The U.S. Food and Drug Administration (FDA) is requesting nearly $2.4 billion “to protect and promote public health” as part of the President’s fiscal year 2009 (FY09) budget. This amount would be a 5.7 percent increase over the budget that FDA received for the current fiscal year. The FY09 request covers the period of Oct. 1, 2008 through Sept. 30, 2009.

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.

“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.”

During FY09, FDA will experience a full-time equivalent staff increase of 526. The FY09 budget supports additional staff for priority areas such as food defense and food safety, as well as drug, blood, and human tissue safety programs. FDA will also work to ensure the safety of domestic and imported food and medical products by conducting more domestic and foreign inspections and more inspections of high-risk foods.

FDA’s key proposed budget increases support the following:

• 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 (see “Food Safety Plan Emphasizes ‘Effective Action’ to Prevent Food Supply Contamination,” CleanRooms magazine, December 2007, p. 8).

  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 FY09 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. FDA says the resources will strengthen its ability to effectively monitor the safety of medical products, including imported products. The agency will also help medical product manufacturers develop new technologies to treat life-threatening diseases and conditions.

  In 2007, Congress enacted the Food and Drug Administration Amendments Act (FDAAA). The FY09 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 ensure their safety and effectiveness for the American public.

• Management efficiencies. The FY09 budget also captures the productivity savings (