FDA,FY 2001 Performance Report for the Prescription Drug User Fee Act of 1992,Efficacy Supplements

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 2001, the goal was to review 90 percent in 12 months and 70 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 97	FY 98	FY 99	FY 00	FY 01⁴
to NDAs	146 (10/136)	126 (10/116)	135 (15/120)	175 (18/157)	152 (7/145)
to BLAs	15 (3/12)	10 (1/9)	10 (2/8)	12 (2/10)	16 (2/14)
PDUFA total	161 (13/148)	136 (11/125)	145 (17/128)	187 (20/167)	168 (9/159)

Performance

All 20 of the priority efficacy supplements submitted in FY 2000 were reviewed and acted upon within the 6 month review goal. On-time performance was 100 percent which exceeded the 90 percent goal.

All but one of the standard efficacy supplements were reviewed and acted upon within 12 months and 91 percent were reviewed within 10 months. This performance exceeds the FY 2000 goals of 90 percent and 50 percent respectively.

FY 00 Submissions		Reviewed and acted upon	Number on time	Percent on time
Priority	6 months	20	20	100
Standard	12 months 10 months	167	166 152	99 91

Four of the nine priority efficacy supplements submitted in FY 2001 have been reviewed and acted upon. All have met the 6-month review goal. Only 19 of the 159 standard efficacy supplements have been reviewed. All of these have met the 10-month review goal.

FY 01 Submissions		Reviewed and acted upon	Number on time	Percent on time
Priority	6 months	4	4	100
Standard	12 months 10 months	Too early to report meaningful review performance statistics. Nineteen standard efficacy supplements have been reviewed and acted upon, all within 10 months.

Report on PDUFA Goals: Efficacy Supplements

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

Workload

Performance