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9 Dec 2013

China Finally Allows FDA To Add Inspectors

Pharmalot's Ed Silverman reported that after a year of frustration and delay, the White House has finally reached agreement with the Chinese government to allow FDA to boost its inspection team as part of a plan to bolster oversight the pharmaceutical supply chain. As a result, the agency will add another 10 drug inspectors to its existing staff of one.


The delay had been a setback to FDA efforts to improve oversight and assert its authority — an issue that has haunted the agency ever since contaminated heparin made in China was linked to 81 deaths in the US in 2007 and 2008. The episode sparked a firestorm of criticism of the FDA for its failure to monitor medicines made there.


As noted previously, the US State Department notified the Chinese Ministry of Foreign Affairs last fall about obtaining visas for additional inspectors — a move made possible by an extra $10 million in FDA funding. But since January, the agency has waited for visas and the agency publicly acknowledged frustration this past summer at the lack of progress.


FDA actually began talking with Chinese regulators about expanding its staff in February 2012, but until now, the agency has only been able to send investigators who are permitted to make short-term trips to conduct inspections. One FDA staffer, meanwhile, withdrew his application for a visa last April after waiting 9 months for diplomatic approval to work in China.

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