ROCKVILLE, Md., Feb. 1 /PRNewswire/ -- 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
percent -- 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.
These are the main funding requests in the President's budgetary proposal
for FDA:
Injury Reporting: $15.3 million. 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).
Product Safety Assurance: $52.2 million, including 155 FTEs. 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 statisticsthat
will be available to local, state and federal healthofficials. 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.
Premarket Application Review: $28.0 million (141 FTEs), including $11
million in budget authority and $17 million in user fees. 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). The Administration's Food Safety Initiative is a 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 educationamong food
service workers.
Youth Tobacco Prevention: $68 million, including an increase of $30
million (15 FTEs). 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 percent 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.
Bioterrorism: $13.4 million (49 FTEs) from the Public Health and Social
Services Emergency Fund. 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): $15.7 million (172 FTEs), including $3.0
million in budget authority and $12.7 million in user fees. 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: $195 million. 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, 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. In addition, 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.
SOURCE Food and Drug Administration
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