andrew schneider investigates

February 19, 2008

FDA inspects wrong drug factory

Filed under: FDA,Public health legislation — Andrew Schneider @ 09:38

We know that the Food and Drug Administration is having a hard time inspecting imported food for safety, but Washington Post reporter Marc Kaufman provides an alarming view of the agency’s difficulties in protecting the quality and safety of medication.

He writes that FDA knew that more than 350 recent adverse reactions to the drug heparin have been reported , including a dangerous lowering of blood pressure, breathing difficulties and vomiting. Four patients who took the drug died. But when the FDA approved the Chinese company that produced key ingredients in the medication, it evaluated the safety and quality reports on the wrong factory.

The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden spike in serious problems with the drug, which has been on the market since the 1930s.


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