Up, Up and Away! FDA Sets Fiscal Year 2011 User Fee Rates

By Kurt R. Karst –   

In a Federal Register notice scheduled for publication on August 4th, FDA will announce the Prescription Drug User Fee Act (“PDUFA”) user fee rates for Fiscal Year (“FY”) 2011.  As in all previous years under the fourth iteration of PDUFA, the rates for all three types of user fees – application, establishment, and product – will rise.  Earlier this week, FDA announced the FY 2011 user fee rates for animal drugs, animal generic drugs, and medical devices.  Missing from the litany of products subject to user fees are generic human drugs.  We understand that negotiations for generic human drug user fees are slowly moving forward, and that there is a growing sentiment that legislation will be enacted next year. 

The FY 2011 PDUFA application user fee rates have been set at $1,542,000 for an application requiring “clinical data,” and one-half of a full application fee ($771,000) 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 $497,200 and $86,520, respectively.  The FY 2011 fees go into effect on October 1, 2010.

Although the FY 2011 application fee increased by $136,500, the 9.7% change from FY 2010 is less than the 12.7% jump between the FY 2009 and FY 2010 application rates.  The first table below shows the percent increase since the previous FY for each of the four FYs under PDUFA IV (for each fee type), and should be used with the table from our previous post, which tracks PDUFA user fees since the inception of PDUFA.  The next three tables show the historical trend for each PDUFA user fee. 

The increases in user fee rates, although not unexpected, are sure to boil the blood of some in the industry given FDA’s less than stellar performance record – see our previous post A Not So Sweet 16 for FDA and PDUFA!