Chinese regulators failed to regulate chemicals, which resulted in contaminated Heparin reaching patients

A U.S. commerce official said that China did not have the ability or will to regulate its economy properly, allowing the export of a chemical that contaminated the blood-thinner Heparin, which is suspected of killing dozens, according to a Reuters article on April 25, 2008.

The official said the United States was concerned Chinese regulators did not have the authority to monitor both pharmaceuticals and bulk chemicals.

Reportedly, the State Food and Drug Administration lacked the authority to regulate both the makers of active pharmaceutical ingredients and those that make bulk chemicals, which may be used in pharmaceuticals but are not considered to be of medicinal use.

The FDA has identified 12 Chinese companies that have supplied Heparin to 11 countries, including the US. The death toll here associated with the defective drug is 81.

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