Funding Boost Allows FDA to Conduct More Inspections

The deaths of more than 100 people from contaminated medication made in China and the illness of many others following a nationwide food-borne salmonella outbreak have led the Bush administration to accede to a congressional demand for more food and drug inspectors.

Mike Leavitt, secretary of Health and Human Services, submitted an amended budget request for Fiscal 2009 in early June that included an additional $275 million for the Food and Drug Administration (FDA) to pay for more inspections. The additional funds will be used to place FDA inspectors in more countries, fund an initiative to offer expedited entry for goods with“ certification by trusted parties,” modernize the FDA's information technology infrastructure, and allow the agency to conduct at least 1,000 more foreign inspections of food- and medical-product facilities and an additional 1,000 domestic inspections.

“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,” Leavitt said in a written statement.

The $275 million request when added to earlier Bush budget increase requests would bring the FDA's total proposed budget to $2.4 billion, or an 18 percent boost from the current fiscal year.

The proposed increase follows the deaths of 149 patients, according to the FDA, from allergic reactions to contaminated doses of the blood-thinning drug heparin that were produced in China. It also comes on the heels of a nationwide salmonella outbreak that has sickened people in multiple states.

After months of budget hearings, Democrats and some Republicans in Congress had repeatedly chastised administration officials for not seeking more funds to adequately inspect the nation's medications and food. FDA officials eventually wrote in a letter to members of Congress that an additional $275 million would be helpful.

Several advocacy groups, including the FDA's own Science Board, have issued reports that said the agency is badly under-funded for its mission.

The funds would be added to the Fiscal 2009 draft Department of Agriculture funding bill, and so would not be available until well into 2009. The prospect of such a delay drew fire from some in Congress, including Sen. Arlen Specter (R-Pa.).

The administration's request “is drastically hindering necessary immediate relief by delaying the funding for eight or nine months,” Specter wrote in a June 10 letter to Leavitt. “The FDA needs this money now to save lives.”

The administration's formal Fiscal 2009 request will likely override an effort by the Senate and House to include a $275 million FDA increase in the emergency supplemental funding bill (HR 2642) now under consideration, which would provide the funds by September 30, the end of the current fiscal year. The legislation included $100 million explicitly for “drug, device, and biologics safety,” such as increased foreign and domestic facility inspections and improved FDA laboratory infrastructure.

The FDA has blamed insufficient funding for the steep drop in inspections—56 percent from 2003 to 2007—of food-producing facilities. The decrease has continued this year, and the FDA plans to hire more inspectors once it has the additional funds specified in the legislation.

More information on the additional FDA budget request is posted at<www.fda.gov/bbs/topics/NEWS/2008/NEW01849.html>.▪