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Wednesday, January 30, 2008

FDA a "Hollow Government" Agency

Resource shortfalls at the Food and Drug Administration were the focus of a House panel hearing yesterday. The House Energy and Commmerce subcommittee on Investigations and Oversight heard from members of FDA's Science Advisory Board who recently completed a report titled, "FDA Science and Mission at Risk." Among other things, the report highlighted how funding and staffing have not kept pace with FDA's ever-growing responsibilities to ensure the safety of the nation's food and drug supply.

One member of the board, Gail Cassell, spoke of the glaring problems the board saw when preparing the report:

It became rapidly apparent that the FDA suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities…Since every regulatory decision must be based upon the best available scientific evidence in order to protect the public's health, we concluded that American lives are at risk and that there is an urgent need to address the deficiencies.

But both members and witnesses recurrently brought the conversation back to resources. Another member of the board, Peter Barton Hutt, argued scientific problems at the agency cannot be fixed without an infusion of cash and an increase in staff:

The accumulating unfunded statutory responsibilities imposed on FDA, the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for premarket review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates — coupled with chronic underfunding by Congress — have conspired to place demands upon the scientific base of the agency that far exceed its capacity to respond. FDA has become a paradigmatic example of the "hollow government" syndrome — an agency with expanded responsibilities, stagnant resources, and the consequent inability to implement or enforce its statutory mandates.

Hutt called on Congress to double appropriations to FDA over the next two years and called on FDA to use that money to increase employment by 50 percent.

FDA Commissioner Andrew von Eschenbach also testified. Subcommittee chairman Bart Stupak (D-MI) pressed the commissioner on whether the president would be asking for an increase in funds for the agency when he releases his FY 2009 budget request next week. Von Eschenbach said he had asked for an increase in funding for his agency but could not comment on the president's budget before its release.