An ongoing delay in obtaining visas from China for FDA staffers to work on a long-term basis in the country is preventing the agency from proceeding with plans to increase inspections, bolster regulatory practices and collaborate on public health strategies. One FDA staffer withdrew his application for a visa in April after waiting nine months for diplomatic approval to work in China, according to an FDA spokesman.
The spokesman says the US State Department last October formally notified the Chinese Ministry of Foreign Affairs about obtaining visas for additional inspectors, a move made possible by an extra $10 million in FDA funding. Since January, the agency has been waiting for the visas, but the FDA spokesman could not explain the hold up.
The delay is a setback to FDA efforts to improve the safety of the pharmaceutical supply chain, an issue that has been haunting the agency ever since contaminated heparin made in China was linked to 81 deaths in the US in 2007 and 2008 (back story). The episode sparked a firestorm of criticism of the FDA for its failure to monitor medicines made there (background).
The agency now has 13 staff posted in three locations – Beijing, Shanghi and Guangzhou – that is comprised of eight US civil servants and five Chinese staff. The FDA wants to use the additional $10 million to increase the number of drug inspectors in China from just one to 11, and also employ nine food inspectors compared with two presently employed.
The FDA spokesman says the agency actually began talking with Chinese regulators about expanding its staff in February 2012 and notes that inspectors based in China are better positioned to act quickly when a high priority inspection is required. But so far, the agency has been unable to send more investigators, except those who are permitted to make short-term trips to conduct inspections.
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