International Law

FDA Comes to China

By Stan

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. (AP story is here.)

Eight locations? That’s more than I expected. It will be really interesting to see how this whole thing unfolds. As a lawyer working in a multinational firm, I think there are certainly going to be opportunities for multi-jurisdictional service providers to help U.S. firms with local China-based manufacturing facilities that will be the subject of inspections. That’s my first, admittedly self-serving, reaction.

Big question for me is whether there will be adequate resources available to FDA to actually do whatever it is they are supposed to be doing here. It’s no secret that the capabilities of U.S. regulatory agencies have been degraded quite a bit during the Bush Administration. I assume that the funding for this has been made available by Congress - will the FDA pick up the ball and run with it?

Full post as published by China Hearsay on April 16, 2008 (boomark / email).