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Congressional Committee Grills FDA Over Meningitis Outbreak

Filed November 15th, 2012 Laurie

On Wednesday, a congressional committee accused the U.S. Food and Drug Administration (FDA) of failing to prevent a deadly fungal meningitis outbreak by not taking action against the New England Compounding Center (NECC) quickly enough.

The U.S. Centers for Disease Control and Prevention (CDC) said 32 people have been killed and another 461 have been sickened by tainted steroids used to treat back pain that were produced at the pharmacy, and that number is expected to rise, since as many as 14,000 people have been exposed to the drug. Congress’s oversight and investigations panel is looking into why regulators took no action against NECC even though the pharmacy had numerous problems dating back to 1999. Among those problems were adverse reactions to a sterile steroid treatment as early as 2002, according to Reuters.

During a four-hour meeting, committee members accused FDA commissioner Margaret Hamburg of being unwilling to respond to questions about FDA authority and why it failed to take action against the NECC. Hamburg argued that conflicting court rulings and regulatory vagueness made it difficult for the FDA to regulate compounding pharmacies. In order to protect Americans in the future, she said, new laws must be passed to ensure that compounding pharmacies are regulated with the same standards as large drug manufacturers, Reuters reported.

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