A Compounding Fracture at the FDA The agency has been slow to exercise control over pharmacies that mass produce drugs.

By SCOTT GOTTLIEB AND SHELDON BRADSHAW

The recent deadly outbreak of meningitis caused by spinal injections of a contaminated steroid has cast a spotlight on the practice of pharmacy compounding—when pharmacists mix or adapt medicines to make a specific prescribed treatment. The House and Senate are holding oversight hearings this week on the tragedy that has sickened at least 438 people and is believed to have killed more than 30.

Congress wants to know why the Food and Drug Administration didn't do more to prevent the production and sale of tainted steroids by the New England Compounding Center. The FDA will likely say that it doesn't have enough authority to regulate the pharmacies that compound drugs.

But the FDA does have enough authority. And it did in 2006, when the agency sent a warning letter to the New England Compounding Center, in effect telling the NECC to stop manufacturing certain drugs or face legal action. In 2006, the warning came because the compounding pharmacy was, among other things, violating regulatory rules by producing drugs that were already commercially available from FDA-approved manufacturers. Six years later, NECC was not only still operating but also, it has become clear, selling tainted drugs. Where was the FDA? What was the problem?

The trouble didn't come from traditional compounding, which is a legitimate part of the practice of pharmacy. Compounding pharmacies mix or alter drug ingredients to adapt a medicine based on a doctor's prescription—for example by changing a pill into a formula, tailoring chemotherapy, or adding cherry flavoring to a child's medicine. The practice lets physicians customize drugs to individual patients. Traditional pharmacy compounding typically is performed on a small scale and is always performed in response to a valid prescription.

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