President George W. Bush’s administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the FDA. He also called on Congress to act quickly on the budget amendment and pending Administration legislative proposals to strengthen the FDA.
The increase brings the administration’s total proposed increase in the FDA's budget for FY 2009 to $404.7 million _a 17.8 percent boost in funding from FY 2008.
The 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, according to the FDA.
“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,” said Health and Human Services (HHS) Secretary Michael Leavitt.
“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,” Leavitt added.
Under the budget amendment, FDA said it will be able to expedite steps to improve import safety, by:
- Expanding 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;
- Offering expedited entry for goods bearing certification by trusted parties;
- Modernizing its IT infrastructure; and
- Conducting 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.
Some new authorities requested for federal agencies in the Action Plan for Import Safety that Congress has not yet granted include:
- Authorizing the FDA to accredit qualified third parties to evaluate compliance with FDA requirements;
- Authorizing the FDA to require certification of designated high-risk products as an additional condition of importation; and
- Authorizing the admission refusal of imports from any firm who delayed, limited or denied the FDA access to its facilities.
“FDA’s mission to protect and promote the health of the American public will be greatly aided by these additional funds to implement our strategic plan,” said Andrew C. von Eschenbach, MD, commissioner of the FDA. “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.”