At least19 people have died, and hundreds became ill after being given heparin, a blood-thinning drug sold by drug manufacturer Baxter International. Baxter obtained the drug’s active ingredient from a Chinese manufacturer.
A belated inspection of the Chinese plant found substandard conditions. Recent lab tests revealed an unknown contaminant in batches of the drug, but researchers have not identified what precisely caused the allergic reactions which caused the deaths.
The Food and Drug Administration is required to inspect plants such as the one in China which supplied the heparin ingredient. However, under the Bush Administration, it has failed to follow this mandate.
Currently, 80 percent of all active drug ingredients come from abroad, but the FDA doesn’t know what percentage of foreign manufacturing facilities it has inspected. Many of these plants are in developing countries that don’t have infrastructure that meets U.S. safety standards.
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