Docs Reveal FDA Should Have Acted Sooner to Prevent Meningitis Outbreak - Stage Set for Tuesday Hearing with FDA Commissioner
WASHINGTON, DC – House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) today outlined the subcommittee’s focus for the panel’s Tuesday hearing to examine the deadly meningitis outbreak, which has resulted in 53 deaths and over 700 individuals sickened. FDA Commissioner Margaret Hamburg will provide testimony – she previously appeared before the Oversight and Investigations Subcommittee last November when the death toll stood at 32. The committee launched its investigation into the deadly outbreak in early October 2012, but the FDA did not begin to fully cooperate until March 2013, after the committee had announced it was considering a subpoena for FDA’s documents.
"We now understand why FDA was so reluctant in cooperating in our investigation and withheld the documents and information for months until we threatened to issue a subpoena. We know the actions of NECC and Ameridose led to 53 tragic and unnecessary deaths, and we know the FDA had ample opportunity to intervene before those tainted vials were ever distributed, but they did not do so," said Upton and Murphy. "We must learn from FDA’s mistakes of the past to ensure a similar public health disaster is not repeated. We owe it to the families who lost loved ones and those hundreds of Americans who are still sick and suffering who may never return to leading normal, healthy lives."
The documents produced by FDA establish the following facts about the agency’s history with NECC and its sister company, Ameridose:
- FDA has known for years that NECC and Ameridose were significantly engaged in drug manufacturing activities and operating well outside the bounds of traditional pharmacy compounding.
- FDA has also received a litany of complaints about NECC and Ameridose, a number of which directly involved the safety and sterility of the companies’ products.
- Information received by FDA about NECC and Ameridose, including complaints about the safety and sterility of their products, was not shared with state regulators.
Learn more about the committee's ongoing investigation here.
More information on Tuesday's hearing, "A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented," can be found here.