A Tough Time for FDA at House Hearings

Yesterday, FDA Commissioner Dr. Margaret Hamburg testified before the House Energy and Commerce Committee on the fungal meningitis outbreak. The purpose of the hearing was to determine why contaminated medicines entered the supply chain so that future occurrences could be prevented. Hamburg’s prepared statement focused on FDA’s response once the meningitis outbreak had occurred. The statement asserted that the laws governing compounding pharmacies, even large ones such as the New England Compounding Center (NECC), are ambiguous, thus limiting FDA’s ability to oversee such enterprises. In the statement, Hamburg requested legislation that would place nontraditional compounding pharmacies producing certain types of high-risk products under FDA oversight. The proposed legislation would allow FDA the same ability to inspect facilities and review records as the agency does for pharmaceutical manufacturers.

While Hamburg’s testimony was focused on the future, the representatives on the committee were visibly frustrated by her unwillingness to deconstruct the past, and identify steps that could have been taken to prevent the incident from occurring. Hamburg doggedly stuck to her explanation that FDA’s authority over compounding pharmacies was unclear. If FDA had no authority over large-scale compounding, this explanation might have been better accepted. However, FDA had issued warning letters to NECC in the past for matters not related to sterile manufacturing, and FDA certainly had the authority to inspect the facility and shut it down once the source of contamination had been identified.

Hamburg’s request for new legislation clarifying FDA oversight for nontraditional compounding pharmacies was well received, and I think we can expect to see such legislation in the near future. However, many of the committee members were clearly not satisfied that FDA had done everything it could, even considering its limited oversight responsibilities, to protect public health.

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