F.D.A. Plans to Post Inspectors Overseas
FDA의 Dr. Andrew C. von Eschenbach 는 미국으로 반입되는 식품, 의약품의 품질을 향상시키기 위해서 India, China, Central and South America, Middle East 등의 지역에 미국 대사관과 상주 검사관을 지속적으로 파견하는 작업을 추진하겠다고 밝혔다.
By GARDINER HARRIS
Published:
January 25, 2008
WASHINGTON — The Food and Drug Administration intends to post inspectors to embassies and consulates throughout the developing world in hopes of improving the quality of the food and medicines increasingly flowing to the United States, a top official said Thursday.
The agency’s commissioner, Dr. Andrew C. von Eschenbach, said that he wanted to have “boots on the ground” in nations like India and China and regions like Central and South America and the Middle East.
The agency already sends inspectors to dozens of countries each year to inspect pharmaceutical plants and clinical trial sites. But Dr. von Eschenbach said in a briefing with reporters that he wanted the agency’s presence abroad to be on an “ongoing and continuous basis rather than episodic and periodic.”
“Right now, we come, we leave,” he said.
The inspectors would primarily “build capacity and bring others in to do inspections that are certified,” Dr. von Eschenbach said.
The agency has long helped to train foreign food and drug inspectors and even advise in the writing of legislation to empower foreign versions of the F.D.A.
As recently as 1996 in Canada and 1999 in Australia, health regulators did not have the authority to inspect clinical trial sites, said Dr. David Lepay, a senior adviser for clinical science at the agency.
“So much of our work has been trying to get authorities who can do something legally in their own countries to develop laws and regulations and put them in place operationally,” he said.
In recent years, as more food and drugs have been produced abroad for sale in America, the F.D.A. has been less able to ensure the products’ safety. The agency inspects less than 1 percent of imported foods.
Some on Capitol Hill have called for a large increase in the agency’s budget to improve such inspections. The Bush administration, however, has not endorsed those calls. Instead, F.D.A. officials have sought to bolster the aggressiveness and effectiveness of foreign health regulators, hoping to prevent unsafe items from being brought to American docks in the first place.
Dr. von Eschenbach said that his plan to post inspectors abroad was still in its infancy. He was not sure whether he would ask for additional financing from Congress for the inspectors or find money in his present budget for them, he said.
He also said that he had yet to work out with the State Department how such inspectors might interact with other parts of the federal government. In addition, host nations would have to request their presence, he said.
In December, the United States and China agreed to a greater American role in certifying and inspecting Chinese food products, including an increased presence of American officials at Chinese production plants.
*발췌: 뉴욕타임즈
http://www.nytimes.com/2008/01/25/business/25fda.html?_r=1&oref=slogin
