WASHINGTON A U.S. House bill introduced following a meningitis outbreak tied to tainted drugs that killed 19 Michiganders and affected hundreds of others seeks to clarify federal authority over certain pharmaceutical providers.
But the measure stops short of expanding that authority as far as a proposal in the Senate.
The legislation introduced by U.S. Reps. Morgan Griffith, R-Va., Gene Green, D-Texas, and Diana DeGette, D-Colo. sets up a potential battle over the scope of authority the Food and Drug Administration would have to regulate so-called compounding pharmacies, one of which was the cause of the outbreak.
House sponsors balked at giving additional authority to the FDA under the bill, arguing as members did in oversight hearings with federal authorities that the agency failed to use its existing powers in reacting to earlier concerns at the New England Compounding Center in Masssachusetts before the outbreak last fall.
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My position on that has always been that the FDA had the authority, Griffith said. FDA should have known. ... The warning signals were all out there.
No state has been more affected by the meningitis outbreak that began last September than Michigan. The Centers for Disease Control and Prevention tracked 264 cases in the state. Nationally, there were 750 cases and 64 deaths in 20 states linked to fungal contamination of injectable steroids supplied by the NECC.
After the outbreak, the FDA stepped up enforcement actions against compounding pharmacies, a term traditionally applied to businesses that mix drugs for specific needs of a patient. More recently, its been applied to larger producers supplying compounds to hospitals and other health care practitioners that once made them in-house.
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Pharmacy fight looms in wake of meningitis outbreak