FDA Report Says Nation's Health at Risk

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Another expert thinks that the FDA needs more money, but to really protect the public the agency's culture also needs changing.

"You need not only an overhaul of resources but an overhaul of philosophy on what safety and efficacy really means," said Dr. A. Mark Fendrick, a professor of internal medicine and professor of health management and policy at the University of Michigan.

"While a substantial increase in resources will enhance the scientific capabilities and capacity of the FDA, funding alone will not address the inherent tension between America's insatiable demand for immediate access for innovative products and an unwillingness to tolerate products that are anything but perfectly safe," Fendrick explained.

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Another FDA supporter also thinks that improving the FDA starts with money.

"There are a lot of problems in the FDA that can't be solved without more resources," said Steven Grossman, a spokesman for the FDA Alliance, which lobbies on behalf of the agency. "All the problems don't go away if you have more money, but there are a whole lot of problems you can't confront without money."

Grossman thinks there is need for another $450 million in unrestricted spending to start bringing the agency up to snuff. That request is currently winding its way through Congress. "We hope to get at least a third of that," he said. It's going to take several years of increased funding to get the FDA to where it should be, he added.

According to the report, the FDA's "inability to keep up with scientific advances means that American lives are at risk." The committee noted that while science had undergone radical changes, the agency' evaluation methods haven't hanged in more than 50 years.

In addition, the food supply is at risk, the report said: "Crisis management in [the] FDA's two food safety centers, [the] Center for Food Safety and Applied Nutrition (CFSAN) and [the] Center for Veterinary Medicine (CVM), has drawn attention and resources away from FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry, provide effective routine surveillance, and conduct emergency outbreak investigation activities to protect the food supply."

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