Senate gives FDA $265 million in Defense supplemental ’08 funding

The Senate on Friday gave the Food and Drug Administration $265 million to beef up inspections of food products and drugs manufactured abroad.

The money was included in the 2008 Defense department supplemental appropriations legislation passed by the Senate, but President Bush has threatened to veto the bill because it includes funding for domestic programs such as expansion of educational benefits for veterans.

Sen. Herb Kohl, D-Wis., said during a floor debate on the bill that FDA Commissioner Dr. Andrew von Eschenbach "called me himself to stress the need for this funding. The FDA needs to get its house in order on food and drug safety, and these funds are targeted to do just that."

The supplemental budget includes $48.5 million for the FDA's Center for Drug Evaluation and Research and related field activities for the Office of Regulatory Affairs, which conducts inspections of foreign drug manufacturing plants.

The funding is related to FDA officials' testimony that the agency does not have the proper resources to inspect foreign drug plants. Eschenbach told a House oversight committee last month that FDA needed between $67 million and $71 million per year to conduct biennial inspections of foreign facilities, including Chinese plants that made a contaminated blood thinner linked to the deaths of 81 Americans. FDA had requested only $11 million in its fiscal 2008 budget and $13 million in fiscal 2009 for the inspections.

Eschenbach told the committee that with more resources FDA could upgrade its information technology system, expand its foreign presence and improve cooperation with its foreign counterparts in the next five years.

Rep. John Dingell, D-Mich., chairman of the House Energy and Commerce Committee, told Eschenbach at the hearing that he found it "indefensible" that the FDA would not seek resources it needed to "protect the American people," leading to the increased budget.

The supplemental budget also includes $119 million more for the Center for Food Safety and Applied Nutrition. The FDA's fiscal 2008 food protection budget is $619.6 million, and the agency requested less than a 7 percent increase to $661.8 million for fiscal 2009.

Sen. Ted Kennedy, D-Mass., chairman of the Senate Health, Education, Labor and Pensions Committee, and Rep. Henry Waxman, D-Calif., chairman of the House Oversight and Government Reform Committee, said they viewed such funding as "grossly inadequate" in a letter written to the Government Accountability Office in January. At the hearing, the FDA estimated illnesses from just 13 food-borne pathogens would result in more than 13 million medical cases and cost $57 billion annually.

The Defense supplemental budget also provides $23.5 million for FDA's Center for Biologics Evaluation and Research; $10.7 million for the Office of Veterinary Medicine; $35.5 million for the Center for Devices and Radiological Health; $6 million for the National Center for Toxicological Research; and $21.8 million for other activities.