Meningitis Outbreak: FDA Chief Grilled At Congressional Hearing As New Documents Emerge

By Toni Clarke
WASHINGTON, April 16 (Reuters) - The head of the U.S. Food and Drug Administration conceded on Tuesday that the agency could have been more aggressive in its oversight of the compounding pharmacy at the center of a deadly meningitis outbreak.
Testifying at a contentious congressional hearing, FDA Commissioner Margaret Hamburg said a confusing legal landscape, combined with resistance from compounding pharmacies, had hampered her agency's ability to act on a myriad of complaints against the New England Compounding Center and its sister company, Ameridose LLC.
"I wish we had acted earlier," Hamburg told a House Energy and Commerce subcommittee looking into the outbreak, which has killed 53 people and sickened more than 700.
The hearing was the second held by the committee to determine whether the FDA could have prevented the outbreak and whether it needs greater powers to regulate pharmacies that compound drugs tailored for specific patients. In the past decade, some have come to operate more like traditional pharmaceutical manufacturers, but without the same oversight.
Hamburg said the current legal framework "does not provide FDA with the tools needed to identify and adequately regulate these pharmacies to prevent product contamination." She asked Congress to allow the FDA to require compounding pharmacies to register with the agency "so we know who they are and what they do."
Hamburg also would like to ensure a consistent set of safety regulations that would require compounding pharmacies to report any problems associated with their drugs.
"We are hopeful that the Senate will come out with a legislative proposal soon," said Steven Immergut, an FDA spokesman.
Drawing on roughly 30,000 pages of documents turned over by the FDA, committee members honed in on the agency's decision, in 2011, to stop initiating inspections of compounding pharmacies until it had finalized new guidance designed to clarify how it would regulate the industry in the face of a complex set of legal decisions dating back years.
The FDA has not made the documents public, saying they are part of the criminal investigation into NECC and Ameridose.
But separate reports prepared by Republican and Democratic staff portray an agency that has struggled for nearly a decade to enhance its authority over compounding pharmacies while simultaneously failing to fully exercise the authority it has.
According to the documents and comments from committee members at the hearing, the FDA received a steady series of complaints about NECC even after the agency issued a warning letter to the firm in 2006.
Documents cited by committee members indicate the FDA considered additional inspections and possible enforcement actions but felt it could not take them because it had not responded, two years later, to NECC's reply to the warning letter.
In addition, according to the Republican report, some compliance officers began to fear that the agency's lack of response to NECC might hinder further regulatory action against it. The indecision apparently frustrated agency compliance officers.
"Documents to the Committee reveal that FDA staff was frustrated with the time it was taking the FDA Chief Counsel's Office to approve a response to NECC," the report said.
A similar pattern of delays and uncertainty appears to have plagued the FDA's investigation of Ameridose, which it inspected in 2007 and 2008, finding numerous causes for concern. According to the documents cited in the Republican report. The FDA spent months drafting a warning letter to Ameridose before finally deciding not to issue it, citing conflicting court rulings related to pharmacy compounding.
Documents viewed by committee staff indicate that ultimately the FDA in 2011 decided not to pursue inspections while it finalized new guidance, though Hamburg told the Committee the agency did conduct investigations if an issue was brought to its attention.
Her answer raised questions among some committee members.
Colorado Democrat Diana DeGette asked Hamburg why the agency could not continue to conduct investigations and at the same time as finalizing its guidance.
John Taylor III, who counsels the FDA commissioner and was present at the hearing, said the agency was fearful that if it tried to inspect pharmacies before it had finalized its guidance it would be sued by compounding pharmacists and lose, potentially undermining the agency's authority further.
The report prepared by Democrats point to an intense lobbying effort by the compounding industry to prevent the FDA from increasing its oversight. And committee members stressed the complicated legal framework under which the FDA is attempting to regulate compounders.
"FDA struggled to pick up the pieces of a statute in tatters, said California Democrat Henry Waxman. "It is Congress's job to fix the law when it is inadequate or the courts invalidate it. Which is why we must do more than blame the FDA but give it the clear authority it needs." (Reporting By Toni Clarke; Editing by Ros Krasny and David Brunnstrom)

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Source: http://www.huffingtonpost.com/2013/04/17/meningitis-outbreak-fda-chief-documents-congressional-hearing_n_3096257.html

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