Set Nov. 30 Deadline for Agency to Comply and Turn Over Internal Docs
WASHINGTON, DC – House Energy and Commerce Republican leaders late last week requested the Food and Drug Administration provide internal documents related to the deadly meningitis outbreak by November 30, 2012. While testifying before the Oversight and Investigations Subcommittee, FDA Commissioner Margaret Hamburg repeatedly assured members her agency would provide the documents, which were originally requested one month ago, in a timely manner.
In the letter to Commissioner Hamburg, full committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Chairman Cliff Stearns (R-FL), Chairman Emeritus Joe Barton (R-TX), Health Subcommittee Chairman Joe Pitts (R-PA), and Rep. Michael C. Burgess, M.D. (R-TX) wrote, “In order to effectively and responsibly address the question of clarifying or enhancing FDA’s authority over compounding pharmacies, the committee must identify what happened at the New England Compounding Center (NECC), and why FDA did not use its authority to take enforcement action against NECC until October 2012, after the meningitis outbreak. Your agency has not provided any internal communications or memoranda in response to the committee’s bipartisan request letter of October 17, 2012. We need these documents to identify any possible weaknesses in FDA’s regulatory system that can be immediately corrected administratively or legislatively. Without gaining insight into whether FDA used its existing authority effectively, providing clearer or additional authority to FDA may not solve the actual, underlying problem…”
The members continued, “This committee has a long history of thoroughly and deliberatively investigating problems and offering solutions. We cannot and will not be in a position to do so in this instance until we have a full accounting of FDA’s past actions and decisions relating to NECC and the reasoning behind them. Time is of the essence. We need the FDA to be fully cooperative and prompt in its response so the committee can immediately address your request for clearer and/or additional authority.”
A copy of the full letter is available HERE.