Reps slam FDA at testy hearing on meningitis outbreak

Members questioned Food and Drug Administration (FDA) Commissioner Margaret Hamburg as they debated the need for stricter federal rules on compounding pharmacies, which reprocess drugs to meet patients’ special needs. 

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The meningitis outbreak has been linked to a drug compounder, the New England Compounding Center (NECC), that distributed specialized medications on a wide scale before closing this fall.

The NECC received several complaints over the last decade over products that state and federal regulators felt might endanger public health. Its steroid injections, administered for back pain, are seen as the cause of the current outbreak. 

On Wednesday, House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) blamed the FDA for failing to conduct a “single follow-up inspection” after noting problems with the company’s sterility practices. 

“Ten years later, we are in the midst of an unthinkable, worst-case scenario: The body count is growing by the day, and hundreds have fallen ill. This is simply inexcusable,” Upton said.

In several testy exchanges, lawmakers pushed Hamburg to explain what steps the FDA took to ensure NECC products were safe. 

Hamburg said that the agency shares authority with state regulators, making some enforcement actions difficult. 

She also urged Congress to clarify and strengthen the FDA’s oversight of drug compounders, which has been the topic of several conflicting court decisions, in response to the current outbreak.

“The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take,” Hamburg said. 

“In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding.” 

The Energy and Commerce subcommittee on Oversight and Investigations conducted the hearing. A Massachusetts regulator and the wife of a man killed in the outbreak also testified.

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