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FDA To Post Inspectors In Developing Nations

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The New York Times

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 medicine increasingly flowing to the United States, a top official said Thursday.

The agency's commissioner, Andrew von Eschenbach, said that he wanted to have "boots on the ground" in nations such as India and China and regions such as Central and South America and the Middle East.

The agency already sends inspectors to dozens of countries each year to scrutinize pharmaceutical plants and clinical trial sites, but von Eschenbach said he wants the agency's presence abroad to be on an "ongoing and continuous basis rather than episodic and periodic."

The inspectors would primarily "build capacity and bring others in to do inspections that are certified," 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 FDA.

As recently as 1999, health regulators in Canada and Australia did not have the authority to inspect clinical trial sites, said David Lepay, a senior adviser for clinical science at the agency.

In recent years, as more food and drugs have been produced abroad for sale in America, the FDA has been less able to ensure the products' safety. The agency inspects less than 1 percent of imported food.

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