In the latest chapter of the saga surrounding the nationwide fungal meningitis outbreak this fall, the director of the New England Compounding Center, James D. Coffey, was fired. The NECC board's attorney, Susan Manning, has been placed on administrative leave as well.
The New England Compounding Center is the Framingham, Massachusetts-based compounding pharmacy at the center of the fungal meningitis outbreak that, as of Wednesday, has infected 424 people and killed 31. The director was fired because he had ignored a complaint lodged against the company in July.
Dr. Lauren Smith, the interim commissioner of the Massachusetts Department of Public Health, said that they had received a complaint from the Colorado Board of Pharmacy, which said that the pharmacy was sending medication to health facilities that were not filling patient-specific prescriptions. The Colorado Board of Pharmacy also contacted the Food and Drug Administration, which confirmed that NECC was not a licensed drug manufacturer.
Dr. Smith said in a statement that Coffey had forwarded the complaint to Manning and members of the board, but had not investigated the complaint. By the time that they had received the complaint, two of the three tainted shipments had already been shipped out.
Dr. Smith said that it was the responsibility of the director of the board to order investigations.
She also said that, when the New England Compounding Center had begun to come under investigation by the Massachusetts Department of Public Health, Coffey did not disclose this complaint lodged against the company.
"I also expect the staff charged with oversight to perform their duties to the highest standards," Dr. Smith said. "That failed to happen here."
This ordeal is not the first brush that the New England Compounding Center has had with the law in Colorado. Last year, Colorado inspectors discovered that NECC had been distributing, unregistered or unlicensed, drugs in their state. That action prompted a cease-and-desist letter from the state last April.
Years before the outbreak, NECC had come under fire from the Massachusetts Board of Pharmacy, but had escaped punishment. The case raises questions about regulation of the compounding drug industry.
Published by Medicaldaily.com