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Pfizer Expands in China Faster Than the FDA

By Jim Edwards

Updated on: December 1, 2008 / 6:00 AM EST / MoneyWatch

Pfizer CEO Jeffrey Kindler recently gave an indication of the scale of the FDA's problem in inspecting Chinese pharmaceutical plants. After recent scandals involving tainted baby formula and heparin made in Chinese factories, the FDA in late November beefed up its inspection presence behind the Great Wall. It has one office in the country, and plans two more. But Kindler told investors in his Q3 conference call that he expects Pfizer "to be in 137 cities" in China by the end of the year. His comment came as he touted Pfizer's new, more nimble research operations:

In China for example, we told you in March that we had set a goal of moving into a 126 cities by the end of this year. We achieved that goal seven months ahead of schedule, and we are now expecting to be in 137 cities in China by the end of the year. Now China has 160 cities with population above one million people. That makes each of them roughly the size of Dallas or even bigger. That should give you some sense of the opportunities that we have.

Just to keep tabs on Pfizer alone, FDA officials in China would have to visit one Pfizer facility every 2.7 days. Could they do it? No. Here's a description of the FDA's China capabilities:

U.S. staffing in Beijing, Shanghai and Guangzhou will total between nine and 12 people, U.S. officials say ... all U.S. imports -- from China and elsewhere -- will require testing and certification by independent laboratories.

FDA Commissioner Dr. Andrew C. von Eschenbach said:

The third-party certifiers will include private labs or Chinese government agencies working under the supervision and oversight of the FDA.

There's some confusion here as to whether the FDA China bureau will be focusing on food or drugs (China has had problems with both). Here's how many drug sites the FDA currently sees per year in China:

Only 80 of 714 drug establishments in China, were inspected by FDA during fiscal years 2002â€"2007.

So even if the FDA focused solely on Pfizer, it wouldn't see all the company's sites.

Pfizer's China expansion continues apace. On Nov. 7, the company announced a deal to extend its relationship with WuXi PharmaTech, a company that screens early stage compounds for the company.

Photo by Flickr user David Chartier, CC