HHS department wants $275m more for FDA

The US Food and Drug Administration is seeking additional emergency funding to the tune of $275m to allow it to carry out oversight duties with respect to medicinal and food products, according to Health and Human Services Secretary Michael Leavitt.

This request comes against a background of severe criticism of the agency in terms of its failure in preventing the import of fake and substandard drugs, including the scandal of contaminated heparin, as well as tainted food products.

Leavitt has called on Congress to move swiftly on this budget amendment. If approved, the funding would be in addition to the agency's proposed 2009 budget of $2.4bn.

"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," said Leavitt.

"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," he added.

Out of the requested new funding, $125m is earmarked for protecting the US food supply, $100m will go towards measures to ensure safer supplies of drugs, devices and biologics, and $50m will go towards modernising the agency's science capabilities and workforce.

It is intended that the  agency, which has seen its staff numbers decline since the early 1990s, will be able to expedite steps to improve import safety, including:

• a significant expansion of the FDA's reach by establishing a presence in five countries or regions and by implementing other measures that will help ensure greater foreign compliance with the agency's standards;


• offering expedited entry for goods bearing certification by trusted parties;


• modernisation of its information technology infrastructure; and


• an increase in inspections. The agency wants to carry out at least 1,000 more foreign inspections of medical and food product facilities and an additional 1,000 domestic investigations with funds in the budget amendment.