GMPs, generics and repackaging drive recalls

It's not just careless inattention to manufacturing. It turns out that drug repackaging, the generics rush and a more attentive FDA that led to "a record high 1,742 drug recalls in 2009," says Health Reform Watch. That's a jump from 426 in 2008.

Take former drug re-packager Advantage Dose, for example, which was responsible for more than 1,000 of them. The company garnered a 38-item Form 483 following a 2008 audit.

The article quotes stats from The Gold Sheet indicating also that role that generics manufacturers may play in the rocketing of recalls. They sometimes cut development costs in their rush to be first to market. So they may not take the time to learn the best way to make that drug.

The stricter drug regulatory environment, engendered in part by heightened Congressional scrutiny of the FDA, is also a contributor to the spike. The likely outcome: increased FDA regulatory power.

- here's the article


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