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FDA Criticized For Handling of Tainted Heparin Investigation

Apr 30, 2010 | Parker Waichman LLP

The Food & Drug Administration (FDA) is facing criticism over the way it handled a 2008 investigation into tainted heparin. The heparin, the active ingredient of which was manufactured in China, was linked to 80 deaths and hundreds of illnesses.

In January 2008, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme – and in some cases fatal – allergic reactions, after being administered the products. There were similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, the FDA ultimately initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

In March 2008, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories.

Changzhou used two consolidators to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. The FDA investigation never identified the culprits in the contamination, with the agency maintaining that there were too many sources to trace.

According to The Wall Street Journal, Rep. Joe Barton of Texas, the top Republican on the House Energy and Commerce Committee, has been looking at the FDA’s handling of the incident. In a letter to the agency, Rep. Barton complained that the FDA hasn’t followed up with the Chinese government on issues involving several companies in China.

The letter noted that the FDA faced serious difficulties when it conducts overseas investigations. For example, the agency had to probe the heparin problems heparin issues in China “mostly without the assistance of the Chinese government.” In one case, the agency even had to rely on the president of one Chinese company implicated in the scandal to translate during an inspection.

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