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Friday, April 12, 2013

FDA on hot seat over spinal meningitis outbreak By Megan R. Wilson - 04/11/13 06:11 PM ET


Lawmakers on the House oversight committee are looking into the ability of federal drug regulators to oversee compounding pharmacies.
Last month, the New England Compounding Center (NECC) in Massachusetts made thousands of tainted vials that killed 50 people and sickened more with the deadly spinal meningitis virus.
The House Energy and Commerce Subcommittee on Oversight will hear from Food and Drug Administration (FDA) Commissioner Margaret Hamburg on April 16 to examine whether the agency has the tools it needs to regulate the growing industry.
“The evidence so far demonstrates the NECC should have been shut down long before 50 people tragically lost their lives from contaminated injections,” said Rep. Tim Murphy (R-Pa.), the chairman of the subcommittee that will hold the hearing. “With many more still sick, we will continue investigating the breakdown at the FDA so a public health disaster like this one never happens again.”
More than 700 individuals have been sickened from the NECC contamination, and various other safety issues were found at compounding pharmacies in at least six other states, not including another in Massachusetts that prompted recalls of products.

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