More Question Than Answers at First Fungal Meningitis Outbreak Hearing

Posted on November 16, 2012

Members of Congress were left with potentially more questions than answers on the heels of a hearing called to figure out how a fungal meningitis outbreak was able to occur.

The outbreak, which has already claimed the lives of 32 people and infected hundreds more, was the result of contaminated steroid injections distributed across the country by the New England Compounding Center.  One of the co-owners of that facility was brought to speak in front of the House Energy and Commerce oversight subcommitee, but his testimony was virtually non-existent.  His attorney cited the client’s need not to speak because of the ongoing investigation, and the individual consistently called upon the 5th Amendment when asked to speak.

One individual who did speak was the Commissioner of the Food and Drug Administration.  She expressed her sadness at the fact that a regulatory gap was such such an incident was allowed to happen.  That gap results from the nature of the compounder.  Although compounders, which were meant to give specially ordered drugs to doctors who request them for patients with special needs, are supposed to be regulated at the state level, the NECC worked more like a manufacturer, shipping drugs across the country, which would put them more in line with FDA regulation.

Both the FDA and lawmakers hope that this potential regulatory pitfall can be ironed out with future legislation.  Stay tuned as more information continues to come to the fore.  Hopefully incidents like this outbreak can be avoided with future legislative efforts.

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