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FY 1998 PDUFA Financial Report: Meeting the Legal Conditions for User Fees in FY 1998

Table of Contents

Previous Section: Background

PDUFA, as amended, contains three legal conditions or "triggers" that must be satisfied each year before FDA can collect and spend user fees. FDA's calculations showing how those conditions were met for FY 1998 are presented in more detail in Appendix A. FDA did meet all necessary conditions in FY 1998, as summarized below.

The first condition is that FDA's Salaries and Expenses Appropriation (excluding user fees) must meet or exceed FDA's FY 1997 Salaries and Expenses Appropriation (excluding user fees and adjusted for inflation). In FY 1998, FDA's Salaries and Expenses Appropriation (excluding user fees) totaled $857,501,000. FDA's FY 1997 Salaries and Expenses Appropriation (excluding user fees, and adjusted for inflation as specified by statute) was $819,971,000. Therefore, since the FY 1998 amount is greater, the first condition was met.

The second condition is that the amount of user fees collected each year must be specifically included in FDA's appropriations. For FY 1998 FDA's appropriation acts specified that $117,122,000 would come from PDUFA fees, in addition to sums provided in regular appropriations. The appropriation act specified that the fees collected could remain available until expended. Thus, the second condition was met.

The third condition is that user fees may be collected and used only in years when FDA also uses a specified minimum amount of appropriated funds for the drug review process. The specified minimum is the amount FDA spent on the drug review process from appropriations (exclusive of user fees) in FY 1997, adjusted for inflation. That amount was $147,959,689, as reported in last year's financial statement, and for FY 1998 the adjustment factor is one. As this report shows, in FY 1998 FDA used $151,836,635 from appropriated funds for the drug review process, which exceeds the specified minimum amount. Thus, the third condition has been met.

Appendix A provides more detail on the calculations that support our assertion that these three statutory conditions were met

Next Section: User Fee Revenues