on assurances from the FDA

Food Safety System Broken - The Boston Globe

WASHINGTON -- Regulators don't have the money, equipment, and staff to keep industrial chemicals, salmonella, and E. coli from contaminating the US food supply, former commissioners of the Food and Drug Administration said.

"Simply put, our food-safety system is broken," said David Kessler, who headed the agency from 1990 to 1997.

"The reality is that there is currently no mandate, no leadership, no resources, nor scientific research base for prevention of food-safety problems," Kessler told the House Oversight Committee yesterday.

Lawmakers from both parties demanded changes at the FDA, which they said has failed to meet modern challenges in its duties to approve new drugs and to monitor the safety of the food supply. They cited recalls of pet food containing an industrial chemical, peanut butter with salmonella, and spinach with E. coli bacteria.

"Incompetent government can have deadly consequences," committee chairman Henry Waxman, a California Democrat, said as the panel heard from FDA Commissioner Andrew von Eschenbach and three of his predecessors. "The FDA is an agency in crisis. We need to act now."

Before the hearing, Von Eschenbach named David Acheson, 51, director of the FDA's food defense office, to a new position created to coordinate food safety.

Congress has expanded the FDA's responsibilities since 1994 without providing enough funding, Waxman said.

The Senate is debating a reauthorization of the law governing the FDA's drug-approval process. The legislation would increase fees paid by the industry and require more active surveillance of potential health risks of medicines after they go on the market.

There's a bipartisan consensus the FDA needs an overhaul, said Representative Tom Davis, a Virginia Republican. "In recent years, the FDA has stumbled through some high-profile missteps," he said, citing the withdrawal of Merck & Co.'s painkiller Vioxx from the market in 2004 after it was linked to heart attacks and strokes.

Donald Kennedy, FDA commissioner from 1977 to 1979 and now editor of Science magazine, said the agency has suffered from a lack of funding and staff. Its budget would need to be increased from $1.56 billion in fiscal 2007 to $2 billion in fiscal 2008 to fully restore its capabilities, he said.

"If we expect to have our spinach uncontaminated, our pet food safe, Congress has to give the FDA more resources," Kennedy said.

"We've seen a rapid transformation of the food safety system due to advances in production technology, rapid methods of distribution, and the globalization of food sources," von Eschenbach said.


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