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.

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OH&S Digital Edition

  • OHS Magazine Digital Edition - June 2022

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