FDA Adding New Staff in China, Increasing Collaboration with Chinese Regulators
Amid explosive growth in imports of drugs and devices from China, the Food and Drug Administration is stepping up its efforts in the country to improve safety, said Christopher Hickey, FDA China director, in a recent blog post. From 2007 to 2013, the total number of FDA-regulated shipments from China to the U.S. nearly quadrupled, said Hickey on April 17. In response, FDA is increasing its staff in China and is improving its collaborative efforts with Chinese regulators, he said.
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In testimony before the U.S.-China Economic and Security Review Commission from early April (here), Hickey said FDA has faced “several public health threats related to imports from China. For example, in 2007 “numerous deaths” were attributed to an adulterated anticoagulant drug. In 2012, Chinese companies were found to be using industrial-grade gelatin containing high levels of chromium in pharmaceutical capsules. Recalls of Chinese medical devices have risen from 11 in 2011 to 32 in 2013, he said.
In response, FDA is increasing the staff it has posted in Beijing, Shanghai and Guangzhou from the current 13 to 27. FDA has also requested $10 million in its proposed fiscal year 2015 budget specifically for activities in China, such as adding an additional nine drug inspectors to China; increasing the number of drug facilities it inspects; allowing more direct observation of FDA inspection activities by Chinese regulators; and strengthening FDA’s ability to use “informatics” tools like trend analysis, predictive modeling, and geospatial mapping.