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How Can the FDA Reign-in Compounding Pharmacies?

--by Nina Lincoff

When taking medicine—something as fundamental as a pill or a vaccine or an injection—patients put their lives in the hands of pharmacists and manufacturers. To think that the medication, which should have been approved and tested and verified as safe, is potentially harmful is terrifying. It’s enough to have to worry about a diagnosis, but to question the safety of a cure?

As of now, 34 deaths and 490 injuries have been directly linked to vials of methylprednisolone acetate contaminated with fungal meningitis produced by the New England Compounding Center (NECC), according to the Centers for Disease Control and Prevention (CDC). For the nearly 14,000 patients who were put at risk because of the contaminated steroid, typically used as a spinal injection to ease back pain, the cure may be as worrisome as their initial diagnosis.

This disease outbreak focuses attention on an unfortunate gray area in the world of pharmaceuticals—the difference between a compounding pharmacy and an FDA-regulated pharmaceutical manufacturer.

Oversight of the verification, approval, and production of drugs falls to the Food and Drug Administration (FDA) in the United States. Since 1938, the FDA has been the authority on drug manufacturing by pharmaceutical companies. But the Framingham, Massachusetts-based NECC is not a pharmaceutical company—it falls into the hazy realm of ‘compounding pharmacies.’

So what exactly are compounding pharmacies, and if they manufacture drugs that are distributed on a national level, why aren’t they under the same FDA scrutiny as pharmaceutical manufacturers?

In the late 1930s, production scale simply was not as large as it is today, so accredited neighborhood pharmacists could mix, or ‘compound,’ pharmaceuticals that had been developed, tested, and approved by the FDA for distribution. These compounding pharmacies fell outside of the FDA’s regulation and into the realm of state and local governments because they met a need for small-scale pharmaceutical production and were only meant to serve a few individual patients.

But then came industry.

Industrial-scale producers took advantage of this loophole and began mass-producing drugs, citing a need for compounding services. These companies are not registered with the FDA as drug manufacturers and do not need to garner FDA approval before distribution, which seems like an obvious red flag. The FDA thinks so too. For more than two decades, the agency has tried to tighten regulations on compounding pharmacies, but have come up against opposition from, that’s right, the compounding pharmacies themselves.

A contemporary compounding pharmacy like the NECC takes drugs that have been developed, tested, and approved by FDA-regulated pharmaceutical companies and changes the recipe ever so slightly. Most drugs contain active and inactive ingredients, so the wiggle room in compounding is often found in those ‘inactive ingredients.’

The FDA-approved methylprednisolone acetate compounded by the NECC is manufactured by pharmaceutical giant Pfizer, but the NECC altered the recipe slightly and eliminated the preservative element. As a result, it was only when the FDA went in to the NECC facility after the fungal outbreak that they discovered vials of the steroid with visual contamination.

That means foreign matter floating in vials of drugs sent out for use by ill patients. 

How do these seemingly inferior drugs reach hospitals? It’s all about cost. Compounding pharmacies can manufacture drugs without having to undergo intense oversight, so there are no research and development costs. Drugs can then be sold at a cheaper price, and in a tough economy, a cheaper option is typically welcomed.

Doctors may not know where the drugs they are prescribing come from because what they’re concerned with is patient outcomes. Drugs are supposed to undergo rigorous testing before distribution. And most of the time, they do.

After this outbreak of deadly fungal meningitis, the spotlight is on compounding pharmacies and on the FDA and lawmakers to tighten regulations. On November 1, the FDA and CDC reported that two other NECC products, preservative-free betamethasone repository injection and cardioplegia solution, also contained contaminants.

The Energy and Commerce Committee (ECC), a group of U.S. senators and representatives, held a hearing last week to determine if the fungal meningitis outbreak could have been prevented. As of today, the FDA has until November 30 to provide the ECC with records relating to NECC oversight. We can only hope that legislators will recognize the need to bring all compounding pharmacies into the regulatory fold in order to prevent more harm to patients nation wide.

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Tags: Drugs , Epidemics , Public Health & Policy

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