(Saint Petersburg, FL - July 20, 2011)

The US Government is expanding its investigation into contaminated heparin from China into the United States market. The US has been working with 10 pharmaceutical companies to see how the contaminated active ingredient got into the US supply chain.

Heparin contaminated with overly sulfated chondroitin sulfate was linked to adverse reactions and the deaths of dozens of patients. FDA has actually determined that the contaminant was introduced on purpose, but neither the source of the contaminant nor those responsible has ever been officially identified.

More than 80% of the U.S. heparin supply is sourced from China. As part of the US government's conclusions thus far, all or some of the individuals responsible for the contaminated products are still involved in the Chinese pharmaceutical supply chain. According to Jonathan Lewis, a FDA expert that specializes in pharmaceutical supplier (vendor) quality and Principal at Advanced Biomedical Consulting (ABC), LLC, "These contaminated products and others circulating in the pharmaceutical supply chain pose a significant risk to pharmaceutical products imported into the U.S."

The U.S. Government Accountability Office also blamed some of the FDA's efforts associated with the continuance of allowing drugs to be imported from Chinese manufacturers that refused US inspections.

 (Saint Petersburg, FL - July 20, 2011)