FDA office may open in China next month

SINGAPORE — U.S. food and drug regulators will start working in China next month once Beijing gives its final approval, the top U.S. health official said Tuesday.

Health and Human Services Secretary Mike Leavitt said the Food and Drug Administration is planning to open an office in China as part of a change in strategy following product safety problems in Chinese imports that prompted several health scares and have been linked to some deaths.

"In the past, the United States and many other countries have employed a strategy of standing at the border trying to catch things that aren't safe," Leavitt said in an AP interview during a visit to Singapore.

However, he said it is impossible to inspect all the goods that enter the country.

"So we're changing our strategy from one of trying to catch unsafe products to building safety into the products," Leavitt said. "Our purpose is not just inspection, it's building capacity and maintaining relationships between regulators."

The FDA's China office will be headed by Christopher Hickey, currently director of the Asia and the Pacific office at the Department of Health and Human Services, Leavitt said.

Hickey, who was with Leavitt in Singapore, said Washington is still awaiting final approval from the Chinese government on the opening of the FDA's office there, but that the agency expected to begin work in May before the official opening of the office in October.

No further details were given, but the agency had earlier said they planned to establish eight permanent FDA positions at U.S. diplomatic posts in China. The FDA also said it would hire five Chinese employees in Beijing, Shanghai and Guangzhou.

U.S. regulators have recalled a number of contaminated products made in China: toothpaste, pet food, the blood thinner heparin and others. Heparin, a commonly used blood thinner, has been linked to 62 deaths and hundreds of allergic reactions in the U.S. and Germany.

About 40 percent of pharmaceuticals and 80 percent of the chemical ingredients in drugs are imported, according to U.S. government statistics. A growing share comes from developing countries such as China, India and Mexico that are still building their own drug safety systems.