FDA cracks down on Chinese heparin material providers
The contaminated heparin saga continues. The FDA has put 14 more Chinese suppliers that made a tainted ingredient for creating the widely used blood thinner on a watch list, and U.S. regulators are continuing their heparin probe that began after some 80 U.S. deaths were linked to 2008 supplies of the drug, The Wall Street Journal reported.
Hunting down the source of compromised heparin materials appears to be tricky business. As one FDA official told the WSJ, there are potentially hundreds of outfits in China that supply the raw material used to make the drug, and there are multiple stops in the supply chain before the treatment reaches patients.
There are now 22 suppliers of the heparin ingredient in China that have been put on what is called an import alert, which gives U.S. regulators the authority to block their shipments from entering the country, The New York Times reported. Regulators told U.S. manufacturers of the drug to avoid using raw materials from the 22 Chinese companies in the FDA's doghouse.
Yet FDA officials noted the outfits in China linked to contaminated heparin doses from 2008 are not necessarily contributing materials to U.S. manufacturers, pointing out the makers of the drug are now required to test supplies for impurities before they are shipped to customers. "The heparin supply is safe," said Deborah Autor, an FDA deputy commissioner, as quoted by the WSJ. "It's one of the most protected drugs out there."