Congress Investigates Meningitis Outbreak | Chemical & Engineering News
Volume 90 Issue 44 | p. 17 | Concentrates
Issue Date: October 29, 2012

Congress Investigates Meningitis Outbreak

Department: Government & Policy
News Channels: Biological SCENE
Keywords: FDA, compounding pharmacy, drugs, steroids, fungal meningitis

Leaders of the House of Representatives Energy & Commerce Committee have intensified their investigation of the New England Compounding Center, a Massachusetts-based pharmacy that produced injectable steroids linked to the recent multistate fungal meningitis outbreak. In an Oct. 22 letter to Barry Cadden, former owner and president of NECC, lawmakers asked for all documents related to the outbreak, including inspection reports, internal policies, and a history of the pharmacy’s operations. The request comes after the company failed to comply with the committee’s request for a briefing. Lawmakers are examining whether NECC was operating as a drug manufacturer under the guise of a compounding pharmacy to avoid federal regulations. Compounding pharmacies are regulated at the state level, whereas drug manufacturers are regulated by FDA. The Centers for Disease Control & Prevention and FDA have confirmed the presence of the fungus Exserohilum rostratum in unopened vials of preservative-free methylprednisolone acetate produced and shipped by NECC. CDC estimates that about 14,000 patients may have received injections of the contaminated steroids. As of Oct. 22, CDC reported 294 cases of fungal meningitis, three peripheral joint infections, and 23 deaths associated with the drugs. The company voluntarily recalled all of its products on Oct. 6.

 
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