New Documents Detail The Ineffective Regulation Efforts Of The FDA In The Meningitis Outbreak

November 22, 2012

Lawrence LeBlond for redOrbit.com – Your Universe Online

New details have emerged over the US Food and Drug Administration’s (FDA) ineffective efforts to regulate a Massachusetts drug maker that has been at the center of the national meningitis health crisis this year.

The deadly meningitis outbreak, which has so far sickened close to 500 people, and has killed 34, is directly linked to steroidal injections produced by Massachusetts-based New England Compounding Center. In documents released Tuesday, the FDA said it would use its full authority to force NECC into compliance, only to back down because of lack of jurisdiction.
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Ongoing inspections at NECC by the FDA and Massachusetts Board of Pharmacy have found several possible sources for the contamination, including leaking water, uncontrolled temperature and dirty conditions. Also found were equipment soiled with greenish-yellow residue, according to inspection reports.