This report updates the Agencyís review performance on the FY 98 application submissions and evaluates its performance in reviewing FY 99 application submissions and meeting other PDUFA II goals. All but one of the FY 98 submissions have been reviewed and acted upon, and final performance relative to the goals can now be reported. Only a preliminary performance assessment on FY 99 submissions is possible at this time. For submission categories with a 10- or 12-month review goal, it is too early to measure review performance. For those submission categories with a review goal that is shorter than 10 months, performance on submissions received early in the fiscal year provides an early-indicator of final review performance. Unless otherwise noted, all performance data in this section are as of September 30, 1999.

This report continues the reporting conventions first described in the FY 1998 report:

Although many of the Agencyís performance goals under PDUFA II are new and have no parallels under PDUFA I, the goals relating directly to application review seek to extend and improve on the gains made under PDUFA I. This report continues to show both current performance and past performance relative to these review goals. The report shows performance for the last five years. 

CBER is in the process of changing from counting PLAs and ELAs separately to combining them as BLAs (Biologic License Applications). This report shows CBERís workload and performance on PLAs and BLAs only (i.e., Product Applications). To simplify notation, it uses BLA as a generic term for both BLAs and PLAs. Original and resubmitted ELAs have been dropped, both from workload counts and performance measurements. These new counts are reflected in the workload and performance data for the PDUFA I years, so trends into PDUFA II are consistent.

In earlier PDUFA Performance Reports, the "Workload" and "Performance" figures for NDAs excluded original new product applications that fell under the PDUFA definition of "human drug products" but which did not pay fees. Since these applications are subject to the same performance goals as the fee-paying applications, they are included in this report, both under "Workload" and in the "Performance" figures. Workload figures from earlier years have been adjusted to include these applications also.

Original New Product Applications

Goal--Review and act upon complete Original NDAs and BLAs⁵

On-time Goal		Submission Year
		FY 98	FY 99	FY 00	FY 01	FY 02
Priority	6 months	90%	90	90	90	90
Standard	12 months 10 months	90%	90 30	90 50	90 70	90

 

Workload -- Original submissions filed (Priority/Standard):
	FY 95		FY 96		FY 97			FY 98	FY 996
NDAs	109		106		117 (25/92)			108 (30/78)	121 (29/92)
BLAs	12		9		16 (3/13)			12 (8/4)	6 (1/5)
PDUFA Total	121		115		133 (28/105)			120 (38/82)	127 (30/97)
NMEs7								43 (19/24)	43 (16/27)

Performance  FY 98 Submissions: All 120 FY 98 submissions have been reviewed and acted upon, all on time.  FY 99 Submissions: All 26 (19 priority and 7 standard) FY 99 submissions that have been reviewed and acted upon were on time.  Early indicator performance for 18 priority (6-month goal) NDAs received during the first six months of FY 99 is 100 percent on time. No priority BLAs were received in the first 6 months.  NMEs and BLAs All 43 discrete NMEs (19 priority and 24 standard) and 12 BLAs (8 priority and 4 standard) submitted in FY 98 have been reviewed and acted upon, all on time. All 10 priority NMEs received in the first 6 months of FY 99 were reviewed and acted upon on time.

Goal -- Review and act upon resubmitted⁸ NDAs and BLAs⁵

Performance  FY 98 Resubmissions: 79 percent (19 of 24) of all Class 1 resubmissions were reviewed and acted upon within 2 months; all were reviewed and acted upon within 6 months.  All 46 of the Class 2 resubmissions were reviewed and acted upon within 6 months.  FY 99 Resubmissions: All 17 of the Class 1 resubmissions that have been reviewed and acted upon have met the 2-month review goal.  All 27 of the Class 2 resubmissions that have been reviewed and acted upon have met the 6-month review goal.  Early-indicator performance for 17 Class 1 resubmissions submitted in the first 10 months of FY 99 is 100% reviewed and acted upon within 2 months.  Early-indicator performance for 19 Class 2 resubmissions submitted in the first 6 months of FY 99 is 100% on time (i.e., within 6 months).