GAO report on laboratory safety reports that FDA should strengthen oversight efforts

Oct. 9, 2020

The U.S. Government Accountability Office (GAO) released a report that examines the U.S. Food and Drug Administration’s (FDA's) efforts since GAO's 2016 report to improve safety in its laboratories that work with hazardous biological agents. 

The FDA has taken steps intended to improve safety at its laboratories, including those that work with hazardous biological agents. Specifically, FDA created the Office of Laboratory Safety (OLS) in 2017 as a safety oversight body for all FDA laboratories. In 2017, the Food and Drug Administration created a new office within the agency to oversee its lab safety program. But, three years later, there are still disagreements within the FDA about the office's roles and responsibilities. 

In 2014, FDA discovered improperly stored boxes of smallpox virus, posing a risk to individuals who might have been exposed. This raised concerns about the oversight of FDA's laboratories that conduct research on hazardous biological agents. In 2016, GAO made five recommendations to improve FDA's laboratory safety, four of which the Department of Health and Human Services (HHS) had not fully implemented as of July 2020. 

To conduct this work, GAO reviewed FDA documents; assessed FDA's safety oversight practices against key reform practices and oversight elements GAO identified in prior work; and interviewed FDA officials, including staff and senior leaders at OLS and the three centers that work with hazardous biological agents. 

GAO is making five recommendations to FDA, including to resolve disagreements over roles and responsibilities, to provide OLS with the authority and access to facilities necessary to oversee laboratory safety, and to take steps to assess and mitigate any independence risks posed by how OLS is funded. HHS agreed with all five recommendations. 

GAO has the report.

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