China Agency Accuses US of Shoddy Heparin Investigation

Baxter International Inc. and the FDA have accused Chinese suppliers of contaminating shipments of the drug , and now the Chinese investigators claim that the U.S. is not sharing pertinent medical information. From Newsday:

China’s agency accused the United States on Tuesday of stonewalling Beijing’s investigation into a blood thinner linked to 81 deaths by refusing to provide details on victims and specifics about the later stages of drug production.

Two Chinese experts who attended a conference on the drug, heparin, in suburban Washington, D.C., last month said the U.S. determined a contaminant was likely to blame without considering other possible factors.

The U.S. Food and Drug Administration said it suspects the problems stem from a contaminant the agency discovered in supplies of raw heparin coming from China – a compound derived from animal cartilage that so closely mimics heparin that routine purity tests can’t detect it.

The FDA did not immediately respond to China’s concerns.

However, Chinese officials have apparently not responded to an Establishment Inspection Report from the FDA on April 21. The FDA’s letter claimed that a major heparin manufacturing plant in Wujin city could not ensure either the quality of the drugs produced or the ability to accurately test for drug impurities. The FDA ordered the facility to replace equipment and revise manufacturing practices.

. . .We have completed our review of the Establishment Inspection Report (EIR) for the
inspection conducted at your active pharmaceutical ingredient manufacturing facility in
Wujin City, Changzhou, China by U.S. Food and Drug Administration (“FDA”) ,
Investigator Regina T. Brown and Chemist Zi Qiang Gu on 20-26 February 2008. The
inspection revealed significant deviations from U.S. Current Good Manufacturing Practice
(CGMP) in the manufacture of active pharmaceutical ingredients (API). These deviations
were listed on an Inspectional Observations form (FDA-483) issued to you at the close of
the inspection. . .

The Chicago Tribune also published an article on how Baxter International is managing the liability issues surrounding heparin. Baxter International, in a meeting with shareholders, blamed rural Chinese suppliers for the contaminated heparin.

Baxter International Inc. has yet to experience significant legal costs in dealing with potential liability surrounding problems with the recalled blood thinner heparin, company chairman Robert Parkinson told Baxter shareholders this morning.

Although the bulk of the meeting was without controversy, focusing on Baxter’s financial performance of record sales last year, much of the discussion during a 15-minute question period dealt with the heparin controversy. Another shareholder wondered if Baxter has taken steps to “close the loopholes” in its supply chain to make sure such a situation did not happen again.



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