FDA Sets Fiscal Year 2010 Drug and Device User Fees; Rate Increases for Most Fees

By Kurt R. Karst –      

Earlier this week FDA issued several Federal Register notices setting the Fiscal Year (“FY”) 2010 user fee rates for human drugs under the Prescription Drug User Fee Act (“PDUFA”), for medical devices under the Medical Device User Fee and Modernization Act (“MDUFMA”), and for animal drugs (here and here) under the Animal Drug User Fee Act (“ADUFA”) and Animal Generic Drug User Fee Act (“AGDUFA”). 

The FY10 PDUFA application user fee rates have been set at $1,405,500 for an application requiring “clinical data,” and one-half of a full application fee ($702,750) for an application not requiring “clinical data” and a supplement requiring “clinical data.”  (The term “clinical data” for PDUFA user fee purposes is explained in an FDA guidance document available here.)  Annual establishment and product fees have been set at $457,200 and $79,720, respectively.  The FY10 fees go into effect on October 1, 2009. 

While the FY10 increases in the establishment and product user fee rates are generally consistent with the jump between FY08 and FY09 rates, the increase in the application user fee rate is more significant – increasing 12.7% in FY10 over FY09, compared to a 5.9% increase in FY09 over FY08.  The table below shows the percent increase since the previous FY, and should be used with the table from our previous post, which tracks PDUFA user fees since the inception of PDUFA.

The FY10 MDUFMA user fee rates have also increased over FY09.  For example the standard Premarket Application fee, which was $200,725 in FY09, is now $217,787 – an 8.5% increase.  The standard 510(k) user fee is $4,007 for FY10, which is also an 8.5% increase over the $3,693 FY09 fee.

For FY10, the animal drug user fee rates under ADUFA are $290,400 for an animal drug application, $145,200 for a supplemental animal drug application for which safety or effectiveness data are required, $6,185 for an annual product fee, $73,850 for an annual establishment fee, and $57,100 for an annual sponsor fee.  This compares to FY09 when the fees were $246,300, $123,150, $4,925, $59,450, and $52,700, respectively. 

The FY10 fees under AGDUFA are $75,000 per application for an abbreviated generic new animal drug application for which safety or effectiveness data are required, a $3,255 annual product fee, and an annual sponsor fee (that is lower than FY09) of $54,050 for each generic new animal drug sponsor paying 100% of the sponsor fee, $40,537 for each generic new animal drug sponsor paying 75% of the sponsor fee, and $27,025 for a generic new animal drug sponsor paying 50% of the sponsor fee.  This compares to FY09 when the fees were $41,400, $3,005, $56,350, $42,265, and $28,175, respectively.