FDA's China office opens next month

FDA watchdogs will move into China next month, HHS Secretary Mike Leavitt said. The agency's Chinese office signals a new approach toward food and drug safety, he said; it's too tough to try to catch unsafe products [1] at the U.S. border. "[W]e're changing our strategy... to building safety into the products," he said.

Heading up the China office will be Christopher Hickey, currently director of HHS' Asia and Pacific office. Though FDA staff will start working there next month, the office won't officially be open till October. According to previous reports, the agency plans to establish eight FDA positions at U.S. diplomatic posts in China and to hire five Chinese employees in key cities.

The new office, of course, is a response to a string of contaminated products coming out of China. Most recently, tainted heparin [2] whose active ingredient was made in China forced a massive recall; the drug has been linked to 62 deaths and hundreds of allergic reactions. The new office also affirms the current realities of the drug industry: About 40 percent of drugs and 80 percent of their ingredients are imported, a growing number from countries such as China and India, where drug-safety controls are new. Leavitt said the U.S. plans to build a presence in other countries besides China, such as India and Central America.

- read the Associated Press story [3]
- see the article [4] in the Wall Street Journal

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