Statement from Dr. Madeleine Biondolillo Director of Health Care Safety and Quality Department of Public Health
BOSTON — The Massachusetts Department of Public Health (DPH) is closely collaborating with the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) to jointly investigate an outbreak of Aspergillus (fungal) meningitis in Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia. There are now 105 cases reported, and eight people have died.
Investigation into the exact cause of the outbreak is ongoing locally and nationally. The CDC’s preliminary analyses show that all infected patients have received an injection of preservative-free methylprednisolone acetate, a steroid prepared by the New England Compounding Center (NECC) in Framingham, Massachusetts. DPH took immediate action to protect public health and safety. NECC voluntarily surrendered its license at the request of DPH, and at the direction of public health officials, announced a recall of all products that were distributed from its facility in Framingham. Federal and state health officials continue to recommend that health care providers and consumers not use any product that was prepared by NECC.
DPH conducted an immediate on-site investigation on September 26, and requested NECC's recall of the three principally implicated lots of the steroid. Subsequently, DPH and FDA teams have been on-site at NECC investigating these matters.
Massachusetts regulations stipulate that licensed compounding pharmacies are only permitted to prepare and dispense medications pursuant to a prescription from a registered practitioner for an individual patient. If a compounding pharmacy manufactures without a patient-specific prescription, it would be a violation of the terms of its licensure with the Board of Pharmacy.
Where there are identified concerns with a drug prepared by a compounding pharmacy, the FDA has joint oversight with the state. The FDA and the Massachusetts Board of Pharmacy have planned and conducted joint inquiries for more than a decade, including the 2002-2003 investigation into NECC. These collaborative investigations are essential to maximizing regulatory oversight, and ensuring public safety. All matters concerning NECC drug compounding and distribution will remain under joint investigation by federal authorities and DPH until this outbreak is resolved.
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