This document is a blueprint for investing the substantial resources the agency expects to collect under the recently reauthorized Prescription Drug User Fee Act, referred to as PDUFA III. It provides FDA’s initial estimates of the revenues and expenditures anticipated over the five-year period of the most recent PDUFA reauthorization, fiscal years 2003 through 2007.
The plan seeks to ensure that fee revenues would be effectively used to meet the challenging goals associated with PDUFA III. It proposes an initial allocation of the resources expected each year among the FDA components responsible for achieving PDUFA goals. The plan keeps faith with the agreements made prior to the recent reauthorization of PDUFA by planning expenditures in the same nine categories that were used during discussions that preceded reauthorization. Those categories are:
- Meeting PDUFA II goals - the PDUFA II Additive Base
- Enhanced Training and Staffing
- Risk Management
- Electronic Submissions
- Continuous Marketing Applications
- Efficacy Supplement Resubmissions
- First Cycle Reviews
- Expert Outside Consultants
- Performance Management
In the discussions that preceded the enactment of PDUFA III, the first two bulleted items above were collectively referred to as “Sound Financial Footing” for the drug review program. FDA stressed that resources for these items were necessary to assure the agency’s ability to continue to meet the old PDUFA II goals in future years. The remaining bulleted items represent distinct new or enhanced goals under PDUFA III.
FDA will update the plan annually to reflect changes in workload and replace revenue and expenditure estimates with amounts actually received and spent. Updates will also respond to any unanticipated contingencies that may occur. As was done over the past five years, FDA will make the plan, and subsequent updates, publicly available for anyone to review and comment on.