Regulators Faulted for 'Inertia' Over Meningitis Concerns

• U.S. NEWS
• November 15, 2012, 10:12 p.m. 

• By THOMAS M. BURTON

  WASHINGTON—A congressional report on Thursday released details of how federal and state regulators knew nearly a decade ago of serious safety concerns with the pharmacy tied to hundreds of meningitis cases, but failed to act decisively.
  Bipartisan staff of the Senate Health, Education, Labor and Pensions Committee concluded in a report that "bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health."
  The report was released at a Senate hearing into the causes of the meningitis outbreak in more than 460 patients stemming from a steroid injection made by the New England Compounding Center of Framingham, Mass. It came a day after a House hearing on the same issue.
  Senators in both parties expressed interest at the hearing in clarifying the Food and Drug Administration's role in supervising such drug-mixing pharmacies. But they and staff said there has been plenty of evidence that the FDA should have taken action against NECC regardless of weaknesses in current regulatory law.
  "Both federal and state regulators were well aware that NECC and its owners posed a risk to the public health," the Senate investigators wrote. Both the FDA and the Massachusetts' Board of Pharmacy had documented that NECC "repeatedly failed to demonstrate that the company could safely compound sterile products," the report concluded.
  NECC said it has no comment "at this time" on the report.
  The cases of rare fungal meningitis—including 32 deaths thus far—occurred in patients given the injectable steroid methylprednisolone in recent months. Many of the cases involved serious strokes. At the hearing, Sen. Kay Hagan (D., N.C.) told of an elderly patient from her state whose mouth had to be swabbed free of black fungal matter before she died.
  NECC-produced methylprednisolone "had previously been a suspected cause of at least two cases with bacterial meningitis-like symptoms" in 2002, leading to an FDA inspection, the report found. It is unclear whether these were definitively shown to be meningitis. An internal FDA memo in 2003 told of FDA staff concluding there was "potential for serious public health consequences if NECC's compounding practices, in particular those relating to specific sterile products, are not improved."
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