Besides operating under severely unsanitary conditions, the New England Compounding Center that distributed injectable painkillers contaminated with fungus was doing more than just compounding for individual patients, and should have been subject to FDA inspections.
With 377 people across 19 states to date infected by epidural painkillers contaminated with fungus, and a fatality count of 28, physicians are justified in wondering whether they can ever trust these injections again, and how such an outbreak could have happened in the first place. The answer includes a loophole in pharmaceutical oversight, and efforts are under way to close it.
The FDA, the Centers for Disease Control and Prevention, and the Massachusetts Board of Pharmacy have conducted an investigation of the compounding pharmacy responsible for the meningitis outbreak, the New England Compounding Center (NECC) of Framingham MA. In addition to identifying the fungus that caused the outbreak, Exserohilum rostratum, the investigators have identified severe health and safety deficiencies in NECC’s procedures.
According to a preliminary report of the findings , the general environment inside the facilities was found to be unsanitary, and bacterial as well as fungal contaminants were discovered. The FDA has revealed that the company was aware of the safety violations but there is no evidence that its employees investigated or sought to correct the problems.
“NECC distributed large batches of compounded sterile products directly to facilities apparently for general use,” the report adds, “rather than requiring a prescription for an individual patient.” In other words, apparently NECC had been producing drugs in bulk, rather than acting purely as a compounding pharmacy. Thus it should have come under FDA regulation, which it evidently escaped.
Although the FDA is authorized to regulate all standard drug manufacturers, compounding pharmacies (which combine ingredients to custom-create drugs for individual patients) do not fall under this category but are subject to regulations that vary state by state. The fact that their products are commonly transported between states complicates the picture.
Congressman Edward J. Markey of Massachusetts, whose congressional district includes NECC, is reportedly preparing a federal bill to strengthen regulations for compounding pharmacies. The bill would require compound drugs to be labeled so that healthcare providers could be aware of the exact source of the drugs they are prescribing, as well as whether or not the FDA has tested the drug.