FDA to Open China Office This Year

-Wall Street Jornal

04/15/2008 -  The diplomatic details are still being worked out, but the FDA is likely to have a China beachhead up and running by the end of the year.

The agency is planning to put employees in place next month, and to open a full-fledged office this fall, the Secretary Health and Human Services told the Associated Press today during a visit to Singapore.

“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,” Mike Leavitt told the AP. But that’s not enough in the global era. “So we’re changing our strategy from one of trying to catch unsafe products to building safety into the products,” he said.

A wave of widely publicized problems with Chinese imports — most recently, the tainted blood thinner heparin — has created a call for closer scrutiny of products coming into this country from China.

The new office will be run by Christopher Hickey, who is now the director of the Asia and the Pacific office at HHS. The FDA has previously said it planned to establish eight permanent FDA positions in China and hire five Chinese employees in Beijing, Shanghai and Guangzhou. The agency is also in talks to build its position in India, another global drugs powerhouse, the AP notes.

Roughly 40% of pharmaceuticals and 80% of the chemical ingredients in drugs are imported, according to U.S. government statistics cited by the AP.

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