Protecting patients in wake of meningitis outbreak, while still preserving access to treatment

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While federal and state officials are still investigating this public health disaster, some initial facts appear to be well established, based on published reports.
 
First, the cases purportedly stem from contaminated drugs made by the New England Compounding Center (NECC), which has since suspended operations and recalled its products. This company was churning out thousands and thousands of drugs and shipping them across many state lines, in some instances allegedly without first obtaining valid prescriptions. These practices violate state pharmacy licensing requirements on NECC, which billed itself as a pharmacy. In fact, NECC was acting as a pharmaceutical manufacturer without undergoing the necessary Food and Drug Administration (FDA) registration, inspection and approval to operate as one.
 
Second, red flags about NECC’s activity were raised by FDA and the Massachusetts state board of pharmacy. But neither entity took any meaningful action to stop or suspend NECC’s inappropriate, large-scale pharmaceutical manufacturing under the guise of a pharmacy. After the fact, Massachusetts recently disciplined two state pharmacy board employees, firing one, who failed to act on one of the most glaring NECC warning signs brought to the board staff’s attention by Colorado health officials.
 
There’s plenty here of concern and much more to question about the NECC situation. Congress is rightly conducting hearings that will hopefully lead to some answers to inform any future action by regulators and legislators.

But we also need to preserve patients’ access to the personalized medications that traditional compounding pharmacies produce under doctor’s orders.
 
Traditional pharmacy compounding is the preparation of individual prescriptions based on specific patient need and at the request of a prescriber. That’s in stark contrast to what NECC has allegedly done. In my community and across the country, traditional compounding plays an essential role today -- as it has for decades.
 
Compounding is particularly critical when mass-produced drugs aren’t an option for unique patient needs. Here are some common examples. Pediatricians may want medication flavored or converted into liquid form so that a child can more easily consume it. Some patients, especially those fighting cancer, simply can’t swallow pills. They may need their medications in a liquid, cream or gel format that is not otherwise commercially available. Allergies present an even more common challenge. If manufactured drugs could trigger an allergic reaction, then a pharmacist-compounded medication often becomes the only option.
 
Drug shortages present another challenge that traditional compounding can alleviate. According to the FDA, drug shortages have nearly tripled in recent years. And that’s not accounting for vaccines and some other products. Traditional compounding pharmacies help bridge the gap. Perhaps most notably, during the 2009 nationwide H1N1 (swine flu) outbreak a critical drug, Tamiflu, ran short. Backed by federal health officials and Roche, Tamiflu’s manufacturer, compounding pharmacists made countless doses of the medication that were vital to treating children.
 
In the coming weeks, Congress will continue the important task of identifying necessary steps that will prevent another tragic outbreak. Throughout this process, I urge my colleagues to be mindful of the important role compounded pharmaceutical drugs play in our healthcare system and the health benefits they provide to patients across the country.


Blackburn is a member of the House Energy and Commerce Committee.

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