More Woes for the FDA Over Heparin - KCBD NewsChannel 11 Lubbock

4/22/08

More Woes for the FDA Over Heparin

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In light of recent questions surrounding contamination of the blood thinner Heparin, lawmakers met on Capitol Hill Tuesday to look at how the FDA can fix internal problems. 

Some Heparin products were recalled after it was linked to 81 deaths and hundreds of severe allergic reactions.  The contaminant has since been traced to 12 different Chinese companies that supply its active ingredients.

Bart Stupak, a Democratic Representative from Michigan, says, "In China, one of the largest producers of active pharmaceutical ingredients for the U.S. market, FDA only inspects about 10-20 firms each year, against an inventory of more than 700 firms. At this rate, the FDA can only inspect each Chinese firm about once every 30 to 40 years."

The FDA argues that the contaminant was found after the agency switched to highly sensitive testing that is not used in routine inspections.  So, in a situation like that, simply increasing the number of inspections would not have revealed the Heparin scare.

Instead, the US Government Accountability Office estimates it would take 67 million dollars each year to inspect the more than 3,000 plants around the world that supply drugs to the US- and that's about 50 million more than what the government has budgeted.

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