HELP Committee staff report blames lack of oversight
Reports from both chambers timed to hearings on fungal meningitis outbreak
An investigation by Senate Health, Education, Labor, & Pensions (HELP) Committee staff shows that the fungal meningitis outbreak was a “tragic failure of oversight,” according to a report, The New England Compounding Center and the Meningitis Outbreak of 2012: A Failure to Address Risk to the Public Health.
Released November 15, the date of the HELP Committee hearing on the tragedy, the 14-page report concluded that “bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health,” given that many “authorities and mechanisms for both federal and state regulators to address this issue” existed.
The report describes the history of the New England Compounding Center (NECC) facility linked to the outbreak, as well as its related companies, and their interactions with federal and state regulators.
The HELP Committee hearing, Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak, included testimony from two pharmacy groups; its House Energy & Commerce Subcommittee on Oversight and Investigations counterpart the day before did not. On November 12, the House subcommittee released its own 25-page background memo, devoting 19 pages to a history of federal and state investigations of NECC.
Also on November 12, 11 national pharmacy organizations, including APhA, released a statement on Pharmacists’ Commitment to Patient Safety and Compounding Quality.
Federal and state regulators knew that NECC and its owners were a danger to the public health, according to the HELP Committee report. Federal and state regulators had documented that the company “routinely flouted requirements” to compound products only for a patient-specific prescription, “compounded unapproved and commercially available products,” “potentially destroyed documents and samples relevant to adverse events,” and repeatedly could not demonstrate that it could safely compound sterile products.