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| February 3, 2003 | Consumer Inquiries: 888-INFO-FDA |
The President's budget request for the Food and Drug Administration (FDA) for fiscal year (FY) 2004 (Oct. 1, 2003 - Sept. 30, 2004) totals $1.7 billion, including $1.4 billion in budget authority and $300 million in user fees. Budget authority increases total $79.6 million and savings related to the President's initiatives total $58.2 million. The agency's reductions include transferring funding to the new Department of Homeland Security, management savings due to de-layering, and information technology consolidations. The user fee increases total $37 million. The full time employee (FTE) total equals 10,753, which includes the adjustment for management savings, and does not include 89 reimbursable FTEs.
The request parallels FDA's top priorities of protecting our homeland against potential terrorist attacks, reducing preventable adverse health events, ensuring the agency has a strong science base, helping FDA's constituents get reliable, accurate, and relevant information about FDA regulated products, and implementing the President's management agenda.
Requested Changes:
Pay Increase + $23,283,000: This increase will cover a two percent inflationary increase in FY 2004. Payroll accounts for over 60 percent of FDA's budget.
Counter Terrorism - Food Safety + $20,500,000: The increase will provide grants to states, increased laboratory preparedness and funds to develop a foods registration system. The grants to the states will be used to build states' infrastructure to enable them to become part of the Laboratory Response Network and conduct direct federal food inspections. Increased laboratory preparedness will allow the agency's laboratory accreditation program to continue and to develop uniform scientific practices. The resources for the food registration system will allow FDA to develop and implement a system to register domestic and imported food facilities.
Patient Safety + $4,000,000: Medical errors are estimated to account for 40,000 to 100,000 deaths per year in hospitals alone. FDA will continue implementing Phase III of the Medical Product Surveillance Network (MedSun). FDA's new safety initiative, using modern health information systems, will provide faster and more complete information on safety problems associated with drugs and devices so adverse events involving these products can be avoided. Additionally, as part of the increase requested for generic drugs, FDA will place greater emphasis on preventing adverse events involving generic drugs.
Generic Drugs + $13,000,000: The increase will expand FDA's efforts to speed review of generic drug applications. Current savings to consumers from the use of generics is estimated to be in excess of $20 billion. In order to expedite the number of generic drugs available on the market, FDA plans to hire 40 FTEs to reduce review times, develop science, and support implementation of improved regulations for generic drug competition. FDA would also improve its post-market monitoring of adverse events of generic drugs as part of its effort to reduce avoidable complications involving FDA-regulated products.
Over-the-Counter Drugs + $1,000,000: OTC drugs provide an effective means to reduce consumer prescription costs for specified ailments. In an effort to provide greater consumer access to OTC drugs FDA will: Improve the regulatory process to provide the consumer faster access to OTC drug products without compromising safety issues; expedite the review of Rx-to-OTC switches; and, develop and finalize standards for analgesic, antiseptic, laxative, and sunscreen products for OTC use.
Best Pharmaceuticals for Children Act + $5,000,000: The request expands the joint effort between FDA and the National Institutes of Health (NIH) to ensure that medicines have been properly evaluated for use in pediatric populations and to improve the information physicians have to use when prescribing medicines to children. A total of $30 million is requested, $5 million for FDA and $25 million for NIH. FDA will expand its work with industry to develop pediatric specific information for on-patent drugs, and work with NIH to determine the specific research needed for frequently used off-patent drugs.
Medical Device Review + $1,000,000: The Medical Device and Radiological Health program has been re-engineered over the last decade to accomplish more with fewer resources and has changed its strategic direction by shifting its focus to high-risk, high-impact products to maximize the benefits on public health. The increase would allow the agency to work towards shoring up its device review infrastructure and contribute towards maintaining review performance.
Arkansas Regional Laboratory + $3,500,000: This laboratory, which is under construction, will provide critical laboratory analysis for FDA-regulated products in a seventeen-state radius. The request will allow for completion of Phase III of the construction and allow ARL to collaborate with NCTR on scientific issues.
CDER's Relocation to White Oak + $6,000,000: FDA headquarters are currently being consolidated into two locations to achieve considerable annual operating savings. Funding will support cabling and relocation services for the second phase of the Center for Drug Evaluation and Research (CDER) relocation that consolidates the offices and laboratories of CDER into one complex in the White Oak area of Silver Spring, Md.
Unified Financial Management System + $2,290,000: This system will integrate the financial management system of the Department of Health and Human Services (HHS) by providing information and promoting the consolidation of accounting operations that will substantially reduce the cost of accounting services throughout HHS.
Department of Homeland Security - $583,000: To support the establishment
of the Department of Homeland Security (DHS), FDA will transfer $583,000 to
DHS to allow states and major cities
to increase the preparedness of hospitals and public health systems. The objective
is to increase local preparedness, with national resources ready to be deployed.
President's Management Agenda: The President's management agenda is an aggressive strategy for improving the management of the federal government. It focuses on areas of management across the government where improvements and the most progress can be made to deliver results to the American people.
Current Law User Fees + $31,725,000: For the review of drug and biological products $249,825,000 is requested to support the Prescription Drug User Fee Act, an increase of $26,925,000. To improve the medical device review process $29,190,000 is requested for the second year of Medical Device User Fee and Modernization Act, an increase of $4,065,000. To ensure compliance with national quality standards for mammography, $16,576,000 is requested for the Mammography Quality Standards Act, an increase of $464,000. For the certification of color additives used in foods, drugs and cosmetics $5,079,000 is requested, an increase of $201,000 for Color Certification and a $1,570,000 is requested for Export Certification, an increase of $70,000.
Proposed Law User Fees + $5,000,000: FDA has submitted a proposal for a new user fee for the review of animal drug products. This proposal is patterned after the successful Prescription Drug User Fee Act. FDA will improve and expedite the review of animal drug pre-approvals.
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