Meningitis Outbreak Prompts Calls for FDA to Regulate Compounders


Meningitis Outbreak Prompts Calls for Legislation

Sen. Pat Roberts (R-Kan.) took particular interest in Thursday's hearing, having supported an amendment to the 1997 FDA Modernization Act that would have allowed the FDA a closer look at regulated compounded pharmacies. That language was stripped from a final bill.

He offered several ideas to help prevent another NECC-like event from happening again, including:

Ensuring states are properly overseeing compounding pharmacies

Making sure schools are training compounders correctly

Implementing criteria to determine whether companies should be regulated by states or by the FDA

Requiring adverse event reporting for compounding pharmacies

Labeling compounded products as such

Dr. Marion Kainer, director of healthcare associated infections at the Tennessee Department of Health, told senators Thursday that some providers in the current outbreak believed they were buying steroids from a manufacturer and not a compounder because products weren't labeled as being compounded.

The bipartisan push for some sort of legislation in the Senate was not as unanimous in the House during Wednesday's hearing.

While House Democrats were pushing for legislation even as soon as next month, their Republican counterparts said they believe the FDA had all the authority it needed to prevent the NECC and the meningitis outbreak. However, some were open to the idea of legislation if the FDA can prove where its authority is lacking.

Lawmakers from both parties and in both chambers criticized the FDA and the Massachusetts Department of Public Health over the 2 days of hearings for not doing more to stop the NECC, which has been known since at least 2002 to be mass-producing drugs in unsanitary conditions.

The FDA said that in the 1997 FDA Modernization Act, Congress exempted compounders from the agency's purview, and efforts to regulate them have been blocked by various federal circuit courts.

Senators requested documents from the FDA, NECC, and Massachusetts health officials in their investigation, and received 10,000 pages summarizing the near decade-long relationship between NECC and regulators.

"There were a number of authorities and mechanisms for both federal and state regulators to address this issue, but bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health," the report concluded.

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