Food safety is broken, ex-chiefs of FDA testify

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

"Simply put, our food safety system is broken," said David Kessler, who was named to head the agency by President George H.W. Bush and served 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 a hearing of the House Oversight Committee in Washington.

Lawmakers of both parties demanded changes at the FDA, which they said had 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," Rep. Henry A. Waxman (D., Calif.), chairman of the Oversight Committee, said as the panel heard testimony from FDA Commissioner Andrew von Eschenbach and three predecessors. "The FDA is an agency in crisis. We need to act now."

Before the hearing, von Eschenbach announced that he had created a position to coordinate food safety and that it would be filled by David Acheson, 51, director of the FDA's food defense office.

"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 in a statement.

Waxman said the food safety czar was "a reasonable idea."

But Waxman said Congress had expanded the regulatory agency's responsibilities since 1994 without providing enough additional funding.

The Senate is debating a reauthorization of the law governing the FDA's drug-approval process. The legislation would increase user 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" that the regulatory agency needs an overhaul, said Rep. Thomas M. Davis 3d (R., Va.).

"In recent years, the FDA has stumbled through some high-profile missteps," Davis said, citing the withdrawal of Merck'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 the journal Science, told the panel that the agency had suffered from a lack of funding and staff during the last six years. 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," Kennedy said, "Congress has to give the FDA more resources."