FDA,FY 2000 Performance Report for the Prescription Drug User Fee Act of 1992,Efficacy Supplements

Report on PDUFA Goals: Efficacy Supplements

Goal: Review and act upon complete efficacy supplements to NDAs and BLAs

The table below summarizes the annually decreasing review-time goals for efficacy supplements to NDAs and BLAs under PDUFA ii. Review goals for efficacy supplements follow the same progression as the review goals for original NDAs and BLAs. Over the five-year period, the goal of reviewing 90 percent of priority efficacy supplements in six months remains constant. For standard efficacy supplements, the review-time goals drop over the five-year period. For FY 98 submissions, the goal was to review 90 percent in 12 months; for FY 02 submissions, the goal is to review 90 percent in 10 months. For standard efficacy supplements received in FY 2000, the goal was to review 90 percent in 12 months and 50 percent in 10 months.

Goals		On-Time Performance by Submission Year
Goals		FY 98	FY 99	FY 00	FY 01	FY 02
Priority	6 months	90% on time	90%	90%	90%	90%
Standard	12 months 10 months	90%	90% 30%	90% 50%	90% 70%	90%

Workload

Workload -- Efficacy supplements filed (Priority / Standard):
	FY 96	FY 97	FY 98	FY 99	FY 00⁴
to NDAs	103	146 (10/136)	126 (10/116)	135 (15/120)	173 (16/157)
to BLAs	8	15 (3/12)	10 (1/9)	10 (2/8)	11 (2/9)
PDUFA total	111	161 (13/148)	136 (11/125)	145 (17/128)	184 (18/166)

Performance:

FY 99 Submissions:

Fifteen of the seventeen priority efficacy supplements submitted in FY 99 were reviewed and acted upon within the 6 month review goal. The on-time rate of 88 percent narrowly missed the 90 percent on-time goal.

All of the standard efficacy supplements were reviewed and acted upon within 12 months and 86 percent were reviewed within 10 months. This performance exceeds the FY 99 goals of 90 percent and 30 percent respectively.

FY 99 Submissions		Reviewed and acted upon	Number on time	Percent on time
Priority	6 months	17	15	88
Standard	12 months 10 months	128	128 110	100 86

FY 00 Submissions:

Fifteen of the eighteen priority efficacy supplements submitted in FY 00 have been reviewed and acted upon. All have met the 6-month review goal. Only 33 of the 166 standard efficacy supplements have been reviewed, but all of these have met the 10-month goal.

FY 00 Submissions		Reviewed and acted upon	Number on time	Percent on time
Priority	6 months	15	15	100
Standard	12 months 10 months	33	33 33	100 100