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

U.S. FDA/Flickr

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.

The FDA normally doesn't get involved with such practices because it isn't tasked with regulating the legitimate practice of pharmacy. Like the practice of medicine, pharmacy is largely left to professional and state oversight. But once pharmacies begin manufacturing and shipping medicines on a mass scale, they become "drug manufacturers" and fall squarely under the FDA's extensive authority.

There are unambiguous rules governing when a compounding pharmacy crosses the line and becomes subject to FDA supervision. The practice of compounding, for example, does not allow the manufacture of copies (or near copies) of FDA-approved drugs that are commercially available. By all accounts, the New England Compounding Center was hardly a pharmacy as generally understood; it was manufacturing unapproved duplicates of FDA-approved drugs and distributing them for a large-scale market without first receiving valid prescriptions for the individual drugs.

This all put the NECC firmly in violation of FDA rules—if the agency had chosen to enforce existing provisions. But in recent years the FDA has seldom drawn clear lines between practices that are legal and beyond its purview and ones over which it clearly has authority. The regulatory hesitation has meant that some of the shadiest compounding outfits haven't been reined in. And it magnified risks by emboldening more pharmacies to go well beyond traditional compounding and engage in large-scale drug making—because it seemed a fairly safe bet that the FDA wouldn't come knocking.

Meanwhile, the agency has been focused on enforcement activity that could instigate legal showdowns and set judicial precedents that would expand FDA power over the full scope of the practice of pharmacy. Part of this strategy is philosophical: Many at the agency have long believed that all of the professional practice of pharmacy belongs under the FDA's oversight. Then there is regulatory languor: The FDA reasons that if it can assert jurisdiction over the entire profession, then it can more easily pick and choose where to focus its energies, instead of having to establish in advance which firms are crossing the line.

Take, for example, the FDA's recent (and unsuccessful) enforcement action against the compounding firm Franck's Pharmacy, a maker of customized veterinary drugs. Rather than allege that Franck's had crossed the line from traditional pharmacy compounding to drug manufacturing, the FDA took the expansive position that it had the authority to regulate the practice of pharmacy in general and traditional pharmacy compounding in particular. The federal judge overseeing the Franck's case easily rejected FDA's power grab (although the judge didn't dispute, and specifically noted, that the FDA has the authority to regulate drug manufacturing carried out under the guise of traditional compounding).

Ironically, the FDA is now using legal defeats like the one in the Franck's case as the excuse for why it couldn't be tougher on the steroid-maker NECC. This week, the FDA will ask Congress for new authorities to expand its oversight over the practice of pharmacy.

Instead, Congress should instruct the agency to issue regulations that assert the authorities that the FDA already has—drawing a bright line between the traditional practice of pharmacy (regulated by states) and the place where a compounder has crossed the line into drug manufacturing, making itself subject to federal regulation.

The FDA has failed for decades to clearly establish enforcement policies related to pharmacy compounders because the agency doesn't want to concede that it was never supposed to have jurisdiction over the legitimate, local practices of pharmacy and medicine. In the process, the agency has undermined its own mission.

Dr. Gottlieb, a resident fellow at the American Enterprise Institute, was deputy commissioner of the FDA from 2005-07. Mr. Bradshaw was the FDA's chief counsel from 2005-07. He was retained by Franck's Pharmacy as an expert witness in the FDA case against the company.

 

 

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About the Author

 

Scott
Gottlieb
  • Scott Gottlieb, M.D., a practicing physician, has served in various capacities at the Food and Drug Administration, including senior adviser for medical technology; director of medical policy development; and, most recently, deputy commissioner for medical and scientific affairs. Dr. Gottlieb has also served as a senior policy adviser at the Centers for Medicare & Medicaid Services. 

    Click here to read Scott’s Medical Innovation blog.


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