Capitol Hill Hearing Examines Meningitis Outbreak

A subpoena ordered Barry Cadden, president and co-owner of the New England Compounding Center, to appear at the Nov. 14 hearing and testify.

Members of the U.S. House Energy & Commerce Committee's Oversight and Investigations Subcommittee waded into the fungal meningitis outbreak linked to contaminated injectable steroid medications from the New England Compounding Center (NECC) during a lengthy Nov. 14 hearing about the outbreak and whether it could have been prevented.

Many members pelted questions at Dr. Margaret Hamburg, FDA commissioner, asking whether her agency had the authority to shut down NECC's operations before this outbreak occurred. Hamburg steadfastly testified that a "patchwork" of laws and conflicting federal court decisions had limited FDA's authority. Several members asked her to turn over emails and records of past communications concerning NECC between FDA and the Massachusetts Department of Public Health, which has been jointly investigating Framingham, Mass.-based NECC with the FDA since Oct. 1.

Joyce Lovelace, the widow of Eddie Lovelace, 78, a circuit judge who died Sept. 18 after receiving one of the steroid injections at an outpatient surgical clinic in Nashville, and Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, also testified during the hearing.

As of Nov. 8, the death toll had risen to 32 and a total of 438 cases in 19 states, CDC reported. Twenty-three of the cases are in Florida, the home state of subcommittee Chairman Cliff Stearns.

The subcommittee posted a copy of the subpoena issued to Barry Cadden, president and co-owner of NECC, ordering him to appear at the hearing and testify. He invoked his Fifth Amendment right against self-incrimination in electing not to answer questions under oath about the causes of the contamination. The company has surrendered its license, shut down its operations, and recalled all of its products.

"NECC knowingly disregarded sterility tests, preparing medicine in unsanitary conditions and unlawfully engaged in manufacturing, endangering thousands of lives as a result," Smith stated in her prepared testimony. "NECC bears the primary responsibility for the harm they have caused with these actions." She discussed emergency regulations enacted in Massachusetts on Nov. 1 as a result of the inquiry and a special commission created to explore how best to strengthen state oversight of sterile compounding pharmacies.

Download Center

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program.

  • Job Hazard Analysis Guide

    This guide includes details on how to conduct a thorough Job Hazard Analysis, and it's based directly on an OSHA publication for conducting JHAs. Learn how to identify potential hazards associated with each task of a job and set controls to mitigate hazard risks.

  • A Guide to Practicing “New Safety”

    Learn from safety professionals from around the world as they share their perspectives on various “new views” of safety, including Safety Differently, Safety-II, No Safety, Human and Organizational Performance (HOP), Resilience Engineering, and more in this helpful guide.

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • EHS Software Buyer's Guide

    Learn the keys to staying organized, staying sharp, and staying one step ahead on all things safety. This buyer’s guide is designed for you to use in your search for the safety management solution that best suits your company’s needs.

  • Vector Solutions

OH&S Digital Edition

  • OHS Magazine Digital Edition - June 2022

    June 2022

    Featuring:

    • SAFETY CULTURE
      Corporate Safety Culture Is Workplace Culture
    • HEAT STRESS
      Keeping Workers Safe from Heat-Related Illnesses & Injuries
    • EMPLOYEE HEALTH SCREENING
      Should Employers Consider Oral Fluid Drug Testing?
    • PPE FOR WOMEN
      Addressing Physical Differences
    View This Issue