many submissions and corresponding reviews would be needed in any given category. Overall submissions were down by over 3 percent when compared to the previous 5 years; however, original NDAs and BLAs filed were up 20 percent compared to the same time period. FDA began FY 2008 with 1,441 submissions carried over for review from FY 2007, including 95 original NDAs and BLAs. FDA ended FY 2008 with 1,101 submissions pending and not overdue, including 106 original NDAs and BLAs.

Because review performance in any given year impacts prior year performance goals as well as current year performance goals, final FY 2007 performance goals and preliminary FY 2008 performance goals showed mixed results. As of September 30, 2008, FDA completed review on virtually all (3,089 of 3,096) FY 2007 submissions. FDA can now report that it met or exceeded half (6 of 12) of PDUFA 2007 performance goals:

• priority NDAs and BLAs, including priority new molecular entities (NMEs) and BLAs;
• resubmitted Class 2 NDAs and BLAs;
• Class 2 resubmitted efficacy supplements; and
• manufacturing supplements requiring prior approval along with manufacturing supplements not requiring prior approval.

FDA was meeting or exceeding half of FY 2008 performance goals as of the end of FY 2008. However, with improved performance in FY 2009, FDA has the potential to meet or exceed up to three-quarters (9 of 12) of performance goals for FY 2008:

• standard NDAs and BLAs, including standard NMEs and BLAs;
• resubmitted Class 1 NDAs and BLAs;
• priority and standard efficacy supplements;
• Class 1 and Class 2 resubmitted efficacy supplements; and manufacturing supplements requiring prior approval along with manufacturing supplements not requiring prior approval.

Workload related to the meeting management procedural and processing goals generally declined in FY 2008, and only the number of responses to clinical holds experienced an increase. However, FDA did not meet any FY 2008 procedural and processing goals.

This report also describes FDA’s transition into PDUFA IV and progress in accomplishing management initiatives under, and in meeting the information technology commitments of, PDUFA IV.

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