Readers of the Monitor may be aware that we’ve been following events concerning New England Compounding Center, the pharmacy at the center of allegations of a tainted-drug meningitis outbreak. When the story caught our eye, one of the questions we asked was whether oversight bodies would be put under the microscope. It appears that question has been answered, at least in part: on Wednesday last week, the head of the Massachusetts Board of Pharmacy was terminated after reports surfaced that he did not act on a July 26 complaint concerning NECC.
In late July, authorities from the Colorado Pharmacy Board forwarded a complaint about NECC to the Massachusetts Pharmacy Board. The Colorado regulators reported that NECC had been distributing drugs to hospitals in Colorado and Massachusetts in violation of its license. The head of the Massachusetts Pharmacy Board, however, did not take any action at that time, or at any time before reports of a meningitis outbreak began to surface.
The dismissal is a notable event. It is not often that regulators are held accountable for perceived lapses in oversight, particularly during the immediate aftermath. Furthermore, it’s clear that the dust has not yet settled: hearings are currently scheduled before the House and the Senate, where the Commissioner of FDA will testify, the former head of the Massachusetts Pharmacy Board has been invited to appear, and the co-owner of NECC has been subpoenaed to testify.
Meanwhile, regulators back in Massachusetts have turned their sights on other compounding pharmacies by conducting snap inspections across the state. Those inspections led to the voluntary surrender of its compounding license by Infusion Resources, another compounding pharmacy.
As we previously noted, compounding pharmacies are not subject to the same level of FDA oversight as regular drug manufacturers. That, however, could change, particularly in light of the upcoming hearings before Congress. We will continue to follow this issue as it unfolds and keep you posted here.