FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

FDA's BUDGET PROPOSAL FOR FY 2003

The President's budget request for the Food and Drug Administration for fiscal year (FY) 2003 (October 1, 2002-September 30, 2003) totals $1.727 billion, including $1.432 billion in budget authority and $295 million in user fees. The proposed increase of $123 million or nearly 8% above the FY 2002 estimate reflects the agency's central role in the Nation's defenses against the threat of terrorism, as well as FDA's strong performance as the gateway for medical products.

Additional resources are earmarked for continuing the major intensification of FDA's updated counter-terrorism programs, inflation-related payroll adjustments, patient safety and generic drugs, and higher user fees anticipated under a reauthorized Prescription Drug User Fee Act (PDUFA). The highlights of the budget request are as follows:

$295 million for user fees, including $272 million anticipated for collection under PDUFA, whose reauthorization and enhancement for another five years are currently being discussed by FDA, industry, and other stakeholders. Additional user fees are proposed for the continued implementation of the Mammography Quality Standards Act ($16.4 million), export certification program ($1.6 million), and the color certification program ($5.1 million).

$159 million to continue support of FDA's counter-terrorism programs. Protecting all FDA-regulated products against willful contamination and ensuring the availability of medical products for the prevention or treatment of injuries caused by biological, chemical or nuclear agents are important FDA public health goals. Significant initiatives to improve the existing safeguards for the Nation's food supply, 80% of which is regulated by FDA, are among the agency's top priorities.

$28.6 million for inflation-related pay increases. This proposal is of particular importance for FDA, whose labor-intensive, science-based mission requires a sizable and highly qualified staff. The agency's payroll costs, by far the highest of all public health agencies, constitute 60% of FDA's budget.

$5 million for improvement of patient protection against medical errors involving the use of FDA-regulated drugs, biological products and medical devices. The proposal would finance improvement of reporting systems, expanded surveillance of risks associated with vaccines and other biological medications, and enhance FDA's ability to help identify potential product tampering.

$4.6 million to expand FDA's generic drugs program by hiring additional product reviewers, plant inspectors, and to more closely monitor the quality of imported generic drugs and bulk drug substances.

$5.2 million for FDA’s share in the continued development of a new financial management system for all components of the Department of Health and Human Services (DHHS). The new system is designed to reduce costs, improve data security, and provide timely and accurate financial information for FDA and all DHHS operating divisions.

$63.2 million for accrued retirement and health benefits whose funding will become FDA's responsibility under the proposed government-wide Managerial Flexibility Act. More than $8.45 million of the total amount is to be collected in proportionate amounts as part of the user fees charged under PDUFA and the other three FDA user fee programs. The proposed law is designed to provide federal managers with greater freedom in hiring, retaining and transferring personnel, and gives federal agencies wider latitude in managing property.

The budget proposal also assumes that FDA will achieve cost savings by the streamlining of operations, new management efficiencies, and consolidation of administrative functions and facilities. In addition, the agency will study the possibility of reengineering or outsourcing of such functions as management of real property, personnel, and administrative support.

####

FY 2003 Budget Summary

Notes: Includes FY03 funding for retirement accruals.
*FY 2002 Comparable shows '02 impact of administrative transfer and retirement accruals had these been in effect that year.
*BA=Budget Authority; S&E=Salaries and Expenses; UF=User Fees; and
*B&F=Building and Facilities.
*FTE do not include 89 in each year for reimbursables.

FY 2003 Budget Summary - Initiative Amounts

Note: Table reflects changes from 2002 to 2003 on a comparable basis for the consolidation of legislative and public affairs and retirement accruals, meaning that the 2002 numbers are shown as though those proposals had been in effect in 2002.
1/ The FY 2001 amount does not include $4.750 million one-time funding for vaccine research and development from the Public Health Social Services Emergency Fund for counter terrorism, but does include $1.75 million for physical security from the Public Health Service Emergency Fund.
2/ The FY 2003 request level does not does not include inflationary costs by each increase.

FY 2003 President's Budget for the Food and Drug Administration

• FY 2003 Budget Summary: PDF

FY 2003 President's Budget for Dept. of Health and Human Services

• Budget in Brief:   PDF   Rich Text File
• All Purpose Table:   PDF Microsoft Excel Format

FDA News Page   |   FDA Home Page

Office of Public Affairs
Web page uploaded by tg 2002-FEB-04.