FDA and China at odds in Heparin Contaminations
China and the U.S. Food & Drug Administration traded barbs on whether the contaminant found in the blood thinner Heparin was the link between 81 deaths triggered by severe allergic reactions. Federal health officials insisted new tests indicate a solid link. China argued the contaminant could not be the “root cause” of the problem. Raw Heparin is derived from pig intestines, often processed by small and unregistered workshops in China. The raw ingredients from the recalled Baxter’s heparin came from a Wisconsin-based Scientific Protein Laboratories which is known to own the Chinese factory, Changzou SPL, as well as buying additional raw Heparin from other Chinese suppliers. The FDA warned Changzhou SPL that it does not have an adequate system for ensuring that the raw materials it uses are free from any impurities. However, agency officials are still unsure at what point the deadly contaminant was introduced. The FDA also noted that as many as 12 companies in China are involved in the supply chain for Heparin. Hundreds of patients have suffered severe allergic reactions to the doses of the contaminated blood thinner. In its warning letter to the Chinese company, the FDA said it will recommend disapproval of any new applications listing the company as the manufacturer of any active pharmaceutical ingredient. It cited “significant deviations” from good manufacturing processes. Germany also discovered the contaminant and recalled batches of Heparin after some patient illnesses.
