The outbreak of fungal meningitis due to contaminated drugs from New England Compounding Center brings to mind a 1997 FDA inspection and report of the Lansing, Michigan anthrax vaccine manufacturer, which at that time was a state of Michigan subsidiary: Michigan Biologic Products Institute. Many of the same types of manufacturing failures were noted then as seen now in Framingham, MA:
- visible particulates (that looked like mold) were seen in vaccine vials from some lots
- the manufacturer failed to test product lots as specified by FDA regulations
- widespread failures of sterility tests were seen when performed by FDA--whereas when they had been performed by the manufacturer the vials had passed
- mold was growing in rooms used for product manufacture
- processes that were used to guarantee sterility, even if performed correctly, were probably not effective
And from just this one manufacturing facility, 338 life-threatening infections and 25 deaths have been identified.
It is uncertain how many people were damaged by poorly manufactured anthrax vaccine. What we do know is that the manufacturing facility for anthrax vaccine, which was owned by the state of Michigan with federally supplied equipment and oversight by US Army inspectors, chose to bulldoze the entire anthrax manufacturing facility shortly after the inspection.
FDA claims it lacks both funding and manpower to perform inspections of drug and vaccine manufacturers at least every two years. In the case of compounding pharmacies, FDA has claimed it lacked authority to perform the inspections:
Deborah Autor, the FDA deputy commissioner for global regulatory operations and policy, says the agency’s hands are tied.
“The FDA’s regulatory authority over compounding pharmacies is limited by law. Because of these limitations, compounded drugs are not FDA-approved for safety and efficacy, and compounding pharmacies are not generally required to tell the agency what products they are making,” she wrote in a USA Today opinion piece. “The FDA’s authority to inspect compounders’ records is also limited. Each compounding pharmacy is licensed by its state’s board of pharmacy, which has primary day-to-day oversight.”Yet FDA issued a warning letter against NECC back in 2006, and NECC was making large batches of drugs back then, more like a manufacturer than a compounding pharmacy.
FDA failed to inspect the anthrax plant for a number of years, until the Army announced it would begin to vaccinate over 2 million service-members with the vaccine. In those days, the Army was said to have oversight authority. Clarity over the issue of who is responsible to oversee the safe operation of American drug manufacturers is needed, asap.
Congress has now become involved, trying to learn the entire history of interactions between NECC and the FDA.