FY 2010 User Fees Released

The US Food and Drug Administration announced its prescription drug user fee rates for fiscal year (FY) 2010 in the August 3 Federal Register. Each year, one-third of fees generated from the Prescription Drug User Fee Amendments of 2007 (PDUFA IV) come from fees for applications, establishments, and products, according to the announcement.

The FY 2010 fees for applications requiring clinical data will be set at $1,405,500; applications that do not require clinical data or supplemental clinical data will be $702,750. FDA estimates that 25% of applications submitted each year arrive at the agency during the last three months of the year.

Establishment fees for FY 2010 will be set at $457,200. FDA estimates that 450 establishments have been billed for FY 2009 fees and that, of those 450, 20 waivers or exceptions will be made before the end of FY 2009, on Sept. 30. In addition, another 15 exemptions will be made for orphan drug fees.

Product fees for FY 2010 will be set at $77,720. FDA estimates that in FY2009, 2450 products will have been billed for fees. Of those, the agency expects to grant about 50 waivers and reductions by Sept. 30, 2009. Another 20 product fees will be exempted before the end of FY 2009 for orphan drug qualifications.

Below is a comparison of the year over year fee increases:

The total fee revenue amount for FY 2010 is $569,207,000. All fees are effective Oct 1, 2009.