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Former FDA Chief Says Agency Is “Broken”

May 7, 2007
Another food safety expert is questioning the Food and Drug Administration’s ability to provide safeguards for the nation’s food supply. This time the criticism is coming from the man who used to head the agency, Dr. David Kessler.

“Simply put, our food safety system is broken,” Kessler told the House Oversight and Government Reform Committee.

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The hearing was called to delve into the growing number of high profile – and deadly -- breakdowns in the nation’s food inspection system, from last fall’s spinach E. coli cases to the current pet food contamination.

Kessler attributes many of the problems to what he called “a confluence of factors,” chronic under-funding, a lack of enforcement authority, and severely outdated scientific and regulatory frameworks. It’s all led, he says, to a lack of confidence in the FDA.

Kessler, who served as head of the FDA during the Clinton Administration, said part of the problem is due to globalization of markets. But the bigger problem, he argues, is today’s FDA is only geared to reacting to problems, not stopping them from occurring in the first place.

“We have no structure for preventing food-borne illness in this country. The reality is that there is currently no mandate, no leadership, no resources, nor scientific research base for prevention of food safety problems,” Kessler said. “There is no one in the executive branch with the clout and Authority to prevent food-borne illness.”

Kessler traces a two-decade debate about the agencies expanding role in drug approval and safety. He says he has watched as more and more resources are allocated to the FDA’s drug approval process and management. Kessler says its time to allocate more resources to food safety.

“Food safety cannot be delegated to second-tier management within the agency, and the fact is that food is a second-tier priority within the FDA,” Kessler charged. “In addition, the current structure is fragmented in FDA. Responsibilities for food are spread across the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the Office of Regulatory Affairs.”

Kessler urged the committee to work with the Administration to strengthen FDA by meeting its resources needs and by unifying and elevating food safety leadership within FDA and the Department of Health and Human Services (HHS).

Committee chairman Henry Waxman (D-CA) agreed with Kessler that there were clear warning signs that the “FDA is in crises.” He said the committee would focus on agency budget cuts, its ability to enforce regulations and the legal authorities the agency has to do its job.

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