点击显示 收起
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.
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.