U.S President's FY 2009 Budget

Feb 8, 2008
President's FY 2009 Budget Advances Food and Medical
Product Safety, and the Safety of FDA-Regulated Imports

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

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
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.

Source: FDA