Committee Leaders Expand Investigation into Fungal Meningitis Outbreak, Seek Information from Massachusetts Pharmacy Board Responsible for Overseeing New England Compounding Center
House Energy and Commerce Committee leaders today expanded their investigation into the recent fungal meningitis outbreak linked to a contaminated injectable steroid compounded and distributed by the New England Compounding Center (NECC) in Framingham, Massachusetts. Of the 14,000 patients injected with the drug product, fourteen people have died and at least 170 people have been sickened across the nation.
In September 2004, the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy inspected the NECC. In December 2006, FDA sent the NECC a warning letter detailing significant violations witnessed by the investigators. Included in the list of violations was the NECC’s manipulation of a sterile injected product. In addition to citing the public safety concerns, the FDA also questioned whether the NECC was operating as traditional compounding pharmacy or a drug manufacturer.
The members wrote, “The committee is investigating whether any remedial measures were taken after this inspection and why the NECC was able to continue operating in this manner more than six years after the fact... To assist the committee in better understanding the NECC’s operations, as well any actions taken by the Board of Pharmacy to address potential violations, we ask that you make arrangements with Committee staff to schedule a briefing on these matters to occur no later than October 19, 2012.”
The members requested a copy of all inspection reports and records in the possession of the Board of Pharmacy and all communications related to any facilities owned or operated by NECC or Ameridose.
Earlier this week, the committee leaders requested briefings from the CDC and FDA as well as the NECC.
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