FDA Board Calls for Funds

WASHINGTON—FDA's Science Board presented a report Dec. 3 on the state of agency affairs and public health, stating the nation's food supply is at risk, as are the regulatory systems and oversight of the nation's drug and device supplies. In the report, the board’s subcommittee attributed the agency’s deficiencies to overwhelming demands and stagnant, disproportionate resources. They concluded: "This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public."

Conducted by a distinguished panel of experts, the year-long review generated 300 pages detailing the state of FDA's scientific and regulatory programs, concluding the quality of the agency’s actions and programs is tied to the level of resources provided by Congress. The report called for increased funds to support the agency's scientific base, including hiring a broadly-capable scientific workforce, and building a sophisticated, modern information technology infrastructure.

Among the agency’s deficiencies the board linked to underfunding were: inadequate inspections of food manufacturers, a weak food import system, depleted staff, high turnover, lagging knowledge and use of technologies,

Former FDA commissioners weighed with reactions to the report. "Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the FDA,” said Mark McClellan, M.D., former FDA commissioner and chairman of the new Reagan-Udall Institute. “As this new report makes clear, our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better."

Former FDA commissioner, Don Kennedy, Ph.D., now editor-in-chief of Science magazine, added: "FDA can't improve its science, prepare for the future or protect American consumers without significant additional resources. Congress is negotiating FDA's FY 2008 (current year) budget right now and can start to fix this critical problem."

And Jane Henney, M.D., now senior vice president and Provost for Health Affairs, University of Cincinnati, noted FDA’s need for more resources should be obvious. She stated: “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."

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