The scandal over the meningitis outbreak attributed to the New England Compounding Center took a new turn yesterday when Massachusetts state health officials fired state pharmacy board Jim Coffey and placed board attorney Susan Manning on leave for allegedly ignoring a complaint last July that bulk shipments of drugs were distributed to hospitals in Colorado.
"It is incomprehensible that Mr. Coffey and Ms. Manning did not act on the Colorado complaint given NECC’s past, and their responsibility to investigate complaints. Following the outbreak, staff also failed to disclose the existence of Colorado’s complaint to leadership at the Department of Public Health," DPH interim commish Lauren Smith says in a statement.
The move came as the US Centers for Disease Control and Prevention increased the number of cases in the nationwide outbreak to 424, which includes 414 cases of fungal meningitis and 10 joint infections. At least 31 people have died. And Congress will hold a hearing next Wednesday, where FDA commish Margaret Hamburg will testify (see here). Coffey was also expected to testify, by the way.
The NECC has been cited for running not-so-clean rooms where materials for drugs were stored and later produced. A recent FDA inspection found numerous places where mold and bacteria were growing, ‘greenish-black foreign matter’ on sterilization equipment and regularly turned off air conditioning each night, despite the need to control temperatures (read this).
However, NECC has also drawn belated scrutiny for taking compounding pharmacy to a different level. Rather than merely make needed medications on a patient-by-patient basis, NECC essentially transformed itself into a drugmaker by producing large quantities of medications and then shipping these to out-of-state destinations.
For this reason, both the FDA and Massachusetts authorities have been criticized for not acting sooner to thwart its activities, despite complaints and an FDA warning letter issued in 2006. The pharmacy board employees were fired because the NECC violated the terms of its license by engaging in bulk distribution of product.
The information provided by Colorado authorities showed that NECC had distributed manufactured drugs to many hospitals in that state between 2010 and 2012 without patient-specific prescriptions, which violates NECC licenses in both states, Smith continued. The complaint filed by the Colorado Board of Pharmacy was filed on July 26 (read the correspondence and report here and here).