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Safety

Lawmakers Find FDA Lax On Compounders

by Britt E. Erickson
April 22, 2013 | APPEARED IN VOLUME 91, ISSUE 16

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Credit: CDC Public Health Image Library
Exserohilum rostratum, which can be up to 200 µm long, has been identified as the primary fungus responsible for the 2012 meningitis outbreak.
09116-govcon-exserohilumcxd.jpg
Credit: CDC Public Health Image Library
Exserohilum rostratum, which can be up to 200 µm long, has been identified as the primary fungus responsible for the 2012 meningitis outbreak.

FDA could have acted sooner and possibly averted the deadly 2012 fungal meningitis outbreak attributed to contaminated drugs produced and distributed by the New England Compounding Center and its sister company Ameridose last fall, according to an investigation by the House of Representatives Committee on Energy & Commerce. Thus far, the outbreak has led to 53 deaths and sickened more than 700 people. Lawmakers are accusing FDA of failing to take action despite receiving safety complaints about the companies’ drugs beginning in 2002. FDA has ramped up its investigation of compounding pharmacies and issued violation notices to 28 of them since the outbreak occurred. The agency claims that it needs greater legal clarity regarding its authority to regulate such pharmacies, which are typically regulated at the state level.

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