FDA Sets FY2009 User Fee Rates; Only a Modest Increase in PDUFA Fees Compared to FY2008
July 31, 2008On 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%) |
Application | $256,846 | $51,846 (25.3%) |
Establishment | $141,966 | $126,266 (22.7%) |
Product | $18,591 | $5,391 (40.8%) |
Application | $272,282 | $15,436 (6.0%) |
Establishment | $128,435 | -$13,531 (-9.5%) |
Product | $18,364 | -$227 (-1.2%) |
Application | $285,740 | $13,458 (4.9%) |
Establishment | $141,971 | $13,536 (10.5%) |
Product | $19,959 | $1,595 (8.7%) |
Application | $309,647 | $23,907 (8.4%) |
Establishment | $145,989 | $4,018 (2.8%) |
Product | $21,892 | $1,933 (10.1%) |
Application | $313,320 | $3,673 (1.2%) |
Establishment | $140,109 | -$5,880 (-4.0%) |
Product | $21,630 | $262 (-1.2%) |
Application | $533,400 | $220,080 (70.2%) |
Establishment | $209,900 | $69,791 (49.8%) |
Product | $32,400 | $10,770 (49.8%) |
Application | $573,500 | $40,100 (7.5%) |
Establishment | $226,800 | $16,900 (8.1%) |
Product | $36,080 | $3,680 (11.4%) |
Application | $672,000 | $98,500 (17.2%) |
Establishment | $262,200 | $35,400 (15.6%) |
Product | $41,710 | $5,630 (15.6%) |
Application | $767,400 | $95,400 (14.2%) |
Establishment | $264,000 | $1,800 (0.7%) |
Product | $42,130 | $420 (1.0%) |
Application | $896,200 | $128,800 (16.8%) |
Establishment | $313,100 | $49,100 (18.6%) |
Product | $49,750 | $7,620 (18.1%) |
Application | $1,178,000 | $281,800 (31.4%) |
Establishment | $392,700 | $79,600 (25.4%) |
Product | $65,030 | $15,280 (30.7%) |
Application | $1,247,200 | $69,200 (5.9%) |
Establishment | $425,600 | $32,900 (8.4%) |
Product | $71,520 | $6,490 (10.0%) |