【drug-news】FDA改革：并非奥巴马首选政要
发布于 2008-12-23 · 浏览 1042 · IP 浙江浙江
这个帖子发布于 16 年零 97 天前，其中的信息可能已发生改变或有所发展。
FDA reform likely to take back seat in Obama plan
Despite push for legislation, 'dysfunctional' agency overshadowed
By Noam Levey | Tribune Washington Bureau
December 22, 2008
After years of food poisoning episodes, tainted imports and unrealized promises of reform, the incoming Obama administration has been saying the embattled Food and Drug Administration would finally get what it needed to make the nation's food supply safer.
But now, some of the leading champions of rebuilding the FDA and the food safety system acknowledge that big reforms are likely still years away.
"This is an issue that will have to wait its turn," said Assistant Senate Majority Leader Richard J. Durbin, a Democrat from Illinois and longtime proponent of tougher food laws and a friend of President-elect Obama.
Once again, bigger problems with higher profiles might shoulder aside food safety in the competition for resources. With the federal deficit already in record territory, the new administration committed to nearly $1 trillion in new economic stimuli - on top of billions for financial and other bailouts - and expensive domestic initiatives promised for such problems as healthcare and global warming, more money for food safety may be hard to come by.
And instead of assuming more direct control of the inspection system, the government seems likely to remain heavily dependent on growers, food processors and others in the industry to police themselves and the food supply.
Durbin and others on Capitol Hill nonetheless plan to push ahead with legislation to try to strengthen the FDA, the much maligned agency responsible for overseeing about 80 percent of the food Americans eat. While most meat and dairy products are regulated by the U.S. Dept. of Agriculture, fresh produce and most processed foods are the responsibility of the FDA.
Obama, who has backed Durbin's efforts and sponsored his own legislation to strengthen state and local food oversight, will continue to back them, according to an official working on his transition.
The federal government's food oversight was once seen as a model. But after years of neglect - and Bush administration distaste for aggressive government regulation - a series of deadly food-borne disease outbreaks involving peanut butter, spinach and peppers called public attention to gaping holes in the FDA's capacity to stay on top of a rapidly expanding market.
The agency struggled to identify the sources of contaminated foods, most recently this spring when federal officials initially linked a salmonella outbreak to tomatoes before concluding that jalapeno peppers from Mexico were the likely culprit.
At the same time, contaminated pet food from China exposed weaknesses in the agency's system for regulating imports. Consumer groups lambasted the agency for failing to protect the public; food-borne illnesses sicken as many as 76 million people and kill an estimated 5,000 each year.
Growers complained that the FDA's failure to identify the source of contaminated food quickly intensified public fears. That, in turn, severely hurt the market for products like leafy greens and tomatoes.
"The spinach industry has never recovered," said Tom Nassif, who heads the Western Growers Association, a leading national trade group based in California.
Independent reviews by the Government Accountability Office and others found the agency lacked even basic information technology capabilities to analyze data and assess risks.
"We need some radical shifts," Dr. David Acheson, FDA's associate commissioner for foods, acknowledged in a recent interview.
A year ago, the FDA announced its own plan for reform, promising a major expansion of overseas inspections, better systems to identify where risks are highest and more cooperation with state and local authorities as well as industry.
The agency opened an office in China this year and plans to open ones in India and Latin America in 2009. But the promised changes have not come soon enough for critics, including many on Capitol Hill. "There is little question that the FDA is dysfunctional," said Democratic Rep. Rosa DeLauro of Connecticut, who has pushed for a more sweeping overhaul of the agency. "The current structure is incapable of addressing food safety problems."
Despite push for legislation, 'dysfunctional' agency overshadowed
By Noam Levey | Tribune Washington Bureau
December 22, 2008
After years of food poisoning episodes, tainted imports and unrealized promises of reform, the incoming Obama administration has been saying the embattled Food and Drug Administration would finally get what it needed to make the nation's food supply safer.
But now, some of the leading champions of rebuilding the FDA and the food safety system acknowledge that big reforms are likely still years away.
"This is an issue that will have to wait its turn," said Assistant Senate Majority Leader Richard J. Durbin, a Democrat from Illinois and longtime proponent of tougher food laws and a friend of President-elect Obama.
Once again, bigger problems with higher profiles might shoulder aside food safety in the competition for resources. With the federal deficit already in record territory, the new administration committed to nearly $1 trillion in new economic stimuli - on top of billions for financial and other bailouts - and expensive domestic initiatives promised for such problems as healthcare and global warming, more money for food safety may be hard to come by.
And instead of assuming more direct control of the inspection system, the government seems likely to remain heavily dependent on growers, food processors and others in the industry to police themselves and the food supply.
Durbin and others on Capitol Hill nonetheless plan to push ahead with legislation to try to strengthen the FDA, the much maligned agency responsible for overseeing about 80 percent of the food Americans eat. While most meat and dairy products are regulated by the U.S. Dept. of Agriculture, fresh produce and most processed foods are the responsibility of the FDA.
Obama, who has backed Durbin's efforts and sponsored his own legislation to strengthen state and local food oversight, will continue to back them, according to an official working on his transition.
The federal government's food oversight was once seen as a model. But after years of neglect - and Bush administration distaste for aggressive government regulation - a series of deadly food-borne disease outbreaks involving peanut butter, spinach and peppers called public attention to gaping holes in the FDA's capacity to stay on top of a rapidly expanding market.
The agency struggled to identify the sources of contaminated foods, most recently this spring when federal officials initially linked a salmonella outbreak to tomatoes before concluding that jalapeno peppers from Mexico were the likely culprit.
At the same time, contaminated pet food from China exposed weaknesses in the agency's system for regulating imports. Consumer groups lambasted the agency for failing to protect the public; food-borne illnesses sicken as many as 76 million people and kill an estimated 5,000 each year.
Growers complained that the FDA's failure to identify the source of contaminated food quickly intensified public fears. That, in turn, severely hurt the market for products like leafy greens and tomatoes.
"The spinach industry has never recovered," said Tom Nassif, who heads the Western Growers Association, a leading national trade group based in California.
Independent reviews by the Government Accountability Office and others found the agency lacked even basic information technology capabilities to analyze data and assess risks.
"We need some radical shifts," Dr. David Acheson, FDA's associate commissioner for foods, acknowledged in a recent interview.
A year ago, the FDA announced its own plan for reform, promising a major expansion of overseas inspections, better systems to identify where risks are highest and more cooperation with state and local authorities as well as industry.
The agency opened an office in China this year and plans to open ones in India and Latin America in 2009. But the promised changes have not come soon enough for critics, including many on Capitol Hill. "There is little question that the FDA is dysfunctional," said Democratic Rep. Rosa DeLauro of Connecticut, who has pushed for a more sweeping overhaul of the agency. "The current structure is incapable of addressing food safety problems."
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