Regulatory Focus™ > News Articles > Legislators Press FDA to Release Agency Materials Related to Meningitis Outbreak

Legislators Press FDA to Release Agency Materials Related to Meningitis Outbreak

Posted 19 November 2012 | By Alexander Gaffney, RAC

Republican legislators with the House's Energy and Commerce Committee, the committee charged with overseeing the US Food and Drug Administration (FDA), now say the agency has until 30 November to acquiesce to their demands for access to internal documents related to a recent outbreak of fungal meningitis.

The Energy and Commerce Committee's subcommittee on health has been investigating an outbreak of fungal meningitis, now understood to have been caused by contaminated vials of a steroid injection manufactured at the New England Compounding Center (NECC). FDA Commissioner Margaret Hamburg appeared before the committee on Wednesday, 14 November 2012, but received little sympathy from combative legislators.

During the hearing, legislators said they were "stunned" to learn of prior violations at NECC that had been noted by FDA, and pressed Hamburg for answers. She had few, noting at a subsequent panel that her lack of specific answers was driven in part by ongoing litigation against NECC and her desire not to negatively affect that case by making any premature or incorrect statements.

A New Effort to Obtain Documents

The hearing may be over, but now several prominent legislators are launching a new effort to get FDA to be more forthcoming.

In a letter sent to FDA on 19 November, Reps. Fred Upton, Cliff Stearns, Joseph Pitts and Joe Barton-all senior Republican members of the committee-referenced testimony made by Hamburg during the 14 November hearing.

During her testimony, recalled the representatives, "[Hamburg] asked that the Committee enact legislation to address perceived gaps in the ability of FDA to adequately protect the public from contaminated compounded products."

"Your request is a serious and important one, and we stand ready to work with you on identifying any such gaps, as well as better understanding whether existing authorities were used to their full capability," they added.

But the legislators lambasted what they referred to as inconsistencies in Hamburg's testimony, as well as FDA's reluctance to provide investigators with internal documents. The main question, they said, is, "Why FDA did not use its authority to take enforcement action against NECC until October 2012, after the meningitis outbreak." They noted that, since 2002, "FDA has initiated several inspection of NECC based on serious adverse events associated with contaminated drug products"-products that included the same one now blamed for the meningitis outbreak.

At various times, FDA asserted its authority to seize the products or shut down the manufacturing facility, but failed to do so. In the absence of action, legislators said they needed several points clarified. Among them:

  • Did FDA believe it had the authority to act when it said it did, or was that a baseless assertion?
  • Why did FDA not conduct follow-up inspections after finding contamination at the facility in 2004?
  • Did FDA even check with Massachusetts' state regulators to see if NECC was operating according to regulations?

"These are just a few of the key events and decisions the Committee has questions about," the legislators wrote.

"The Massachusetts Board of Pharmacy has provided the Committee with thousands of internal emails referring or relating to NECC," they added. "FDA has provided the Committee with zero. In fact, when asked by Committee staff on 6 November 2012, FDA staff stated that they had not even begun to search for responsive emails."

"Time is of the essence," concluded the letter, explaining that all documents should be sent to the committee by 30 October 2012 so that it can "immediately address your request for clearer and/or additional authority." The legislators noted this date is a month past their original deadline, but also now includes all memoranda and briefing materials related to the agency's use of enforcement discretion over compounding facilities since 2002. The original request only covered actions taken since 2004.


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