Whoops!
by dday
Here’s a little more on that e.coli conservatism I was talking about. In this case it’s the FDA, apparently indistinguishable from the Keystone Kops.
The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and Drug Administration because the agency confused its name with another just like it, agency officials said yesterday […]
Joseph Famulare, deputy director for compliance at the FDA’s center for drug evaluation and research, said yesterday in a conference call with reporters that when the company that makes the active ingredient for heparin applied for FDA approval, the FDA thought the application had come from a different company with a similar name that had already been inspected.
“To date this is an isolated situation, but the wrong firm was put into the database,” he said. Famulare declined to name the Chinese company approved by mistake.
I mean, we don’t have any Arabic speakers gathering intelligence, why would we have any Chinese speakers at the regulatory agency dealing with products from China? Not like they’re a big importer or anything.
It takes time to properly train regulators. They need to be experts in their respective fields and to know what to look for. This is a project that will take years and years after this Administration is gone. Bush has put us all at risk; that’s not hyperbole.
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