FDA Seeks Stronger Authority on Eve of Meningitis Hearings


David Morgan
Reuters
November 13, 2012

U.S. and state health regulators called on Congress on Tuesday to strengthen federal oversight of compounding pharmacies as lawmakers prepared for two days of hearings on a deadly fungal meningitis outbreak linked to a compounded steroid.

But the main federal regulator, the U.S. Food and Drug Administration, said in a statement to Reuters that it faces legal restrictions in regulating drug compounders such as the New England Compounding Center. The Massachusetts pharmacy was at the center of the outbreak that has infected 438 people, including 32 who have died, in 19 states.

The chief public health officer for Massachusetts also urged immediate congressional action to bolster federal oversight of the little-known, lightly regulated compounding industry, which is primarily overseen by state pharmacy boards.

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