Number of U.S. FDA Inspectors in China is "Woefully Inadequate" Says USCC

By Karen Langhauser, Digital Content Manager

During an April 3rd U.S.-China Economic and Security Review Commission hearing, chairman Dennis C. Shea observed that inspecting the 4,000 Chinese plants registered to export APIs to the U.S. can be looked at as a "hopeless task" given the two full-time FDA drug inspectors staffed in China.

Formed in 2000, the USCC monitors, investigates, and reports to U.S. Congress on the national security implications of the bilateral trade and economic relationship between the United States and the People’s Republic of China. Global drug safety has become imperative considering that 80% of API manufacturers are located outside of the U.S. and foreign imports now account for 40% of finished drugs in the U.S.

Chairman Shea's observation was in response to testimony given by Dr. Christopher J. Hickey, China Country Director, U.S. FDA, during a hearing regarding China’s Healthcare Sector, Drug Safety, and the U.S.-China Trade in Medical Products.

Chairman Shea later asked the question at the forefront of drug imports: "could you give the American people assurance that drug imports coming into the U.S. in large numbers from China are safe?"

In response, Dr. Hickey noted there are obvious challenges, but that the U.S. FDA is placing primary responsibility on Chinese manufacturers and also have numerous tools in place - including border sampling and post market surveillance - to assure product safety. He noted that it is a "process" being undertaken jointly by the U.S. FDA and Chinese regulators.

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  • <p>This is an interesting position by FDA. Frankly, it appears unregulated since FDA expects the overseas generic drug market to regulate itself. I think this is an inappropriate position for FDA to espouse as this is such a large market and these drugs have the potential for serious injury or a complete lack of assistance. It would be prudent to have at least a spot check in place where an independent agency is monitoring this.</p>


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