PDUFA, as amended, contains three legal conditions or "triggers" that must be satisfied each year before FDA can collect and spend user fees. As an example, the following calculations summarize how those conditions were met for FY 1999.
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 1999, FDA's Salaries and Expenses Appropriation (excluding user fees and excluding rent to GSA, which was also not included in the FY 1997 Appropriated amount) totaled $888,001,000. FDA's FY 1997 total Salaries and Expenses appropriation, excluding user fees, and adjusted as required by the statute, was $831,743,368. Therefore, since the FY 1999 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 1999 FDA's appropriation acts specified that $132,273,000 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 1999 the adjustment factor is just under 1.0144, making the adjusted amount $150,083,954. As this report shows, in FY 1999 FDA used $159,669,575 from appropriated funds for the drug review process, which exceeds the specified minimum amount. Thus, the third condition was met.
Edited 3/2/2000