President's FY 2009 Budget Advances Food and Medical Product Safety, and the Safety of FDA-Regulated Imports

ROCKVILLE, Md., Feb. 4, 2008--The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting nearly $2.4 billion to protect and promote public health as part of the President's fiscal year (FY) 2009 budget—a 5.7 percent increase over the budget that the FDA received for the current fiscal year.

The FY 2009 request, which covers the period of Oct. 1, 2008 through Sept. 30, 2009, includes $1.77 billion in budget authority and $628 million in industry user fees.

The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. The request also includes funds to cover cost of living increases for FDA employees that perform the agency's scientific and highly specialized public health mission. These investments build on the increases that the FDA received for FY 2008 and will help ensure the safety of the food supply and accelerate the availability of new, safe, and innovative medical products.

"The FDA is committed to protecting and promoting the health of the American people," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "This budget enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety and development of drugs, vaccines, devices, and other medical products."

The FDA primarily delivers its public health mission through its highly trained professional workforce. During FY 2009, the FDA will experience a full-time equivalent staff increase of 526. The FY 2009 budget supports additional staff for priority areas such as food defense and food safety, and drug, blood, and human tissue safety programs. The FDA will also work to assure the safety of domestic and imported food and medical products by conducting more domestic and foreign inspections and more inspections of high risk foods.

The following are the FDA's key proposed budget increases:

Protecting America's Food Supply ($42.2 million)

The FDA's Protecting America's Food Supply initiative integrates food safety and food defense and uses a comprehensive, preventative, and risk-based approach to safeguard the food supply and the American homeland. The investment allows the FDA to implement components of the Administration's Food Protection Plan, Import Safety Action Plan, and December 2007 agreements with China.

The foundation of the FDA plan is to increase its focus on prevention, to identify potential food threats to the food supply and counteract them before they harm consumers. The FY 2009 increase will allow the agency to focus on the most important food defense and food safety issues throughout the entire life cycle of foods, from production through consumption. In FY 2009, the FDA will devote more workforce and resources to food production and handling sites, whether they are located in the United States or abroad.

Medical Product Safety and Development ($17.4 million, $79.0 million user fees)

This initiative provides targeted resources to improve the safety of human and animal drugs, blood, human tissues, and medical devices. The resources in this initiative will strengthen the FDA's ability to effectively monitor the safety of medical products, including imported products. The agency will also help medical product manufacturers develop new products to treat life-threatening diseases and conditions.

In 2007, Congress enacted the Food and Drug Administration Amendments Act (FDAAA). The FY 2009 budget implements new drug and medical device safety programs in FDAAA that are funded by user fees. As a result, the FDA will strengthen its ability to regulate medical products and assure the safety and effectiveness of these products for the American public.

Management Efficiencies

The FY 2009 budget also captures the productivity savings (-$8.9 million) generated by recent FDA investments and reinvests the savings in priority food safety and medical product programs.

For more information on the President's FY 2009 budget for the FDA, visit: http://www.fda.gov/oc/oms/ofm/budget/documentation.htm

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