House Republicans threaten to subpoena FDA over meningitis outbreak
Energy and Commerce Committee Republicans said that the FDA only has three weeks to turn over internal documents concerning oversight of the New England Compounding Center, the pharmacy at the center of the outbreak. NECC produced a contaminated batch of steroids, mainly to treat back pain, which is believed to have led to the deaths of 45 people. At least 600 fell ill, according to StarTribune.com.
The FDA inspected the pharmacy at least three times between 2002 and 2005. The agency ordered NECC not to mass-produce drugs outside of the scope of its license, but the facility was never shut down. The agency has turned over documents related to the inspections, but the House Republicans said they want to see internal memos as well.
A spokeswoman for the agency said that the FDA is working to respond to the legislators and has already turned over 3,500 pages of documents since the investigation began in October.
"These documents include correspondence from FDA's district offices and FDA headquarters as well as inspectional documents and adverse event records from the 2002-2006 timeframe," FDA Spokeswoman Erica Jefferson said, StarTribune.com reports.