The furor over the mass outbreak of fungal meningitis continues. The U.S. Centers for Disease Control and Prevention issued updated information recently on the scope of the outbreak. According to their tallies, at least 480 patients have developed fungal meningits because of the contaminated epidural shots that they received. The death toll has also risen, with 33 individuals having died from meningitis complications. In most cases the deaths were caused by the patient suffering a stroke which was spurred by the fungal infection. We know that at least two of the infected patients are in Illinois. When the outbreak first made national news, officials from the Illinois Department of Public Health explained that three facilies (two in Chicago and one in Westerchester) were known to have distributed the steroids to patients. All told about 350 Illinois patients likely received the tainted shot.
Fury Over Lack of Oversight
In the months since the outbreak there has been growing concern regarding the apparent lack of oversight at the New England Compounding Center (NECC). Several members of Congress have begun asking tough questions of state and federal officials to better understand what went wrong and what should be done to prevent repeat occurrences.
A recent NBC News story on the topic delved into the regulatory confusion and the stark reality that, without changes, a similar problem could develop again. In fact, the U.S. Food and Drug Administration sent a letter to members of Congress admitting that they currently have little information about the state of pharmaceutical compounding facilities across the country. That is because most of the regulation falls to individual states, without comprehensive federal oversight. As such, each state is free to make its own decisions about the strictness of regulations and the punishments for past problems.
For example, officials were on notice for at least a decade of possible problems at the NECC. Past safety violations were documented, but little was done to ensure the problems were fixed and no future problems develped. In fact, at the time of the outbreak, the facility was operating beyond the scope of its state license. According to reports, the facility was not supposed to be mass producing and shipping drugs. But it was, and those operations are what led to the current crisis. Should state regulators have know about the facility’s breaches? Could it have done anything to stop it? Those are questions that many are now asking and that might lead to legisltive changes in the coming months.
Also, members of Congress are not pinning the problem only on state regulators. The U.S. FDA was also made aware of various problem years before. At a hearing on the issue, one Senator listed a string of citations, past contaminations, and sick patients that were tied to problems at the NECC. All of those issues were reported to the FDA. Yet, the only thing that the agency did, after several violations, was send a warning letter. Little to nothing was done to actually hold the wrongdoers accountable and ensure patients were not exposed to long-term risks as a result of chronic safety and sterilization problems at the plant.
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