House Committee Members Examine FDA’s Responsibilities Relative to the Meningitis Outbreak
In a meeting last week, members of a House Energy and Commerce subcommittee stressed that Food and Drug Administration (FDA) could have done more to prevent the fungal meningitis outbreak that killed 53 people and sickened hundreds in late 2012. During an April 16 hearing, Oversight and Investigations Subcommittee members questioned FDA Commissioner Margaret A. Hamburg, MD, about the agency’s response to complaints and other information about the New England Compounding Center (NECC), which was found to be the primary source of contaminated drugs. Video of the committee members’ questions and Hamburg’s responses, along with a link to the committee’s report, is available on the House Energy and Commerce Web site. In the wake of the meningitis outbreak, Hamburg has called for the development of legislation to establish appropriate, minimum federal standards for entities, such as NECC, engaged in the compounding of non-patient-specific sterile drugs for interstate distribution.