How does FDA determine fees?
For FY 1998 through 2002, under the PDUFA II, the human drug application fee rates are set in the statute, but are to be adjusted annually for cumulative inflation since FY 1997. Total application fees revenues are structured to increase or decrease each year as the number of applications submitted to FDA increases or decreases. For additional information, see the Federal Register notice of January 6, 2002, “Establishment of Prescription Drug User Fee Rates for Fiscal Year 2002” at http://www.fda.gov/OHRMS/DOCKETS/98fr/011602a.htm For FY 2003 through 2007, under PDUFA III, the fee revenue amounts are set in the statute and are adjusted annually for cumulative inflation after FY 2003. After adjustment for inflation, the revenues are also adjusted annually to reflect changes in the workload for the process for the review of human drug applications. For additional information, see the Federal Register notice establishing Prescription Drug User Fee Rates for Fiscal Year 2003 at http://www.
