Unless you have been living under a rock for the past month, you have heard about the deadly fungal meningitis outbreak that was traced back to defective drugs distributed by a Massachusetts pharmacy. After more than 30 people have died and hundreds more have been stricken ill, blame is starting to fall on those who may have prevented the deadly outbreak.
Today it was reported that the director of the Massachusetts Board of Registration in Pharmacy, the governing body of the pharmacies in the state, has been fired. It was reported that the director ignored a complaint against the pharmacy responsible for the outbreak, New England Compounding Center (NECC).
Reportedly, back in July, Colorado health officials alerted the board that NECC was operating like a drug manufacturer instead of a compounding pharmacy, as it was licensed to be. The interim commissioner of the Massachusetts health department said the director failed to act on those complaints, which was “incomprehensible.”
Because NECC was licensed as a compounding pharmacy, it was only allowed to make drugs on a patient-specific basis after receiving a valid prescription. The complaint from the Colorado health department said NECC was overstepping its boundaries by distrusting drugs to hospitals without having the prescriptions in advance.
The U.S. Food and Drug Administration did not regulate NECC cause of its status as a compounding pharmacy and not a drug manufacturer; however, both the FDA and Massachusetts health department have admitted that NECC was actually operating more like a drug maker.
Both the FDA and the Massachusetts health department could potentially face liability in personal injury lawsuits brought by people who were treated with the tainted steroid drugs. More than 17,000 vials of the steroid were shipped to clinics throughout the country without prescriptions. The clinics could potentially face liability as well.
Source: MedPage Today, “Meningitis: Head of Pharmacy Board Fired,” Michael Smith, Nov. 8, 2012