Back to Table of Contents: FY 2009 PDUFA Financial Report
Enacted in 1992, PDUFA authorized FDA to collect fees from the pharmaceutical industry to be spent on drug review, in addition to minimum amounts that must continue to be spent from appropriations. FDA used these additional resources to hire and support additional staff for the review of human drug applications, so that safe and effective drug products would reach the American public more quickly. PDUFA was a very successful program. With the support of the pharmaceutical industry, other stakeholders, and the Administration, Congress amended and extended PDUFA in 1997 (PDUFA II), 2002 (PDUFA III) and 2007 (PDUFA IV).
Under PDUFA IV, application fees, establishment fees, and product fees each contribute one-third of the total fee revenues in a fiscal year. An application fee must be submitted when certain New Drug Applications (NDAs) or Biologic License Applications (BLAs) are submitted. Product and establishment fees are due annually on October 1. The total annual fee revenue amounts set in statute for PDUFA IV, after a base workload adjustment, must be adjusted for annual changes in drug review workload for cumulative inflation since FY 2008. PDUFA IV authorizes FDA to set user fees in each fiscal year, so that the total revenue that FDA receives from each fee category (application fees, product fees, and establishment fees) approximates one-third of the estimated revenue amount after adjustments for workload and inflation.
PDUFA IV also requires FDA to submit two reports to Congress each fiscal year. A performance report is to be sent within 60 days after the end of a fiscal year, and a financial report is to be sent within 120 days. The FY 2009 PDUFA Performance Report, which discusses FDA’s progress in meeting the goals set for FDA in PDUFA IV, is being transmitted separately to Congress. This report is FDA’s FY 2009 PDUFA Financial Report, covering the period from October 1, 2008 to September 30, 2009.
As required by the statute, this report presents the legal conditions that must be satisfied before FDA can collect and spend the fees, and the calculations on how these conditions were met in FY 2009. This report also presents summary statements of FY 2009, earned revenue by fee source, and fee obligations by expense category. Finally, this report also presents the total costs in FY 2009, from both fee revenues and appropriations, of the process for the review of human drug applications, as defined in PDUFA.