President’s FY 2008 Budget Advances FDA’s Public Health Goals, Including Improving Safety of Nation’s Food Supply
ROCKVILLE, Md., Feb. 5, 2007-The U.S. Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services, is requesting nearly $2.1 billion to protect and promote public health as part of the President's fiscal year (FY) 2008 budget—more than a 5 percent increase over the budget submitted to Congress last year.
The FY 2008 request, which covers the period of Oct. 1, 2007 through Sept. 30, 2008, includes $1.64 billion in budget authority and nearly $444 million in industry user fees. The budget proposal includes significant increases to strengthen food safety, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. The request also includes significant increases to cover higher infrastructure expenses and cost of living adjustments for FDA employees to support the agency's highly trained and specialized public health workforce. These investments will accelerate the availability of new and innovative medical products and help ensure the safety of the food supply.
"As the FDA enters its second century of service, our focus will continue on critical public health initiatives, including ensuring the safety of the food we eat and the safety and effectiveness of the medicines we take," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "The President's budget provides FDA with a sound approach for meeting its public health mandate and priorities for the American people."
The following are FDA's key proposed budget increases:
- Strengthening food safety ($10.6 million)
More than 250 different foodborne illnesses are food safety threats. Recent illnesses linked to fresh produce highlight the need for increased resources to strengthen food safety and enhance FDA's ability to reduce and respond to foodborne outbreaks. Additional funding will allow the agency to develop better methods to rapidly detect foodborne illness, track contamination to its source and help states, local jurisdictions and industry mitigate the risks of new outbreaks.
- Modernizing drug safety ($11.2 million)
FDA needs additional resources to build on the strong record of safe and reliable drugs that has made the agency a long-time international gold standard of drug regulation. FDA is proposing to further strengthen the science that supports its medical product safety system at every stage of the product life cycle, from pre-market testing and development through post-market surveillance and risk management. With added funds, FDA will increase staff devoted to review of annual safety reports, conduct a pilot program to review the safety profiles of new molecular entities and develop an electronic drug safety tracking system.
- Improving medical device safety and review ($7.2
million)
As medical devices become increasingly complex and integral to the delivery of health care, there is a growing need to bolster the system that ensures the safety of these products over their entire life-cycle. The resources will improve device safety by improving FDA's ability to identify, analyze and act on post-market safety information, hire additional staff to handle product recalls and deploy analytical tools to detect adverse events in medical devices on the market. FDA will also use these resources to meet its performance goals for medical device review.
- Conducting more—and more timely—generic drug
reviews ($5.6 million and $15.7 million in user fees)
Generic drugs generally cost 20 percent to 70 percent less than their brand-name counterparts and thus offer an attractive way of reducing healthcare costs associated with prescription drugs. FDA has made progress in the expedited review of applications for generic drugs, which have risen dramatically over the past six years. FDA is proposing additional funds for generic drug review as well as a new industry-funded generic drug user fee, which FDA estimates will generate $15.7 million in FY 2008.
- Other New User Fees ($27 million)
FDA is proposing two additional new user fees. The Reinspection User Fee ensures that laboratories and facilities that fail to comply with health and safety standards bear the cost of re-inspection. When FDA identifies violations during an inspection or issues a Warning Letter to an establishment, it conducts follow-up inspections to verify that the manufacturer or laboratory has taken corrective action. FDA estimates the re-inspection fee will generate $23.2 million in FY 2008. The Export Certification user fee, estimated at $3.7 million, will cover the cost of issuing export certificates required by several foreign governments when companies export food products. Currently FDA charges exporters for certificates in all FDA product areas except foods. Private sector exporters would bear the cost of the program, but would reap its benefits through the agency's enhanced ability to facilitate reports of their products.
- Cost of Living Pay Increase ($21.8 million)
At FDA, we rely on a world-class workforce to perform our public health priorities. The funds allow FDA to retain its highly-trained and specialized workforce and to recruit staff of the same caliber.
- White Oak Consolidation ($13.3 million)
During the past four years, FDA has been moving to a new campus in White Oak, Md., where FDA will eventually consolidate 7,700 employees located presently at 20 different sites across the Washington, D.C. region. Funding White Oak ensures that FDA programs can focus on high-impact health priorities without diverting funds to pay infrastructure costs. FDA's FY 2008 budget request will pay to move the 1,300 employees in the Center for Devices and Radiological Health to this facility.
For more information on the President's FY 2008 budget for FDA, visit: http://www.fda.gov/oc/oms/ofm/budget/documentation.htm.
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