FDA Chief: Agency Needs More Power

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FDA Chief: Agency Needs More Power

 

Von Eschenbach Says FDA Needs Greater Authority to Ensure Food Safety

By Todd Zwillich

WebMD Medical News

Reviewed by Louise Chang,MD

Feb. 29, 2008

 

-- Saying his agency is at " a critical turning point, " the head of

the FDA is urging Congress to give new clout to the agency by summer.

 

FDA Commissioner Andrew von Eschenbach, MD says his agency needs more

authority to regulate both imported and domestic foods. It's also

looking for more money to regulate drug safety, medical devices, pet

food, and other products.

 

" I call on Congress to grant those new authorities by Memorial Day, "

von Eschenbach told reporters at the National Press Club in

Washington.

 

The FDA has been stung by a years-long string of drug safety concerns

and product recalls. The most recent recall involved the blood-

thinning drug heparin, manufactured by Baxter; the company's product

was supplied by a factory in China.

 

" I am aware of the need for radical and rapid change, " von Eschenbach

says. He acknowledged public concern over the FDA's handling of drug

and food safety problems. " We're looking for your support and your

patience as well as your trust and your confidence. "

 

In addition to drugs and medical devices, the FDA has responsibility

over a vast range of products, including food (except meat and

poultry), cosmetics, and dietary supplements.

 

FDA Critics

Critics, especially Democrats in Congress, have charged that the

agency is hampered by a slow-moving culture and political influences

from the White House.

 

The agency has already implemented some reforms recommended by the

Institute of Medicine and other groups in the wake of safety problems

with Vioxx and other drugs. In 2005 it created a new advisory board

to help oversee drug safety problems.

 

Von Eschenbach says the FDA will soon launch the " Sentinel

Initiative, " an effort to form a national computer network that

allows researchers to more easily study drug safety problems.

 

" Anything that improves the agency's moribund tracking of adverse

events is fine, " says Peter Lurie, MD, deputy director of Public

Citizen's Health Research Group. " The real question is whether or not

the agency pays attention to the signals. "

 

" It's a de facto admission that [von Eschenbach] should have asked

for these resources the moment he came into office, " Lurie tells

WebMD.

 

Von Eschenbach also announced the agency is in talks designed to put

FDA field offices in place in China and India. He said the effort

would extend to Central and South America as well and Europe.

View Article Sources

SOURCES:

 

Andrew von Eschenbach, MD, Commissioner, FDA.

 

Peter Lurie, MD, deputy director, Public Citizen's Health Research

Group.

 

 

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