FDA News
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FOR IMMEDIATE RELEASE
P04-10
February 2, 2004
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Media Inquiries: 301-827-6242
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President Requests Budgetary Increase,
Greater Food Defense Role for FDA in FY 2005
The Food and Drug Administration today announced that the President's budget
request for the agency in fiscal year (FY) 2005 (10/1/04-9/30/05) totals $1.8
billion, including $1.5 billion in budget authority and $350 million in user
fees. This represents an 8.8 percent increase over the FY 2004 level. The budget
authority increases total $138.9 million and savings from administrative efficiencies
and deferred facilities' repairs and improvements are $30.1 million, for a net
increase of $108.8 million.
The largest increase by far -- $65 million -- is earmarked for strengthening
the FDA's role in a new interdepartmental program for the defense of the Nation's
food supply. In addition to boosting the FDA's counterterrorism program, FY
2005 request also highlights substantial increases for FDA's reviews of medical
devices, protection against Mad Cow disease, and consolidation of the agency's
facilities in a single location in Maryland.
The proposed $65 million increase for the FDA's food defense program, one
of the Administration's highest priorities, is part of a joint budget request
developed by FDA, the U.S. Department of Agriculture's (USDA's) Food Safety
and Inspection Service (FSIS) and the Agricultural Research Service (ARS) in
cooperation with the White House Homeland Security Council. This counterterrorism
initiative is focused on the advancement of the following programs:
- Establishment of a joint FDA-FSIS Food Emergency Response Network (FERN)
of laboratories capable of analyzing thousands of food samples for biological,
chemical and radiological threat agents. The FY 2005 request will add 15 FDA-funded
state labs to the 10 FDA laboratories planned for FY 2004;
- Broader research focused on technologies, methods and tests providing effective
protection for the food supply;
- Increased FDA inspections of domestic and imported food to reduce contamination
hazards;
- Improved coordination with the Department of Homeland Security as part of
the government-wide Bio-Surveillance Initiative; and
- Stepped-up food-associated crisis- and incident-management activities.
Strengthening of the agency's capacity to identify, prevent, and respond to
terrorist threat is one of FDA's strategic goals, which also include using risk-management
principles to increase the efficiency of all FDA's activities; providing consumers
with better information about the benefits and risks of FDA-regulated products;
improving patient and consumer safety; and ensuring that the agency has a well
trained and highly motivated, world-class professional workforce.
“The President's budget request for fiscal year 2005 reflects the evolving
challenges we face in carrying out our mission of advancing and protecting the
public health," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "It
takes into account the escalating demands of food safety and security, especially
in the face of potential terrorist acts. And it will allow FDA to continue delivering
on our promise of making safe and effective new medical products available quickly,
in the most cost-effective way possible."
The request also includes the following major budgetary increases:
- $14,352,000 for the agency's payroll, to account for a 4.1 percent cost-of-living
increase for calendar year 2004 and a 1.5 percent cost-of-living increase
for calendar year 2005. The proposal is based on an FDA full-time staff of
10,779.
- $8,325,000 to support new FDA and USDA safeguards against Mad Cow disease
(Bovine Spongiform Encephalopathy, or BSE)
which were adopted following the recent discovery of an infected cow imported
from Canada. The requested resources will enable FDA to carry out additional
920 risk-based BSE inspections and 600 targeted sample collections and analyses
of both domestic and imported animal feed or feed components; fund 2,500 more
state inspections of animal feed firms; acquire further information on feed
firms and firms handling prohibited rendering materials; and strengthen the
states' infrastructures to monitor, and respond to, potential feed contamination
with prohibited materials.
- $25,555,000 to strengthen FDA's medical device review process by collecting
user fees under the Medical Device User Fee and Modernization Act (MDUFMA).
The program supplements FDA's appropriations for the agency's ongoing improvement
of the quality and timeliness of the reviews of premarket medical device applications,
certain supplements, and premarket notifications. This budget authority increase
will be augmented by an increase of $2,284,000 in additional user fees for
the Devices and Biologics programs.
- $5,000,000 to increase the Nation's preparedness to respond to biological,
chemical, and nuclear attacks. FDA plays a lead role in biodefense countermeasures
under Project BioShield, which helps ensure medical preparedness in the event
of war or a catastrophic event. The FDA's role includes rapid and effective
review of specialized products for such at-risk populations as military personnel,
first responders, those near nuclear facilities, as well as pregnant women
and immuno-compromised individuals and children.
- $20,628,000 in new budget authority to fund part of the $33,081,000-move
of FDA's Center for Drug Review and Evaluation (CDER) to the White Oak, Maryland
campus. The remainder will be covered by $2,361,000 from the FY 2004 appropriation
for recurring moving costs, and $10,092,000 in user fees under the Prescription
Drug User Fee Act (PDUFA). The move of an estimated 1,700 CDER personnel to
the new White Oak facility, which is scheduled for April, 2005, is part of
the FDA's efforts to address the President's Management Agenda.
- $40,385,000 in user fee increases consisting of $34,569,000 to be collected
under PDUFA; $2,284,000 for medical device review (as mentioned above); $3,000,000
for animal drug review program under the recently enacted Animal Drug User
Fee Act; $343,000 for mammography inspections; $45,000 for export certification;
and $144,000 for color certification.
In addition, the proposal calls for budgetary savings of $30,081,000 achieved
through FDA's efficiencies and delayed expenses. To fully embrace the President's
Management Agenda and the Secretarial priorities, FDA will continue seeking
administrative efficiencies by delayering its organizational structure, conducting
competitive sourcing reviews, modernizing its financial management system, and
consolidating its information technology infrastructure. To the extent possible,
essential buildings and facilities maintenance will be covered from carryover
funds.
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FDA FY 2005 Budget Summary
