Sunday, April 28, 2013
Fix 'compounding pharmacy' oversight: Our view
he 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.
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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 outbreaktied to tainted injections made by the New England Compounding Center (NECC).
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.
For more than a century, traditional compounders have provided a vital service, mixing prescriptions for individual patients who need something customized, such as a liquid for someone who can't swallow pills. By the late 1990s, however, some compounders envisioned big profits in making large batches of medicine and selling to clinics and hospitals all over the country — essentially acting like manufacturers.
The lethal problems range far beyond NECC. In recent inspections, the FDA found dozens of safety problems at large-scale compounders across the USA — from black particles in injectable medicines to rust and mold in supposedly sterile rooms. In a survey, Rep. Edward Markey, D-Mass., said he found compounders going "untracked, unregulated and underinspected" by states.
At the now-shuttered New England Compounding Center, the FDA and Massachusetts health officials knew of problems with company products, including the same medication suspected in the recent deaths, as far back as 2006. But aside from a pair of warnings, little action was taken until people started dying.
This month, FDA Commissioner Margaret Hamburg acknowledged to a House committee that her agency "should have more aggressively applied existing authorities." Last week, she told the USA TODAY Editorial Board that oversight of compounders is at "a critical moment" and that "the system is broken." Large-scale compounders, she said, should have to register with the FDA, meet uniform quality standards, label their products, report any adverse drug reactions and be barred from producing certain medications.
All that makes sense, and on Friday a bipartisan group of senators proposed a measure to reach those goals. But any new law faces hurdles, particularly from House Republicans who are so bent on blaming the FDA that they oppose providing the clarity and tools to ensure public safety.
Twice in the past decade, the Senate looked into mounting problems with compounders. After the International Academy of Compounding Pharmacists, the industry's trade group, opposed proposed solutions, Congress did nothing. A spokesman for the group says its leadership has changed, and it wants to work with the Senate. We'll see what happens this time, now that the deadly consequences of inaction are clear
Quoted from THE USAToday