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Chinese pharma plants go un-inspected?
February 15, 2008

Recently Baxter International has taken it on the chin with product recalls over patient reaction problems with its blood thinner heparin. With product contamination under investigation as a possible cause, a very strange story about sourcing active ingredients in China has emerged.

According to an account in the Chicago Tribune, the company that supplies the AI to Baxter farms it out to a partner producer in China. It turns out that China is the largest producer of AIs for pharmaceuticals, but the U.S. FDA doesn't seem to spend much time there doing plant inspections. According to federal government statistics, the FDA performed 11 plant inspections in China in 2007, compared to 61 in India, 24 in France, and 18 in Germany.

Baxter inspectors have been to the plant that produces the AI in question, but the FDA never has. Apparently all of this has been done above board following correct procedures so there is no obvious wrongdoing. The plant in question was fully authorized to make the product. The FDA makes its own decisions as to what plants to check.

The whole situation gets murky around inspection cooperation between China and U.S. There are programs in the works to try and work through procedures, data collection, and the like, but progress is frequently bogged down. Of course all these exist in the context of additional problems within the FDA. Investigations going on in the U.S. Senate found that the FDA budgets a mere $3.5 million to pay for all foreign inspections. Think about that the next time you take a pill.

Posted by Peter Welander on February 15, 2008 | Comments (2)