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Congressional Hearings Expand Meningitis/NECC Probe; More Light Shed on Regulatory Gaps

Nov 27th, 2012

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The Congressional investigation into the fungal meningitis outbreak caused by contaminated injectable methylprednisolone acetate (MPA) made and distributed by the New England Compounding Center (NECC) continued to expand in depth and breadth with a pair of hearings held in the House and Senate, respectively, in mid-November.

The hearings further revealed the intensity of the response to the current crisis at the state and federal levels and the intensity of the ongoing investigation into its causes. They also provided additional insight into the far-reaching implications of the drug quality control breakdown that stretch across the regulatory, political, legislative and health policy arenas. [See IPQ’s Special Report, “The Current Crisis in Pharmacy Compounding and its Implications.”]

Appearing at both the House and Senate hearings were FDA Commissioner Margaret Hamburg and Massachusetts Department of Public Health (MDPH) Interim Commissioner Lauren Smith.

Also appearing at the November 14 hearing of the House Subcommittee on Oversight and Investigations were NECC President Barry Cadden and Joyce Lovelace – the widow of Eddie Lovelace, a circuit judge who died Sept. 17 at Vanderbilt University Medical Center from a tainted injection compounded by NECC. Cadden declined to answer the questions the House committee posed to him, invoking his Fifth Amendment rights against self-incrimination.

Appearing before the Senate Health, Education, Labor and Pensions (HELP) committee the following day along with Hamburg and Smith were: ● Center for Disease Control (CDC) Director for Emerging and Zoonotic Infectious Diseases Beth Bell ● Tennessee Department of Health Director for Healthcare Associated Infections Marion Kainer ● International Academy of Compounding Pharmacy CEO David Miller, and ● American Society of Health-System Pharmacists VP Kasey Thompson.

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