Heparin imported from China kills 18 people. Baxter International is the maker of the tainted Heparin. Baxter received a letter from the F.D.A warning about the Chinese plant identified as the source of contamination stating the plant had unclean tanks to make heparin, accepted raw materials from undependable vendors and did not have adequate ways to remove impurities. F.D.A. has discovered cheap fake additives to heparin in 2006. Poor inspections of plants have been acknowledged by the Bush administration and plans have been made to improve the situation. One cause of this crisis appears to be budget cuts to the F.D.A. that has caused a backlog in inspectors. F.D.A. would need decades to complete inspection of every foreign plant. The 1938 law “The Food, Drug, and Cosmetic Act” enacted following the deaths of more than 100 people caused by ingestion of a solvent-laced antibiotic. The cut down on chances of another tragedy Congress passed the law requiring all new drugs undergo testing for toxicity. This law should have prevented the heparin tragedy but without enough F.D.A. staff to test drugs and inspect factories the heparin got on to the market and caused deaths.
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Forensic Nursing Chronicles 