FDA Should Improve Lab Safety Oversight: GAO

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The Government Accountability Office (GAO) says FDA should take additional steps to strengthen efforts to provide effective laboratory safety oversight. A GAO report says it examined FDA efforts since 2016 to improve safety in its laboratories that work with hazardous biological agents.

An initial GAO report in 2016 made five recommendations for improving FDA laboratory safety, four of which were not fully implemented as of 7/2020, the report says.

GAO recommends that FDA: 

  •          resolve disagreements over roles and responsibilities;
  •          address issues of duplication, overlap, and fragmentation in the safety program;
  •          identify how FDA leadership will communicate agency-wide on a sustained basis about the importance of laboratory safety and the Office of Laboratory Safety’s (OLS) role in ensuring successful implementation of laboratory safety reforms;
  •          provide the OLS with the authority and access to facilities necessary to oversee laboratory safety and ensure compliance with agency safety policies; and
  •          mitigate any independence risks posed by how OLS is funded.

HHS agreed with all the recommendations, the report says.

 

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