November 8, 2012
BOSTON (AP) -- The director of the Massachusetts pharmacy board has been fired for ignoring a complaint that a company linked to a deadly meningitis outbreak was violating its license by shipping drugs in bulk.
The Colorado pharmacy board complained about the New England Compounding Center in July, before the third of three batches of tainted steroids tied to the outbreak was shipped in August. A spokesman said state investigators are still looking into any sickness or deaths related to that third batch.
After receiving the report, director James D. Coffey told Colorado officials that the Board of Registration in Pharmacy would "respond as soon as possible following a thorough analysis of (the report)."
Coffey forwarded the complaint to the board's attorney, Susan Manning, who also failed to act, state officials said.
The two didn't notify leadership at the state Department of Public Health about the Colorado complaint, which investigators discovered last weekend while sifting through Coffey's emails, said Massachusetts Office of Health and Human Services spokesman Alec Loftus.
Coffey was fired Tuesday; Manning has been placed on administrative leave. Their replacements have not been publicly announced.
Massachusetts Interim Public Health Commissioner Dr. Lauren Smith said it was ultimately Coffey's duty as board director to initiate an investigation.
She called it "incomprehensible" that Coffey and Manning did nothing, especially given past problems at the NECC.
"I ... expect the staff charged with oversight to perform their duties to the highest standards," Smith said. "That failed to happen here."
Efforts to contact Coffey and Manning for comment were not successful.
Compounding pharmacies custom-mix drugs in doses or forms that generally aren't commercially available.
A contaminated steroid produced at the New England Compounding Center and used mainly to treat back pain has been linked to a fungal meningitis outbreak that has spread to 19 states, sickening more than 400 people, including 31 who died.
In September, the company recalled three batches of steroids, totaling 17,676 single-dose vials of medicine, made since May.
The NECC, located in Framingham, outside Boston, was authorized by its state license only to fill specific prescriptions for individual patients.
Pharmacies that produce drugs in bulk are subject to federal oversight, and state officials have accused the NECC of masking its true nature as a drug manufacturer to escape more stringent regulation.
Colorado officials first dealt with the company in April 2011, when the board there issued a cease-and-desist order for the NECC, ordering it to stop "the unlawful distribution of prescription drugs in the state of Colorado." The order came after an inspector discovered NECC drugs stored for general use at a hospital in Lone Tree, Colo., near Denver.
Then in July, another inspector found bulk quantities of other NECC-made drugs at a hospital in St. Delta, Colo.
After confirming with the U.S. Food and Drug Administration that the NECC was not registered as a drug manufacturer, the Colorado officials emailed Coffey.
The NECC has been closed since early last month, and Massachusetts officials have taken steps to permanently revoke its license. Federal and state investigators have found evidence of unsanitary conditions and practices at the company, and federal investigators are conducting a criminal investigation.
A company spokesman has said it was always NECC's intent to obey the law in every state in which it was licensed.
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