HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.
Today's action supports the fundamental change in strategy currently underway at FDA to adapt to the demands of the rapidly growing and changing global economy. These funds will expedite implementation of the strategy outlined in the Action Plan for Import Safety and the complementary Food Protection Plan, both released in November 2007.
"Last year we outlined important changes in how this nation deals with imports. We are moving from an intervention strategy - where we stand at the border and try to catch things that are unsafe - to an integrated strategy of prevention with verification. We are rolling the borders back and seeking to build safety and quality into products at every step of the way before they reach American consumers," Secretary Leavitt said.
The Secretary continued, "Combined with crucial legislative proposals, this increase will allow FDA to continue to transform its regulatory strategies to meet the challenges of the evolving global marketplace. I urge Congress to act quickly to give FDA the authority and funding it needs to enhance the safety of our food and medical products."
Under the budget amendment, FDA will be able to expedite steps to improve import safety, including:
- FDA will significantly expand its reach beyond American borders by establishing a presence in five countries or regions and by implementing other measures that will help ensure greater foreign compliance with FDA standards.
- Another initiative will offer expedited entry for goods bearing certification by trusted parties.
- FDA will modernize its information technology infrastructure.
- Finally, FDA will conduct at least 1,000 more foreign inspections of food and medical product facilities and an additional 1,000 domestic inspections with funds in the budget amendment.
The increase brings the Administration's total proposed increase in the FDA's budget for FY 2009 to $404.7 million - a 17.8% boost in funding from FY 2008.
Some new authorities requested for federal agencies in the Action Plan for Import Safety that Congress has not yet granted include:
- Authorizing FDA to accredit highly qualified third parties to evaluate compliance with FDA requirements.
- Authorizing FDA to require certification of designated high-risk products as an additional condition of importation.
- Authority to refuse admission of imports from a firm who delayed, limited, or denied FDA access to its facilities.
- Empowering FDA to issue a mandatory recall of food products when voluntary recalls are not effective.
"FDA's mission to protect and promote the health of the America public will be greatly aided by these additional funds to implement our strategic plan," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "FDA has already embarked on an ambitious program to transform the Agency. This added funding will ensure that FDA can move ahead with these proposals more rapidly."
Consistent with the Administration's emphasis on fiscal discipline, the budget amendment is fully paid for within budgetary totals.
The budget amendment proposes the following increases for core FDA programs:
Protecting America's Food Supply (+$125 million)
The increase allows FDA to intensify actions to implement FDA's Food Protection Plan. Announced on November 6, 2007, the Food Protection Plan is an integrated, risk-based strategy to help ensure the safety of domestic and imported food and feed. The $125 million increase adds to the $42.2 million increase proposed for food protection in the budget announced in February 2008.