FDA Does Not Inspect Chinese Drug Manufacturer Due To Mix-up

Greg Webb

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The Food and Drug Administration (FDA) failed to inspect a Chinese facility that supplies the active ingredient of heparin, a widely used blood thinner, because the facility's name was confused with another just like it. The FDA says, however, that the heparin case is one of their top priorities and a team of inspectors is on its way to investigate the plant as part of an effort to deduce what caused the sudden spike of problems with the drug, which has been on the market since the 1930's. There were 350 adverse reactions to the drug, including vomiting, breathing difficulties, low blood pressure, and death in four cases. Last week, the FDA advised doctors to start prescribing alternatives to heparin. While federal law does not require the FDA to inspect foreign drug manufacturers, the agency usually does perform inspections before allowing a new drug or ingredient to go to American consumers with an FDA stamp of approval.

This error has given further evidence of the FDA's shortcomings. The agency seems uncertain about the number of foreign drug companies due to conflicting databases; one database says there are 7,000 foreign drug companies while another says there are only 3,000. The FDA commissioner is asking the government to agree to posting FDA inspectors in China, India, the Middle East, and three other regions. He also wants the FDA to have a permanent presence in the U.S. embassy in Beijing.