It was a glitch. That's what the FDA said last week when confronted with the news that it hadn't inspected the Chinese plant that made the main ingredient for Baxter's recalled batches of heparin. Now we know just how big that glitch was: The FDA inspected and approved the wrong plant. No wonder some in the blogosphere are calling it the "Fundamentally Defective Agency."
When the company that makes that active ingredient applied for FDA approval, the agency thought the app had come from a similarly named company whose plant had already been checked out. No new inspection--until now, after a big spike in adverse reactions to the med. Four patients who took it died, and Baxter stopped selling the product.
Chinese watchdogs don't even try to inspect plants that make drugs solely for export. So not only this plant fell through those particular regulatory cracks, but every plant that, like it, only exports its products. And as all sorts of audits have shown, FDA has an enormous blind spot in Asia, where scant numbers of manufacturing facilities have seen agency inspectors.
One bright spot in this big heparin mix-up is the fact that Baxter's leading heparin rival APP Pharmaceuticals is quickly picking up new customers. The company is ramping up production to deal with the increased demand.
- read the report about FDA's mix-up in the Washington Post
- check out the Chinese inspection angle in the Chicago Tribune
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