Dietary rules heighten food fight over FDA

Whether the issue is drugs or diet, not everyone says the government needs to take a stronger role. Some cite the need is for greater self-regulation by consumers. Already, changing consumer demand is prompting food companies to adapt by introducing more whole-grain breads and cereals, for example.

And in some ways, Washington is doing more than ever on issues related to health. Not since Teddy Roosevelt has the nation had a president so conspicuously committed to exercise and a healthy lifestyle as President Bush. Outgoing Health and Human Services Secretary Tommy Thompson made pedometers a fashion accessory in official Washington.

But the administration is seen as slow to respond to mounting evidence that some popular drugs may constitute serious health risks. And neither the White House nor the GOP-controlled Congress has promoted a stronger federal regulatory role. Last year's tobacco buyout dropped a provision that would have given the FDA regulatory authority over tobacco products.

More recently, an FDA whistleblower blasted the agency for aligning itself too close to the industry it is charged to regulate. The agency's David Graham, testifying on the withdrawal of the drug VIOXX by Merck, said the FDA sees the drug industry as a "client," he said. As a result, it "over-values the benefits of the drugs it approves and seriously undervalues ... drug safety."

Others at the FDA, which did not return calls for this story, say the agency takes all allegations of safety risks seriously. "When drug safety issues are identified, they must be factored into the risk-benefit equation so that safe and effective drugs remain available to patients who need them," said Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research.

The Graham testimony marks a rare moment of congressional oversight on the FDA and drug safety. "We shouldn't have to wait 15 years to hear ... what is going on in our most important public safety agency," says Larry Sasich, a research analyst with Public Citizen, a leading critic of the FDA on drug safety.

Early on, the 109th Congress will be taking up a new version of the medical malpractice bill, which includes a controversial provision to shelter drug companies from liability for any product that has been approved by the FDA. Critics say this fight over this bill reopens the issue of congressional oversight of the industry - which has contributed more than $116 million to federal campaigns since 1990 - and will discourage the industry from withdrawing unsafe drugs.

"There is a financial risk for companies if they don't take unsafe drugs and products off the market," says Joanne Doroshow, executive director of the Center for Justice and Democracy in New York. "Under this medical-malpractice bill, that financial incentive would be removed."

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