Congress examines meningitis outbreak
AHA News Now
Nov 14, 2012
The House Energy and Commerce Committee today heard testimony from federal and state officials and relatives of victims of the recent outbreak of fungal meningitis. Contaminated drugs from the New England Compounding Center have been linked to 32 deaths and more than 438 illnesses. Food and Drug Administration Commissioner Margaret Hamburg, M.D., outlined the agency's response to the outbreak and steps the administration thinks are necessary to ensure FDA has the authority to oversee compounding pharmacies. "FDA's ability to take action against compounding that exceeds the bounds of traditional pharmacy compounding and poses risks to patients has been hampered by gaps and ambiguities in the law, which have led to challenges to FDA's authority to inspect pharmacies and take appropriate actions," she said before introducing a proposed framework for further oversight. Barry Cadden, president and co-owner of NECC declined to testify citing his Fifth Amendment rights. The Senate Health, Education, Labor and Pensions Committee will hold a separate hearing on the outbreak tomorrow.