Meningitis Outbreak Leads to FDA Inspection and Calls for Oversight
Following a widespread meningitis outbreak that has affected hundreds of lives and killed dozens, members of the government are calling for new oversights that could help prevent such an incident in the future.
The New England Compounding Center was responsible for distributing the contaminated steroids thought to be responsible for the outbreak, and the Food and Drug Administration recently conducted an inspection of their facility. Sampling by inspectors turned up white, black, and green foreign matter and filamentous material in 100 vials. Although documents from the company itself suggested a bacterial contamination of a sterile sample, there appears to be no evidence that the company attempted to go further to correct the issue. In addition, floor mats were soiled and a sterilizing autoclave was determined to be tarnished.
The FDA conducted the investigation despite the fact that states typically regulate compounding pharmacies. To prevent such a disaster in the future, a Massachusetts Congressman has released a report saying that the FDA should have future oversight of such large compounders. The commissioner of the FDA expressed hope that the organization would be ready to take up regulation of the industry if that’s what’s decided upon.
As news continues to leak out regarding this meningitis outbreak, it remains vital that anyone who thinks they may have received a contaminated steroid get in touch with a doctor. An estimated 14,000 people have potentially come into contact with a contaminant, and it’s our hope that all persons can get the treatment necessary to preserve their safety.