FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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. 

T98-4                         Print Media:         301-827-6242
Feb. 2, 1998                  
                              Consumer Inquiries:  800-532-4440

1999 BUDGET PROPOSAL FOR FDA
Food Safety and Youth Tobacco Prevention
Receive Increases

The Clinton Administration's budget proposal for the Food and Drug Administration for fiscal year (FY) 1999 calls for total resources of $1,264.2 million, $187.4 million above the current estimate for FY 1998. The budget authority request is for $970 million, $45 million more than the estimate for FY 1998.

The request is highlighted by a significant increase of the current $24 million authorization for FDA's role in the President's Food Safety Initiative. One-half of the requested additional $50 million is earmarked for the President's Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables. Another major increase request is for an additional $100 million for FDA's Youth Tobacco Prevention Program. The budget proposal also includes $294.1 million in user fees, $166.4 million of which represents existing programs.

These are the main components in the President's FY 1999 funding proposal for FDA:

Food Safety Initiative: $74 million. The Administration's Food Safety Initiative is a comprehensive program that coordinates the efforts of FDA, the U.S. Department of Agriculture (USDA), the Centers for Disease Control and Prevention (CDC), and the Environmental Protection Agency to improve consumer protection against foodborne illness, which currently causes the death of up to 9,000 Americans a year. The focus of the initiative is on more efficient monitoring of the food supply through implementation of improved safety systems; an expanded "early warning" and surveillance system; strengthened coordination between State and federal agencies responsible for responding to foodborne disease outbreaks; improved food handling practices of consumers and retail food service establishments through education; and better risk assessment and more rapid and accurate detection and characterization of foodborne hazards. To carry out these additional activities, the budget proposal provides for 250 additional full-time (FTE) FDA employees.

Youth Tobacco Prevention: $134 million. Tobacco products are responsible for more than 400,000 deaths and more than $50 billion in health care costs a year. FDA's program -- carried out with state and local authorities -- is designed to reduce easy access to cigarettes and other tobacco products by young people. Currently one million of them become regular smokers each year and, as a result, one-third of them will die prematurely. To help reach the goal of a 50 percent reduction in the use of tobacco products by children within seven years, the budget request includes $35 million for compliance outreach, $75 million in enforcement and evaluation, and $24 million in product regulation.

Prescription Drug User Fees: $132.27 million. The request, which includes an increase of 120 FTEs, continues the highly successful agency program to speed up the review of drugs and biologics which was first legislated in 1992 and was reauthorized by the FDA Modernization Act of 1997. During its first five years (FYs 1993-1997) the program -- called PDUFA, the acronym for Prescription Drug User Fee Act of 1992 -- consistently exceeded demanding performance goals, and by the end of 1997 reduced to 12 months the 30-month median time that used to be required for a drug review in the late 1980s. The accomplishments of PDUFA, which contributed to a sharp increase in the number and quality of new applications, were acknowledged last year by the Innovations in Government award from the Harvard University Kennedy School of Government. During the 5 years of the reauthorized PDUFA, FDA will continue improving its review performance and focus on measures designed to reduce the overall development time for drugs and biologics.

Mammography Quality Standards (MQSA) And Other Existing User Fees: $14.385 million. To ensure that women continue to have access to quality mammography, an effective tool in reducing breast cancer mortality, FDA requests a $419,000 inflation-based increase in MQSA user fees. These funds will enable FDA and state authorities to continue annual inspections of about 8,300 mammography facilities. In addition to MQSA fees, the agency will continue collecting user fees for certification of color additives ($4.79 million) and exports ($1 million).

Proposed New User Fees: $127.7 million. Industries regulated by FDA derive from the agency's activities valuable benefits, including increased consumer confidence in their products, protection against liability, and improved competitive position in overseas markets. The Administration therefore plans to work with Congress, industry, and other interested parties to develop proposals for new user fees for such FDA activities as postmarket surveillance, evaluation of medical devices, import inspections, and review of generic and animal drugs.

(Table upon request.)

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