Margaret Hamburg, the Commissioner for Food and Drug Administration will push Chinese officials to grant visas for more inspectors in a visit to China next week, part of an effort to make sure food and medicine made abroad is safe for Americans; who said hopefully, “We have every reason to believe that we will be getting the visas very shortly.”
It’s not clear what makes her think what if anything has shifted the Chinese government from continuing it’s stand to stall granting visas to inspectors, just as they have done so for years. The F.D.A. first pushed to expand its presence there and opened an office there to do its own inspections after Chinese-made crude heparin was tied to 246 deaths of dialysis patients in 2008.
FDA last year got additional funds to expand its operations there ($10 million), but China has been sitting on visa applications for the extra FDA inspectors; which is particularly worrying as China ranks seventh among countries that export drugs to the United States, and sixth among food exporters to the United States.
Would you like to guess how many F.D.A. inspectors the United States has posted in China today?
You’ll never guess, because the number is so absurdly low, it might be laughable if it wasn’t so truly tragic.
The answer: Eight inspectors. The hope is that the F.D.A. will be able to expand its presence in China to 26 American staff members from eight.
Imagine….you’ve been given one of the most important jobs in the world: You are one of those lucky few who were chosen to be posted to China as an inspector for the United States Food and Drug Administration.
After packing up you life in the States, fully prepared to fulfill your duties, there was an aspect of the job you had not prepared for: Loneliness.
The welcome party was the first tip-off something was not all as it should be. What struck you as most peculiar was that there were only seven other U.S. food safety officials there.
As you stood holding your plastic cup of champagne, you struggled to find the words that you knew would almost certainly sound absurd the moment they left your lips: “Is this it? I mean, is this all there is? Just us eight people?”
“Yup, that’s right – it’s just us.”
Christopher Hickey, director of the F.D.A.’s China operation, said that it had filled the gaps by bringing in experts temporarily, but that short-term workers often lack deep knowledge of trends that years in the country provide.
As China becomes a bigger player in U.S. markets, the F.D.A plans to more thoroughly examine the safety and effectiveness of its products, and factories where they are made, but how the FDA plans to realistically accomplish such a goal despite having only a skeleton crew of F.D.A. officials posted in China is impossible to comprehend.
Examinations when they do occur, has been proven difficult when the F.D.A last summer banned products from Beijing Shunxin Meihua Bio-technical after its employees refused to let U.S. inspectors see its entire plant or go over some of the required paperwork. The F.D.A also discovered it had bought supplies from a company whose ingredients were suspect. Testing determined some of Beijing Shunxin’s products were tainted.
A similar incident occurred when U.S. inspectors were told by Chinese officials they could not take samples of chicken jerky to the U.S. for testing following the illness and death of hundreds of dogs who consumed the treats. That refusal essentially gave the F.D.A the opportunity to refuse imports of those products, instead, for reasons we will never comprehend, the FDA decided to allow the products to continue to be imported and sold in the U.S. — allowing more innocent animals to be exposed to some unknown toxin.
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