Committee Leaders Request Documents Related to Deadly Meningitis Outbreak
House Energy and Commerce Committee leaders today sent letters to the New England Compounding Center (NECC) and one of its former owners to seek documents related to the recent outbreak of fungal meningitis as well as the history of investigations and operations of the NECC and associated entities. The bipartisan group of members requested all inspection reports, documents related to the analysis of the drug linked to the infections, internal policies or guidance, and communications with state, federal, and third party authorities. The committee also requested Mr. Barry Cadden—former owner, president, and director of pharmacy for the NECC—provide related documents containing communications sent or received using a personal email account. This request comes after counsel to Mr. Cadden informed committee staff that his client does not intend to comply with an October 11, 2012, request for briefings on the outbreak.
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 a traditional compounding pharmacy or a drug manufacturer.
The members wrote to NECC's counsel, "During initial discussions with committee staff on October 12, 2012, FDA officials could not confirm whether the agency conducted any follow-up inspections. However, they informed committee staff that the NECC corresponded with FDA about a month after the warning letter and assured regulators that the firm was in compliance with good compounding practices.
"The joint FDA and state inspection of the NECC’s Framingham facility initiated at the end of 2004 was not the first such inspection. On October 18, 2012, Massachusetts public health officials informed committee staff that a joint inspection of the NECC was also conducted in 2002 and 2003, based in part on an adverse event reported via FDA’s MedWatch system. This event was associated with the methylprednisolone product implicated in the recent outbreak. According to a January 10, 2006, consent agreement between the NECC and the Massachusetts Board of Pharmacy, 'this Agreement is in settlement of complaints relating to an adverse complaint report investigated by the United States Food and Drug Administration for methylprednisolone acetate preservative free 80 mg/ml suspension...'”
The members continued, “The NECC reportedly produced and shipped, at times in bulk, over 17,000 vials of methylprednisolone acetate to seventy-six different facilities in twenty-three states, without individual prescriptions for each order. The committee seeks to determine how long the NECC has been operating in this manner and why, six years after FDA’s warning letter and ten years after an inspection relating to methylprednisolone acetate produced and distributed by the NECC, the company was able to continue to do so.”
In a letter to Mr. Cadden, the committee leaders wrote, “While we are disappointed that neither you nor anyone else from the NECC could make themselves available to brief committee staff, the committee must proceed with the investigation. We expect that you will cooperate in this matter.”
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