FDA Sets FY2009 User Fee Rates; Only a Modest Increase in PDUFA Fees Compared to FY2008

On August 1, 2008, FDA will publish a Federal Register notice announcing the Fiscal Year (“FY”) 2009 user fee rates established under the Prescription Drug User Fee Act (“PDUFA”).  A similar notice will also be issued with the FY 2009 user fee rates established under the Medical Device User Fee Amendments.

The FY2009 PDUFA application user fee rates have been set at $1,247,200 for an application requiring clinical data, and one-half of a full application fee ($623,600) for an application not requiring clinical data and a supplement requiring clinical data.  (An FDA guidance document defines the term “clinical data” for PDUFA user fee purposes.)  Annual establishment and product fees have been set at $425,600 and $71,520, respectively.  The FY2009 fees, which go into effect on October 1, 2008, are only a modest increase from those set for FY2008.  The table below tracks PDUFA user fees since the inception of PDUFA. 

FY	Rate	$ Difference & % Change From Previous FY
1993 (PDUFA I)
Application	$100,000	NA
Establishment	$60,000	NA
Product	$6,000	NA
1994
Application	$162,000	$62,000 (62%)
Establishment	$93,800	$33,800 (56.3%)
Product	$9,400	$3,400 (56.7%)
1995
Application	$208,000	$46,000 (28.4%)
Establishment	$129,000	$35,200 (37.5%)
Product	$12,200	$2,800 (29.8%)
1996
Application	$204,000	-$4,000 (1.9%)
Establishment	$135,300	$6,300(4.9%)
Product	$12,600	$400(3.3%)
1997
Application	$205,000	$1,000 (0.5%)
Establishment	$115,700	-$19,600 (-14.5%)
Product	$13,200	$600 (4.8%)
1998 (PDUFA II)
Application	$256,846	$51,846 (25.3%)
Establishment	$141,966	$126,266 (22.7%)
Product	$18,591	$5,391 (40.8%)
1999
Application	$272,282	$15,436 (6.0%)
Establishment	$128,435	-$13,531 (-9.5%)
Product	$18,364	-$227 (-1.2%)
2000
Application	$285,740	$13,458 (4.9%)
Establishment	$141,971	$13,536 (10.5%)
Product	$19,959	$1,595 (8.7%)
2001
Application	$309,647	$23,907 (8.4%)
Establishment	$145,989	$4,018 (2.8%)
Product	$21,892	$1,933 (10.1%)
2002
Application	$313,320	$3,673 (1.2%)
Establishment	$140,109	-$5,880 (-4.0%)
Product	$21,630	$262 (-1.2%)
2003 (PDUFA III)
Application	$533,400	$220,080 (70.2%)
Establishment	$209,900	$69,791 (49.8%)
Product	$32,400	$10,770 (49.8%)
2004
Application	$573,500	$40,100 (7.5%)
Establishment	$226,800	$16,900 (8.1%)
Product	$36,080	$3,680 (11.4%)
2005
Application	$672,000	$98,500 (17.2%)
Establishment	$262,200	$35,400 (15.6%)
Product	$41,710	$5,630 (15.6%)
2006
Application	$767,400	$95,400 (14.2%)
Establishment	$264,000	$1,800 (0.7%)
Product	$42,130	$420 (1.0%)
2007
Application	$896,200	$128,800 (16.8%)
Establishment	$313,100	$49,100 (18.6%)
Product	$49,750	$7,620 (18.1%)
2008 (PDUFA IV)
Application	$1,178,000	$281,800 (31.4%)
Establishment	$392,700	$79,600 (25.4%)
Product	$65,030	$15,280 (30.7%)
2009
Application	$1,247,200	$69,200 (5.9%)
Establishment	$425,600	$32,900 (8.4%)
Product	$71,520	$6,490 (10.0%)

By Kurt R. Karst