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As Meningitis Spreads, A Call for Drug Regulation

Filed October 10th, 2012 Laurie

As many as 13,000 patients may have been exposed to fungal meningitis after receiving a tainted spinal steroid injection. As of publication time, 11 people have died and 119 people in 10 states have fallen ill because of the pain injections.

The fungus made its way into the vials at a Framingham, Massachusetts compounding pharmacy known as the New England Compounding Center. The U.S. Food and Drug Administration (FDA) said federal officials there found a sealed vial containing so much of the contaminant that it was visible to the naked eye.

That’s why lawmakers want the government to be tougher on certain specialized pharmacies. Compounding pharmacies are not held to the same standards as big drug companies, and that makes using compounded drugs especially dangerous.

Lawmakers blame the outbreak on a lack of oversight of compounding facilities. Sen. Richard Blumenthal (D., Conn.), called for the FDA’s oversight authority to be extended to include the facilities, saying that compounding pharmacies’ “relative immunity from standards of safety and effectiveness seems anomalous and unacceptable.”

The FDA would be able to treat compounds as new drugs if they had full oversight over the pharmacies, which would force such pharmacies to submit clinical trials before the drugs are allowed on the market. The agency would also be allowed to inspect facilities.

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