The U.S. Food and Drug Administration released information this weekend on the results of its latest investigations into conduct at the New England Compounding Center (NECC). Of course the NECC is the “drug mixing” company at the center of the fungal meningitis outbreak. Contamination of thousands of vials of a spinal steroid injection led to hundreds of patients developing the serious brain and spinal cord membrane inflammation. At least two dozen have already died as a result of this fiasco. Obviously the FDA will be heavily scrutinizing the facility to determine exactly how this tragedy developed so that similar diasters are prevented in the future.
New FDA Report
According to the Wall Street Journal, the latest FDA report on the facility offers clear evidence that sanitary conditions at the facility were far from ideal. Shockingly, the FDA report explains that about a quarter of the vials examined by investigators contained a greenish-black substance that seemed an obvious indicator of unsafe products. In total fifty individual vials were sent out for testing to check on their safety. The result indicated the scope of the contamination problem at the NECCC: all fifty vials were found to contain fungus. It is no wonder then that the total injury count continues to rise from the outbreak–thousands of vials were likely unsafe.
Considering the wide-spread nature of the contamination, all products made by the facility in recent months–beyond just the spinal steroid vials–have been recalled. In addition, the facility was shut-down and is no longer operating. Because this was not just a single fluke, isolated incident, it was necessary to take significant action to prevent as many patients as possible from unknowingly developing dangerous infections as a result of using the unsafe material made by the NECC.
The FDA report comes on the heels of a report issued by state investigators into the plant, which similarly found obvious signs of problems. The state investigation also identified widespread fungal contamination after testing of various products at the facility. Similarly, they indicated there were sanitary concerns in “clean rooms” at the home. Interestingly, those “clean room” problems were not unknown to the NECC officials themselves. Internal documents from the NECC indicate that there were bacteria problems in the facility as early as January. Yet, so far no evidence has been uncovered suggesting that the bacteria problems was corrected. In other words, the facility knew there were problems but they kept producing and shipping material anyway. If true, this suggests pretty obvious negligence on the part of a company charged with making drugs used by consumers across the country. All forms of contamination in these settings pose obvious risks that the company must deal with.
This is an indicator of the consequences of a business that places profits ahead of common-sense safety steps to keep its consumers safe. This sort of conduct is entirely unaceptable–lives literally hang in the balance. The families who have lost loved ones in this tragedy will never be able to receive full compensation for their injury. However, at the very least, it is important that those affected demand accountability to ensure no similar company act in the same way.
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