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May 30, 2017

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US widens scrutiny of meningitis outbreak

WASHINGTON -- The U.S. House of Representatives on Friday widened its investigation into the deadly meningitis outbreak to include the role health regulators played in monitoring the pharmacy that produced steroid treatments suspected of causing the crisis.

The House Energy and Commerce Committee called on the Massachusetts pharmacy board to tell congressional staff what it knew about the New England Compounding Center (NECC) before the recall of more than 17,000 vials of sterile injectable steroid treatments for back and joint pain from health facilities in 23 states. Massachusetts board officials were not immediately available for comment.

The panel, which oversees health issues including drug safety, said the U.S. Food and Drug Administration was aware of production problems at the NECC in 2006, including potential public health risks involving a different sterile injectable drug.

The rare fungal form of meningitis has killed 14 people in 12 states, with the first case reported in Texas on Friday. The number of cases nationwide reached 184, an increase of 15 from Thursday, according to the Centers for Disease Control and Prevention.

The outbreak is a major national health scandal, with multiple investigations under way and a leading Democratic lawmaker, Senator Richard Blumenthal of Connecticut, calling for a criminal investigation of the company.

The House committee asked the Massachusetts regulator to agree to a briefing no later than Oct. 19 and requested all inspection reports, records and communications related to NECC and its sister pharmacy, Ameridose LLC.

"The committee is investigating whether any remedial measures were taken after this inspection and why the NECC was able to continue operating in this manner more than six years after the fact," Republican Fred Upton, the committee chairman, said in a letter co-authored by six other panel members.

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