(June 12) As the U.S. Food and Drug Administration struggled to pinpoint the source of a salmonella outbreak linked to fresh tomatoes, the agency announced it was increasing its budget request for fiscal year 2009 by $275 million.

U.S. Health and Human Services Secretary Mike Leavitt on June 9 said the Bush administration was amending its budget and called on Congress to act quickly on the request and pending proposals from the administration to strengthen the FDA.

The request for $275 million in added funds supports “the fundamental change in strategy currently under way at FDA,” an agency news release said. The FDA said the funds will speed the implementation of the Action Plan for Import Safety and the Food Protection Plan, both released in November.

Rolling back the borders

“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,” Leavitt said in the release.

Under the budget request, the FDA will establish a presence in five countries, and the agency said the funding will allow it to 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 fiscal year 2009 to $404.7 million — a 17.8% boost from fiscal year 2008.

“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,” FDA commissioner Andrew von Eschenbach, said in the news release. “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.”

Salmonella outbreak illustrates the need

Rep. Rosa DeLauro, D-Conn., said in a statement that the administration was “finally listening to the many voices” calling for increased funding for FDA.

“The current salmonella outbreak involving tomatoes is a prime example of the battles facing the FDA and how necessary the additional funds will be to allow the FDA to combat future outbreaks,” she said in the statement, calling the $275 million a “down-payment for the future of the FDA.”

Authority requested from Congress

The release noted that 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 that 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 seeks more money to fight outbreak