FDA chief to testify on meningitis outbreak at House hearing

Food and Drug Administration (FDA) Commissioner Margaret Hamburg is scheduled to testify before lawmakers on the outbreak of fungal meningitis that has killed 30 nationwide.

The outbreak has been linked to tainted steroid injections distributed by the New England Compounding Center (NECC), a Framingham, Mass.-based drug compounder that has now surrendered its license and recalled its products.

Federal health officials first learned of the outbreak in late September, and Congress has been pushing for details while in recess. 

Part of this effort means grilling the FDA on its oversight of the pharmacy behind the injections. Nine lawmakers from the House Energy and Commerce Committee wrote to the agency on Nov. 17, implying that regulators did not push the NECC to address key code violations.

Some of those members will have a chance to raise the concerns with Hamburg on Nov. 14, when the Energy and Commerce subcommittee on Oversight holds its hearing.

"The NECC has a history of problems, some of which were documented in an FDA warning letter in 2006," lawmakers said, announcing the event. "We want to know what went wrong at this facility, the views and actions of its regulators, and what steps can be taken to ensure such an outbreak never happens again."

James Coffey, who directs the Massachusetts Board of Registration in Pharmacy, and Barry Cadden, who owns the NECC, have also been invited to testify, the committee said.

More than 400 have been diagnosed with cases of meningitis linked to NECC products, and at least two House Democrats have introduced bills to strengthen federal oversight of firms like the NECC.

Drug compounders can remix and distribute medications on a large scale but are not obligated to follow rules that apply to drug makers.

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