PDUFA II Five-Year Plan -FY 2001 Update (April 2001)
1998 - 1999 - 2000 - 2001 - 2002
Department of Health and Human Services
FOOD AND DRUG ADMINISTRATION
Office of Management and Systems
The Prescription Drug User Fee Act of 1992 (PDUFA I) provided additional resources that enabled FDA to accelerate its drug evaluation process without compromising review quality. The Food and Drug Administration Modernization Act (FDAMA) of 1997 amended PDUFA and extended it through September 30, 2002 (PDUFA II). PDUFA II commits FDA to even faster review goals for some applications, new goals for meetings and dispute resolution, and the electronic receipt and review of applications by the end of FY 2002.
In July 1998, FDA completed the original PDUFA II Five-Year Plan. It was FDA’s blueprint for investing the resources expected under PDUFA II. It was based on the planning efforts of the three FDA components directly responsible for meeting these goals: (1) the Center for Drug Evaluation and Research (CDER), (2) the Center for Biologics Evaluation and Research (CBER), and (3) the Office of Regulatory Affairs (ORA). This is the third annual update.
The Secretary’s transmittal letter for our FY 2000 financial report recently stated that one of the biggest concerns FDA faces is the erosion of core resources. This has been caused by both (1) PDUFA requirements to increase spending on drug review from appropriations each year and (2) the fact that the agency has repeatedly not been given increased appropriations to cover the cost of pay and other cost increases. This is being addressed with the submission of President Bush’s FY 2002 budget. This plan assumes future funding to cover pay increases.
The changes to this update are minor compared with last year’s revisions. Total staffing will increase by 365 FTE’s for the centers and ORA by FY 2002. These are increases over FY 1997 staffing levels at the end of PDUFA I. Increases from 1997 staffing levels by component follow:
- CDER - an increase of 280 FTE’s by the end of 5 years (compared with an increase of 240 FTE’s in the original plan and an increase of 234 in last year’s update);
- CBER - a net increase of 85 FTE’s by the end of 5 years (compared with an increase of 57 FTE’s in the original plan and an increase of 79 in last years update); and
- ORA - level staffing by the end of 5 years (compared with an increase of 28 FTE’s in the original plan, and level staffing in last year’s update).
Revenues are re-estimated at about $5 million less than in last year’s update. Staffing increases are possible, even though revenues are reduced, because FDA will spend all of the money it collects each year, plus about $36 million of carry-over balances, in the final two years of PDUFA II. Increased spending is essential to meet the PDUFA II goals that become increasingly difficult in the final 2 years of PDUFA II. However, carryover balances by the end of FY 2002 are now estimated at less than $22 million. This low level of carryover funds at the end of FY 2002 make it imperative that PDUFA be reauthorized before September 30, 2002, to avoid a funding hiatus if PDUFA II expires before reauthorization is enacted.
Of the total planned spending, 59 percent will be allocated for employee salary and benefit costs. Center and ORA operating funds and IT investments will each use 12%. Of the total, CDER will spend 58%, CBER will spend 21%, and ORA will spend 6%. Overhead will use 8% of the funds, centrally funded items will use 5%, and rent payments to GSA will use 3%.
Operating at these levels should enable the agency to meet PDUFA goals through FY 2002.
Purpose - PDUFA II - FY 2001 Update (April 2001) Background - PDUFA I - FY 2001 Update (April 2001) Background - PDUFA II - FY 2001 Update (April 2001) Background - PDUFA II Goals - FY 2001 Update (April 2001) Background - FY 2001 Update (April 2001) Assumption - The increased staffing and support funded by PDUFA I will be maintained over the course of PDUFA II Assumption - Fee revenue estimates are based on annual increases of about 5 percent in fee-paying applications and a 3.7 percent in inflation Assumption - In each of the next 2 years, FDA will spend substantially more than it collects in fees, utilizing carryover balances available from previous years Assumption - About $247 million in new fee revenue will be available over 5 years Assumption - As in the original plan, it is assumed that all statutory conditions or "triggers" necessary for PDUFA to operate will be met each year Assumption- Funds planned for acquiring human resources may be spent on either hiring or contracting Assumption - The amount FDA pays for rent for PDUFA is no longer capped and increases must be paid from fees Assumption - No amount will be held in a contingency reserve for FY 2002 Assumption - By the end of PDUFA II, total spending from all sources for the human drug application review process will have increased by about 46 percent Assumption - The plan will be reassessed and updated annually Planning Process - FY 2001 Update (April 2001) CDER Plan Summary - FY 2001 Update (April 2001) CDER Plan Summary Tables - FY 2001 Update (April 2001) CBER Plan Summary - FY 2001 Update (April 2001) CBER Plan Summary Tables - FY 2001 Update (April 2001) ORA Plan Summary - FY 2001 Update (April 2001) ORA Plan Summary Tables - FY 2001 Update (April 2001) Overhead Summary - FY 2001 Update (April 2001) FDA Plan Summary - FY 2001 Update (April 2001) FDA Plan Summary Tables - FY 2001 Update (April 2001) Annual Reassessments - FY 2001 Update (April 2001) PDUFA II Fee and Revenue Estimation Worksheet