Friday, February 8, 2013

Committee Leaders Set Final Deadline for FDA to Provide Documents Related to Deadly Meningitis Outbreak

WASHINGTON, DC – After repeated requests for cooperation and months of delay, Republican leaders of the House Energy and Commerce Committee today set a final deadline for the Food and Drug Administration to provide documents relevant to the deadly meningitis outbreak and the agency’s history with the New England Compounding Center (NECC). Committee leaders first requested all documents related to FDA's oversight of NECC in mid-October. During a November 14, 2012, Oversight and Investigations Subcommittee hearing, FDA Commissioner Margaret Hamburg repeatedly assured members her agency would provide the documents, but the agency still has failed to comply.
“The committee has a long, bipartisan history of conducting oversight of our nation’s drug supply, and we hope a subpoena will not be necessary for the FDA to cooperate and help us determine what went wrong,” said Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA). “With 45 innocent lives lost and hundreds fallen ill during the outbreak, the FDA's lack of urgency is troubling, and the committee will not tolerate any more delays. This issue is too important and too urgent. The public has a right to know what happened, and deserves the peace of mind that will come from knowing the problem has been identified and fixed. We expect the FDA to cooperate so we can work together to ensure it never happens again.”
Since the committee first requested documents relevant to the outbreak and the agency’s history with the NECC, the FDA has produced past inspection reports and formal correspondence with the company, most of which had already been made publicly available. To date, FDA has produced no internal communications from the critical time period of 2002 through 2006, when FDA conducted three separate inspections of NECC’s facilities, documented numerous public health and safety concerns, and considered enforcement actions against the firm. The FDA has also failed to produce any communication from staff and officials at FDA headquarters who were making decisions related to the situation.
In the letter to FDA Commissioner Margaret Hamburg, full committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), Subcommittee Vice Chairman Michael C. Burgess, M.D. (R-TX), Chairman Emeritus Joe Barton (R-TX), and full committee Vice Chairman Marsha Blackburn (R-TN) wrote, “The few communications FDA has produced to the committee from the account of one district office employee raise new and troubling questions about the agency’s oversight of NECC after the December 2006 Warning Letter up until the recent outbreak, including why FDA failed to re-inspect the company’s facility.  FDA’s repeated inaction is even more troubling in that it runs counter to remarks you gave early in your tenure during a speech entitled, ‘Effective Enforcement and Benefits to Public Health.’  In that speech, you noted the need to ‘follow-up on signals indicating problems’ and promptly ‘assess whether or not a company has made required changes in its practices.’  In order for the committee to fully understand why FDA never re-inspected NECC or took any meaningful enforcement action against the company, despite repeatedly asserting that it could and would do so, the agency must cooperate with the committee’s investigation and fully respond to our request for internal communications and memoranda."
The members concluded, “FDA has not provided a valid reason to the committee for continuing to withhold these documents. If FDA does not produce all the responsive documents by 5:00 p.m. on February 25, 2013, the committee will move forward with a business meeting to compel their production.”
Read the full letter online HERE.
Source found here 

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