FDA Reports on Pharmacy Linked to Meningitis Sought
A congressional committee is raising questions about the monitoring of the compounding pharmacy tied to the nation’s deadly fungal meningitis outbreak after potential violations were discovered there by federal regulators six years ago.
Bloomberg reports that the House Energy and Commerce Committee sent a letter last week to the Commissioner of the Food and Drug Administration (FDA) regarding the agency’s oversight of the New England Compounding Center (NECC). The committee’s letter cites a 2006 FDA warning to the pharmacy regarding “potential microbial contamination” and it seeks agency inspection reports dating back to 2004 regarding possible violations at NECC.
The letter from the committee also asked the FDA to confirm whether the agency had launched any subsequent inspections to verify NECC’s claims that it was in compliance after the 2006 warning, reports Bloomberg. The FDA has until Oct. 31 to meet the committee’s request for information.
Compounding pharmacies typically prepare unique prescriptions on an individual basis and are not strictly regulated by the FDA, according to Bloomberg. However, the FDA’s 2006 warning letter also questioned whether NECC was operating more like a drug manufacturer.
So far fungus-tainted steroid shots of methylprednisolone acetate, manufactured at NECC, have infected 285 people in 16 states and resulted in 23 deaths, according to the Centers for Disease Control and Prevention (CDC).
NECC faces investigations by federal and state health officials and the Department of Justice into the fungal meningitis outbreak linked to some of its medications. A number of lawsuits, including several class actions, have also been filed against the pharmacy.
The Massachusetts company has recalled all its products, ceased operations, and is cooperating with investigators.
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