President’s FY 2009 budget advances food and medical product safety, and the safety of FDA-regulated imports

February 4, 2008 — /FDA/ — 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. It would be a 5.7 percent increase over the budget that FDA received for the current fiscal year.

The FY 2009 request, which covers the period of October 1, 2008 through September 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 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,” says Andrew C. von Eschenbach, M.D., Commissioner of FDA. “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.”

FDA primarily delivers its public health mission through its highly trained professional workforce. During FY 2009, 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. 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 FDA’s key proposed budget increases:

Protecting America’s food supply ($42.2 million)

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 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 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, 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 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, 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.



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