Year 2000 Budget Proposal For FDA
The Clinton Administration's budget proposal for the Food and Drug Administration for fiscal year (FY) 2000 calls for total resources of $1,350 million, which includes a $216 million (18%) increase above the appropriations for FY 1999. This request, if enacted, will represent the largest addition to FDA's resources in the history of the agency. The budget authority request, which consists of the total request of $1,350 million minus $195 million in proposed user fees, is for $1,155 million. This requested sum is $173 million more than was appropriated for FY 1999.
The requested budget increase is essential for FDA's success in meeting two major ongoing tasks: the overall upgrading of the agency's scientific base which is critical for sound regulatory decisions; and, more specifically, the achievement of the next year's targets for several long-range, high-priority programs that are vital for the promotion and protection of the public health.
These programs include the President's initiatives on food safety, youth tobacco prevention, and bioterrorism, and the implementation of the FDA Modernization Act of 1997 (FDAMA) in the three critical areas of injury reporting, product safety assurance and premarket application reviews as set forth in FDA's strategic Plan for Statutory Compliance issued last November.
The Presidential food and tobacco initiatives are budgeted for a requested increase of $64 million. The bioterrorism initiative, whose funding is requested centrally through the Public Health and Social Services Emergency Fund, is allocated $13.4 million. The requested funding for the implementation of FDAMA is $95.5 million. Proposed user fees, both new and appropriated, total $195.0 million.
The following sections outline programs on the FDA's wish list for upgrading.
Injury Reporting
Product Safety Assurance
Premarket Application Review
Food Safety Initiative
Youth Tobacco Prevention
Bioterrorism
Seafood Inspection Program
User Fees
Other Requested Increases
Injury Reporting
$15.3 million has been earmarked for injury reporting. Errors in the use of regulated drugs and medical devices, together with adverse reactions to properly used drugs, cause thousands of deaths and injuries that could be prevented if the incidents were adequately documented and sufficiently understood. One of FDA's primary objectives for FY 2000 is to develop and implement a science-based system to improve the quality of information on adverse events and defects of FDA-regulated products, identify their causes, and implement strategies to prevent them.
Among other measures, FDA intends to move as rapidly as possible to an integrated, fully electronic system for adverse event reporting directly to the agency; improve the accuracy of such reports through the adoption of uniform coding and nomenclature systems; initiate a sentinel site program for medical device adverse event reporting; and develop mechanisms to provide effective feedback to the health care community and the public through outreach and education. Meeting these goals will require the hiring of 11 additional full-time FDA employees (FTEs).
$52.2 million, including 155 FTEs, have been requested for product safety. In order to continue ensuring the safety of regulated products and conform with statutory requirements, FDA needs to increase the frequency of inspections across all product areas. For human and animal drugs, biologics and medical devices the FDA will work toward the goal of inspecting each manufacturer every two years. The requested funding will enable the agency to focus on technical assistance to enhance industry compliance, and to integrate public health regulation with the states through contracts, partnerships, training and information sharing. The agency intends to fund additional inspections through contracts with state authorities, and to establish a national database of inspection statistics that will be available to local, state and federal health officials. The integrated system will eliminate duplication of effort while increasing inspectional coverage.
Of the requested increase, $20.4 million will be used to start construction of FDA's Los Angeles laboratory, a $40.4 million project needed to upgrade the agency's scientific capacity and consolidate three district sites in one location. An additional $3.0 million will be spent on the final construction phase of another addition to FDA's scientific base, which is the Arkansas regional laboratory.
$28.0 million (141 FTEs), including $11 million in budget authority and $17 million in user fees, were requested for premarket application review. To meet statutory requirements, FDA must shorten its review times for the premarket approval of products not supported by user fees. The budget request provides funds for various activities that serve this purpose, such as reengineering and automating the review processes; providing industry with up-to-date guidance and increased assistance to improve the productivity of the agency's interactions with the manufacturers and the quality of their submissions; and better targeting of FDA's laboratory support on emerging technologies.
In addition to these and other improvements across the board, the agency's request includes authorization to collect user fees for the processing of direct food additive petitions ($4.0 million), indirect food additive notifications ($6.0 million), and medical device applications for new devices (PMAs), PMA supplements, and complex 510(k)s, devices that are similar to other marketed products ($7.0 million). If granted, these user fees would be applied specifically to the supported products, and allow the agency to increase the speed of reviews of direct petitions, more consistently meet the review timeframes, and take other steps to help industry reduce the total product development time.
Food Safety Initiative
$79 million, including an increase of $30 million (156 FTEs), is requested for food safety. The Administration's Food Safety Initiative is a two year-old, long-range program that marshals the resources of several federal agencies behind a comprehensive effort to minimize the outbreaks of foodborne illness, a persistent hazard that affects the health of millions of Americans and costs the United States economy several billion dollars annually. FDA contributes to the implementation of the initiative in close cooperation with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture.
In FY 2000, FDA's contribution to the program will include increased efforts to trace the causes of outbreaks through the food production and distribution chain; a strengthening of scientific research to identify pathogens, assess their hazard to the public health, and contain them; an increase in the frequency of inspections in high-risk establishments, including more than doubling the inspections of foreign processors of imported food; and greater efforts to disseminate food safety education among food service workers.
$68 million, including an increase of $30 million (15 FTEs), would be used to prevent teenagers from becoming smokers. Each day, 3,000 American teenagers become regular smokers and, as a result, one-third of them will die prematurely—a tragic loss that each year costs the country 420,000 lives and more than $50 billion for health care. FDA, which has a leading role in the Administration's initiative to protect our youth against tobacco, by the end of FY 1998 completed contracts with authorities in 43 states and territories to enforce the agency's ban on the sale of tobacco products to minors.
To reach the goal of 50% reduction in young people's use of tobacco in seven years, FDA intends to have enforcement contracts with all states and territories by FY 2000, and use the requested funds to increase the number of compliance checks at retail outlets; step up its education campaign to strengthen the retailers' compliance with FDA's tobacco rule; eliminate—to the extent permitted by court order—certain forms of tobacco advertising directed at minors; and complete the classification of tobacco products under the Food, Drug and Cosmetic Act.
Not a high priority, but FDA has asked for $13.4 million (49 FTEs) from the Public Health and Social Services Emergency Fund to underwrite the agency's bioterrorism activities. FDA is currently involved in anti-bioterrorism activities as a member of an interagency group which was formed by the Office of Emergency Preparedness of the Department of Health and Human Services (DHHS) and includes the Department of Defense, Veterans Administration, CDC, and the National Institutes of Health.
As part of this group, FDA has proposed a regulation needed to identify drugs and biological products that could ameliorate or prevent the toxicity of chemical, biological, radiological or nuclear substances—a task made especially difficult because the products' efficacy cannot be ethically studied in humans. Under the Administration's bioterrorism initiative, FDA will use the requested funds for such measures as ensuring expeditious development and licensure of new vaccines for anthrax, botulinum and other toxins; providing an appropriate response to a potential biohazard event with trained and equipped investigators; developing a four-hour detection and decontamination methodology; and arranging for the seizure, removal, and/or destruction of any unsafe products.
Seafood Inspection Program (SIP)
FDA requests $15.7 million (172 FTEs), including $3.0 million in budget authority and $12.7 million in user fees, for additional seafood inspection. This program, which is currently under the National Marine Fisheries Service/National Oceanic Atmospheric Administration, provides voluntary inspections and certification services for fish and fishery products on a fee-for-service basis, and also addresses issues of product wholesomeness, economic integrity and quality. Under the budget proposal, the program is to be transferred to FDA's purview pending the development of legislation that would make the SIP a performance-based organization run more like a private business. The $3.0 million is proposed for training and other transitional costs associated with the program transfer; the proposed user fees are to cover the salaries of the seafood inspectors and other costs of running the program.
User Fees
The proposed budget calls for $195 million for user fees. In addition to the $12.7 million SIP user fees, the budget proposes the following payments for already authorized FDA services: $145 million under PDUFA II, including an increase of $13.2 million (59 FTEs) for continued acceleration of the drug review process; $14.8 million, which includes an inflationary increase of $0.4 million, for inspections and other activities conducted under the Mammography Quality Standards Act; and $5 million, including a $0.2 million to cover inflation, for export certification and color additive certification activities. The budget also includes $17 million in new proposed user fees for the review of direct and indirect food additive petitions ($10 million) and to enhance the review of medical devices ($7 million).
Other Requested Increases
- $16.3 million to pay the rent of the Government Services Administration, for which the agency estimates that in FY 2000 it will need a total of $100.2 million, including an estimated increase of $11.7 million, of which $0.2 million for additional needs of the drug review program is included in PDUFA user fees.
- The relocation of FDA's Center for Food Safety and Applied Nutrition to a new facility in FY 2001 will necessitate advance purchases of furniture, equipment, and other one-time costs anticipated to total in FY 2000 $4.6 million.
For more information: Larry Bachorik, Acting Associate Director, Office of Public Affairs, U.S. Food and Drug Administration, 5600 Fishers Lane, Park Lawn Building, Rockville, MD 20857. Tel: 301-827-6250.