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FDA Flummoxed by Fungal Meningitis Problem

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FDA Commissioner Dr. Margaret Hamburg told a Congressional committee that the agency does not have a good handle on compounding pharmacies that are acting like manufacturers. That was the situation with the New England Compounding Center, which was responsible for making the tainted injections that caused so much harm to so many.

It comes as a great surprise to Americans to learn that neither the FDA nor the states are really in charge. That means that dozens, hundreds or even thousands (no one knows for sure) of compounding pharmacies that are acting like mini drug companies are going unsupervised. Most states really don't have the resources to investigate and inspect these facilities. The FDA has no idea how many there, where they are located or even how to find out.

At the time of this writing nearly 500 people have become seriously ill because of contaminated steroid injections and over 30 have died. What worries us more than anything is Dr. Hamburg's admission that this kind of tragedy could happen again.

And here's something that no one wants to talk about. Hospital pharmacies also do a significant amount of compounding. Think about intravenous solutions, special formulations and tailored doses of drugs. Is there a "clean" room where sterile products are compounded? Is it state of the art or old and decrepit? State boards of pharmacy vary in their expertise and capacity to monitor hospital pharmacies on a regular basis.

So, what's a patient to do? Just as we have warned about generic drugs made in unsupervised chemical plants in China, India, Malaysia, Brazil, Jordan, Mexico and goodness knows where else, we now are sending up a cautionary flag about injectable drugs made by compounding pharmacies. Make sure your doctor tells you exactly where the medicine came from. It may be difficult to track quality on compounding pharmacies, but until the FDA actually figures out how to monitor this confusing situation the consumer and the physician will need to be more vigilant than ever.

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Perhaps, if the FDA spent more of its resources supervising this sort of activity and less harassing Amish dairy farmers, we would all be a bit safer.

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