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US Health Official Plans for Drug Inspectors in China

PharmaManufacturing.com
04/16/2008

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 of the massive amounts of 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.

Leavitt said the U.S expects to build a presence in a number of other countries, including India and those of the Central American region. He said the safety of food and product imports is "a global problem" driven by a rapid increase in goods being produced and consumed across borders.

"We've started a conversation with the Indian government but no conclusions have been reached," he said, adding that the amount of pharmaceutical trade between the United States and India has grown rapidly and that there are now up to 100 FDA-inspected facilities in India.

"Many of the products that are innovations of American science and American pharmaceutical companies are now being produced in India," he said. "So that requires us to be where products are being developed and being produced."