Meningitis Update - Congress and FDA Oversight

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The CDC reported November 19, 2012 that the updated number of people infected with fungal meningitis has climbed to 490, and the number of related fatalities is now at 34.1

Owner of Implicated Pharmacy Takes the 5th

Congressional hearings took place on November 14 and 15 to determine what went wrong at the New England Compound Center now at the center of the growing fungal meningitis outbreak.

For background into the outbreak see: Symptom Watch Should be Ending Soon: CDC Updates Fungal Meningitis Outbreak

On Wednesday, November 15th, a congressional committee questioned Barry Cadden, co-founder and owner of the New England Compound Center at the center of the outbreak. Mr. Cadden repeatedly declined to answer questions and he chose to use his 5th Amendment right not to incriminate himself.

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A Mostly Unregulated Pharmacy Business

Traditionally compounding centers like this one have avoided strong regulations by the FDA since they are not technically manufacturing pharmaceuticals. They serve physicians and patients by customizing and repackaging medications to fill tailor-made orders. Over the years, some lawmakers have argued that these centers should be more tightly regulated by the FDA.

Currently, state pharmacy boards are charged with oversight of compounding agencies, although some lawmakers have argued they are not properly equipped to oversee these growing businesses. An investigation into the New England Compound Center last month uncovered evidence of unsanitary conditions which may have been avoided with stricter government agency oversight.2

Protect the Patients

As the investigation continues, let's hope that lawmakers put the safety of the patients over the interests of the compounding agencies. Stricter management and oversight of these compounding agencies could have avoided this tragedy.


  1. "Multistate Fungal Meningitis Outbreak Investigation," Centers for Disease Control and Prevention, Updated Nov. 19, 2012, Accessed Nov. 26, 2012, Accessed via CDC Website.
  2. Viebeck E, "GOP lawmakers push FDA on documents for meningitis probe,", published Nov. 19, 2012, Accessed Nov. 26, 2012, Accessed via Healthwatch Blog.
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