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