The Chinese plant that supplied Baxter with raw heparin is registered with the Chinese government as a chemicals company, exempting it from inspection by domestic officials who only check out heparin makers registered as pharmaceuticals firms. That loophole--and many others in the supply chain linking pigs in China to vials of heparin on hospital shelves--are coming under fire as regulators probe hundreds of adverse reactions to Baxter's heparin, the Wall Street Journal reports. Some companies along the Chinese heparin chain have been cited for environmental problems, including worms on the floor of one processing facility.
Meanwhile, the Chicago Tribune reports that Baxter doesn't closely monitor its supply chain, so it did not know that the Chinese plant providing bulk ingredients for its medication had never been inspected by Chinese or U.S. regulators. "It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier," CEO Robert Parkinson told the newspaper.
As you know, Baxter first recalled numerous lots of its heparin products, then last week stopped making them. FDA inspectors have traveled to China to check out the plant that may be linked to the adverse reactions. Four patients given the drug died, though it's unclear whether the heparin was the cause of death.
Meanwhile, some rival drug makers could benefit if docs substitute their blood-thinning meds for heparin: Sanofi-Aventis and its Lovenox med, a "low molecular weight heparin"; Pfizer's Fragmin, another low-molecular-weight version of the drug; GlaxoSmithKline's Arixtra, an anti-clotting drug used in specific surgeries and other situations; and other products from GSK, Bayer, and Medicines Co.
Baxter tests point to Chinese problem. Report
FDA inspected wrong Chinese plant. Report
Congressman: FDA chief should resign. Report
Chinese plant linked to recalled heparin. Report
Baxter stops making multidose heparin. Report
Baxter recalls heparin on adverse events. Report