An office created in 2016 to ensure safety at labs has never been given the authorities necessary to do its job, GAO says.
The Trump administration is failing to provide adequate oversight to ensure employees at some federal laboratories are safe from COVID-19 and other dangerous pathogens, according to a watchdog report released on Thursday.
The Food and Drug Administration has yet to properly stand up a safety review office it created to address issues first identified in 2014, the Government Accountability Office found, creating safety risks in the midst of a global pandemic in which the agency is on the forefront of response efforts. FDA’s Office of Lab Safety lacks independence, proper authority, permanent staffing for inspections and agency-wide buy in, GAO said, preventing it from doing the job it was created to do.
“Until FDA fully addresses the challenges we identified, the integrity of FDA’s laboratory safety program and the agency’s ability to ensure the safety of laboratory personnel and prevent the accidental release of hazardous biological agents—such as the virus that causes COVID-19— will continue to be at risk,” the auditors said.
FDA launched the lab safety office to serve as “the central point of accountability for laboratory science and safety across the agency,” after officials discovered decades-old vials of smallpox in a storage room in 2014. The agency announced the office’s creation in 2016, but did not formally stand it up until early 2017. Its mission was to standardize safety practices at FDA’s 2,400 labs across 56 facilities and to provide oversight to ensure compliance with those standards.
While the Office of Lab Safety has taken some steps toward that goal by issuing guidance documents to standardize safety protocols, improving incident reporting of “near misses” and boosting safety training, GAO found that FDA has failed to clearly spell out the agency’s goals, address fragmentation and duplication and sustain the attention of leadership.
FDA officials who spoke to GAO took issue with the Office of Lab Safety’s roles, with facility directors saying the office’s jurisdiction should not include lab quality management or inspections. They said the office was wasting money and added no value to FDA’s mission. Other government inspectors could handle the safety office’s tasks, they told GAO, though the auditors said some overlap would help ensure no safety violations slipped through the cracks.
“Without resolving disagreements over [the office's] roles and responsibilities, addressing issues of duplication, overlap and fragmentation, and identifying how leadership will sustain communication about laboratory safety reforms,” GAO said, “FDA will be unable to ensure that [the office] can successfully oversee the agency’s laboratory safety program.”
Specifically, the Office of Lab Safety has limited authority to conduct investigations and reviews as it cannot conduct unannounced visits. Pre-announced inspections give FDA labs time to clean up and fix problems before the review takes place, GAO said. The office also sits below site directors in the organization chart, risking its independence and stymying its ability to actually enforce compliance with the safety policies it creates. In some cases, GAO found, safety office officials were denied entry to FDA labs altogether.
The Office of Lab Safety is also facing a funding crisis. President Trump slashed his request for the office in half in fiscal 2020 to just $2.5 million. Its funding has fluctuated since its creation, meaning the office has not been able to hire any permanent inspectors and currently has none on staff.
GAO recommended that FDA resolve disagreements within its ranks and address duplication and overlap. It also told the agency to improve communications, boost the safety office's oversight authorities and identify independent funding streams for the office. The Health and Human Services Department said it agreed with GAO and would address its suggestions as quickly as possible. FDA has been on the forefront of approving therapeutics and vaccines for the novel coronavirus.
FDA Commissioner Stephen Hahn said he has launched a working group to examine his agency's safety program and potentially reorganize reporting structures. Hahn said FDA is "committed to ensuring laboratory safety to protect our personnel and their research" and that OLS plays an important role in that effort. He added FDA will draw from GAO's recommendations and the findings from its own review to update the OLS strategic plan.
"Throughout the past months, as our agency has responded to the COVID-19 pandemic, I have seen the pivotal role many of our laboratories have played in responding, and I’m committed to ensuring that our laboratories continue to have the full support of FDA leadership to maintain this high level of excellence," Hahn said. "Safety and a commitment to scientific excellence remain at the core of the FDA’s mission and guide our work at our scientific research and analytical facilities and across all of our programs."
GAO noted FDA employees may remain at risk of dangerous exposures.
“Effective oversight of laboratories that work with dangerous pathogens is essential to preventing the release of hazardous biological agents that could expose laboratory employees and the public to serious and potentially lethal infections,” GAO said. “FDA must ensure that its laboratory safety program is effectively overseen in order to prevent such an occurrence.”
This story was updated with additional comment.
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