FDA Science Board Dire on Agency's Health

WASHIGNTON—In a Jan. 29 House Energy and Commerce Committee hearing, the FDA Science Advisory Board presented a report detailing how public health is at risk due to a weak and struggling FDA. In fact, Peter Barton Hutt, a former FDA chief counsel, told the committee FDA's enforcement resources are stretched thin, the agency is "hanging on by its fingertips," and the funding for FDA should be doubled over the next two years.

The 300-page report is the culmination of a year-long review by a distinguished panel of experts. It concluded the health of FDA’s scientific and regulatory programs reflect the lack of resources available to support the agency’s scientific base, hire and train a broadly capable scientific workforce, and build a sophisticated and modern information technology infrastructure.

"What makes this report so extraordinary is the qualifications of the individuals who wrote it, the year-long process to put it together, and the depth of analysis that supports its conclusion: FDA’s mission is at risk for lack of support for its scientific capabilities," said Jane Henney, M.D., former commissioner of FDA, currently senior vice president and provost for Health Affairs, University of Cincinnati, adding FDA's need for more funding should be obvious.

Don Kennedy, Ph.D., former FDA commissioner and editor-in-chief of Science, noted: “FDA can’t improve its science, prepare for the future, or protect American consumers without significant additional resources. The Administration and Congress are starting now on the FDA’s FY 2009 budget and must fix this critical problem."

In fact, FDA and Health and Human Services gave the President a fiscal year 2009 budget request 5.7-percent above current year funding. The 2009 request, which covers the period of Oct. 1, 2008 through Sept. 30, 2009, includes $1.77 billion in budget authority and $628 million in industry user fees. The focus of the budget is on food safety, drug safety, generic drug approvals and reviews of medical devices. Other than the $42.2 million proposed increased for food safety, the budget does not mention spending on implementation and enforcement of either the Dietary Supplement Health & Education Act (DSHEA) or dietary supplement GMPs (good manufacturing practices); these fall under the Food Program, which is requesting a 6.4-percent increase in the proposed 2009 budget.

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