FDA Budget Increase Not Nearly Enough

The proposed Food and Drug Administration (FDA) budget increase announced yesterday by President Bush won’t do much to improve the agency’s performance.  Under the new budget, the FDA – which regulates 80% of the nation’s <"http://www.yourlawyer.com/practice_areas/food_poisoning">food, <"http://www.yourlawyer.com/practice_areas/defective_drugs">drugs, vaccines, and <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices— will receive $2.4 billion for fiscal year 2009, starting October 1st.   If approved by Congress, this would be a 5.7% increase from the current budget.  Unfortunately, that increase will barely cover scheduled  pay raises and inflation, leaving the FDA with few new resources.

The FDA, which regulates $1.5 trillion of goods, has faced intense scrutiny in the past 18 months following an unusually high number of recalls, including E. coli-contaminated spinach grown in California, salmonella-tainted U.S.-made peanut butter, and contaminated pet-food ingredients imported from China that led to the largest-ever pet-food recall.

Last year, an advisory panel to the FDA issued a scathing review of the FDA and echoed ongoing concerns from groups such as the Institute of Medicine; the Government Accountability Office, the investigative arm of Congress; and Congressional committees.  The report revealed the agency is so under-funded and –staffed, it’s putting US consumers at risk.  The report went on to detail a wide variety of problems faced by the FDA such as inadequate inspections of manufacturers, depleted staff, increased responsibilities, and an obsolete information technology (IT) system.

“At least there’s not a substantial cut, but the agency won’t be able to do much with food or drug safety,” says William Hubbard, a former FDA associate commissioner who joined other former FDA officials in urging the agency’s budget be doubled over five years.

At a congressional hearing last week, one panel member, former FDA lawyer Peter Barton Hutt, said the agency needs its funding doubled over two years and its employee count increased by 50%.  Under Bush’s proposed budget, the number of full-time FDA employees would jump to 10,501, an increase of 932, or nearly 10%, from fiscal 2007.  The number of full-time positions in the FDA’s foods program would increase to 2,810 in fiscal 2009, but would be down 133 from fiscal year 2005.

The FDA says it plans to work with the industry to improve food safety, do more domestic and foreign food-plant inspections and open an office in China, the source of numerous food-safety problems last year.  The agency’s goals are modest, given the scope of the world food industry, including 136,000 domestic and 189,000 foreign facilities:  Increase inspections of domestic food facilities to 21,964 from 17,038 in fiscal 2007; inspect 200 foreign food facilities, up from 96 two years ago; and maintain inspection rates for foreign food imports.  The agency inspected 1.28% of the 9.4 million shipments that came to the USA in fiscal 2007.  That will drop to 1.26% in fiscal 2009.

Hubbard says there’s a chance that Congress, which has held numerous hearings on food safety in the past year, will bolster the FDA’s budget beyond what Bush has proposed, as it did with the fiscal 2008 budget.

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