The drug company embroiled in the US meningitis outbreak was told in 2003 that its compounding activities did not constitute a manufacturing operation that would meet federal safety standards, according to a congressional report.
At the time, state officials decided to leave oversight of the New England Compounding Center (NECC) to a state pharmacy board, despite evidence of health problems linked to two drugs in 2002, reports Reuters.
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One of these drugs, methylprednisolone acetate, is the same drug linked to the current outbreak of fungal meningitis, which has claimed 32 lives.
The House Energy and Commerce Committee, which published the report, will hold a hearing on Wednesday to discuss whether the outbreak could have been prevented.
The hearing will examine facts surrounding the spread of the disease and other infections linked to contaminated injectable products made and distributed by the NECC.
It will also determine whether the US Food and Drug Administration and Massachusettes state officials should be given stronger authority to regulate compounding operations.
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By GlobalDataLast month it was reported that the NECC sacrificed sterility procedures in order to ship drugs around the country more quickly.
Records show that when the NECC sterilised equipment, they failed to do so for the minimum recommended amount of time, and mats used to trap dust and dirt were “visibly soiled with assorted debris,” according to a report released on Tuesday by the state’s Board of Registration in Pharmacy.
A leaking boiler next to a clean room also “created an environment susceptible to contaminant growth,” said Massachusetts Department of Public Health representative Dr Madeleine Biondolillo, during a news conference.
