Regulatory Focus™ > News Articles > FDA: China Still Withholding Promised Visas Meant to Bolster Inspectional Capacity

FDA: China Still Withholding Promised Visas Meant to Bolster Inspectional Capacity

Posted 24 February 2014 | By Alexander Gaffney, RAC

Late last year, US officials announced what they said was a breakthrough for the US Food and Drug Administration's (FDA) efforts to ramp up its inspection presence in China-a region with increasing pharmaceutical exports to the US.

Background

Under the terms of the December 2013 agreement between White House and Chinese officials, China was set to allow a "substantial increase in the number of US food and drug inspectors stationed in China," according to a White House statement. The move followed FDA's unsuccessful attempts to obtain visas for its staffers to work on a long-term basis in the country under funding made available to it under the Food and Drug Administration Safety and Innovation Act (FDASIA).

As Focus reported at the time, the increased staffing levels were seen as portending an increase in scrutiny and Warning Letters in a region that has sometimes been outright hostile to FDA.

There's just one problem: Months later, those visas still haven't been given to FDA.

Delays Hinder Inspections

News of the ongoing delays first surfaced in a February 2014 New York Times article. China has "so far failed to provide the necessary visas despite [the] announced agreement," the Times explained, referencing an interview with a top FDA press official.

In subsequent comments to Focus, FDA press official Christopher Kelly did not deny the lack of visas, but said FDA has still been able to maintain a presence in China.

"In China, we have 13 staff posted in three locations: Beijing, Shanghai and Guangzhou," Kelly wrote. "This includes eight U.S. civil servants and five Chinese staff." The agency also has two inspectors stationed in Shanghai, he added.

But that's a far cry from the 10 additional drug inspectors set to be stationed in Beijing once FDA's China operations are fully staffed.

In the meantime, FDA has been forced to expend additional resources using a "short-term trip" approach that requires its inspectors to fly out to the country each time they wish to conduct an inspection, Kelly said.

Despite this approach, FDA has "dramatically increased" the number of inspections it conducts in China since 2008, Kelly added.


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