PDUFA IV Five Year Financial Plan (2008): Purpose
This document is a financial blueprint for investing the $2.75 billion the agency expects to collect over the 5 fiscal years (2008 through 2012) under the recently reauthorized Prescription Drug User Fee Act, referred to as PDUFA IV. It provides FDA’s initial estimates of the revenues, allocations, and expenditures anticipated over the five-year period.
The plan seeks to ensure that fee revenues will be effectively used to meet the challenging goals associated with PDUFA IV. It proposes an initial allocation of the resources expected each year among the FDA components responsible for achieving PDUFA goals, to assure timely resource availability. The plan keeps faith with the agreements made prior to the recent reauthorization of PDUFA by planning expenditures in the same categories that were used during discussions that preceded reauthorization. Those categories are:
- PDUFA IV Fee Base –resources to continue to meet the challenging drug review timelines in effect at the end of FY 2007 over each of the next 5 years
- Increased Critical Path Efforts
- Increased Drug Safety Capacity
- Enhanced Information Technology Capabilities
- Additional Capabilities Added for Drug Safety by Congress
Resources for the PDUFA IV fee base are essential to assure the agency’s ability to continue to meet the challenging PDUFA III review goals that FDA is committed to continue to meet over the 5 years of PDUFA IV. The additional bulleted items represent distinct enhancements added under PDUFA IV.
FDA may update the plan, if necessary, to reflect significant changes in workload and replace revenue and expenditure estimates with amounts actually received and spent. Updates, if made, will also reflect any unanticipated contingencies that may occur. As was done over the past five years, FDA will make the plan, and any subsequent updates, publicly available for anyone to review and comment on.