Top U.S. Drug Official to Push for More Inspectors in China

The top U.S. pharmaceutical regulator will push Chinese officials to grant visas for inspectors in a visit to China next week, part of an effort to make sure food and medicine made abroad is safe for Americans.

The Chinese government has stalled granting visas to Food and Drug Administration inspectors since at least 2012. The FDA first pushed to expand its presence there after a tainted blood-thinning drug was linked to 246 deaths in the U.S.

FDA Commissioner Margaret Hamburg said she hopes to make progress on the visas while in China from Nov. 17-21, when she will meet with international regulators. Despite a commitment between U.S. Vice President Joe Biden and the Chinese government last year to allow more FDA workers, the visas haven’t materialized.

“We’re heading into the home stretch,” Hamburg said today during a call with reporters. “We have every reason to believe that we will be getting the visas very shortly.”

The FDA opened its China office in November 2008, following a recall in the U.S. of the blood-thinning medicine heparin. The recalled heparin was made with a fake Chinese active ingredient, and linked to 246 deaths from Jan. 1, 2007, to May 31, 2008. In another incident, tainted jerky from China sickened thousands of Americans’ pet dogs.

The agency wants to increase the number of U.S. inspection workers in China to 26 from eight, Christopher Hickey, director of the FDA’s China office, said on the call. Ten new hires will inspect drug manufacturing plants, seven will inspect food firms and one will be a management position, he said.

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