Is China Blocking FDA Inspectors?

In late 2012 the U.S. Food and Drug Administration asked the Chinese government about the possibility of stationing 20 inspectors in China to supplement the nine staff it already had there at the time. The request wasn't unreasonable. “The crucial ingredients for nearly all antibiotics, steroids and many other lifesaving drugs are now made exclusively in China,” noted the New York Times on Feb. 14. Yet, despite the ever-increasing volumes of exported drugs and food from China to the United States, and a mid-December 2013 agreement with the Chinese government personally brokered in Beijing by U.S. Vice President Joseph Biden, most of those added inspectors are still in the United States, awaiting visas.

FDA spokesperson Christopher Kelley declined to comment on the issuance of the visas, nor why they might have been delayed. In a Feb. 21 email, however, he noted that the FDA has 13 staff members currently based in China and the agency “continues to use its existing in-country staff and inspectors on short-term trips from the United States to ensure the safety of FDA-regulated products from China.”

Though no fault of the FDA, that’s simply not good enough. Of the 278,307 foreign food facilities registered by the FDA, 26,743 are located in China, according to Food Safety News. And those facilities export a lot: Between 2003 and 2012, Chinese exports to the U.S. grew from 2.3 billion to 4.1 billion tons.

According to a Bloomberg News report from December, the FDA can perform 20 to 25 food-related inspections per year in China at current staffing levels. The new staff -– there are to be ten drug and seven food inspectors -- would increase that number to 160, with pharmaceutical inspections receiving a similar boost. That’s a big (if hardly sufficient) improvement.

In December, Christopher Hickey, the director of the FDA’s office in Beijing, told Bloomberg News that the Chinese government had opposed visas for five FDA inspectors intended for China, and conceded that the U.S. didn't know the “full story” as to why. It’s possible that Chinese officials are keenly aware that China remains a major hub for drug counterfeiting and are reluctant to open up their factories to scrutiny. Indeed, the current FDA office in China was opened after a counterfeit blood thinner manufactured in China-caused dozens of deaths and hundreds of injuries in the States.

Chinese newspapers are filled almost weekly with stories of contaminated and counterfeit food; U.S. inspectors probably wouldn't have much trouble uncovering additional cases. Nonetheless, far from being a threat, the added inspectors should be viewed as an opportunity for China's best manufacturers and food producers to earn approval -– quickly –- for the entry of their products into the U.S. market. FDA approval remains the global pharmaceutical gold standard, and the benefits of earning it aren't confined to the U.S. market alone.

Of course, it’s never comfortable to be subjected to foreign inspectors on your own soil. But long-term it’s surely worth the trouble, if only to avoid antagonizing U.S. consumers, and a U.S. Congress increasingly suspicious of China’s commitment to food and drug safety. Approving the FDA visas will benefit both countries, and it’s time that China makes good on its promise to do so.