Tuesday, April 30, 2013

Will Senate fix compounding pharmacy oversight this time?

The first time most people heard of a “compounding pharmacy” was last fall, when people started dying after getting routine shots produced by one such operation in the Boston area. By early this month, the death toll stood at 53, or 50 more than the marathon bombings.

Among the dead was Douglas Wingate, 47, a Virginia account executive whose only complaint was a pinched nerve in his shoulder. He got a steroid shot and became a victim of a meningitis outbreak tied to tainted injections made by the New England Compounding Center.

More than 700 people in 20 states have been sickened, and many are still suffering.

In the aftermath of this public health disaster, Republicans and Democrats in Congress are debating two questions: Has the Food and Drug Administration failed to use its existing authority to oversee compounders such as NECC? Or does the FDA need broader powers?

The answers are yes, and yes. The FDA repeatedly dropped the ball. And the agency’s authority does need to be clarified and expanded.

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