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GAO details ongoing problems with FDA’s lab safety oversight

GAO details ongoing problems with FDA’s lab safety oversight

The US Government Accounting Office (GAO) found that many elements of an effort to improve laboratory safety at the Food and Drug Administration (FDA) have not been met, over three years after establishing an Office of Laboratory Safety. For example, the safety oversight office still cannot perform unannounced laboratory inspections, according to the report.

Prompted by the 2014 discovery of boxes of smallpox virus that were improperly stored in a laboratory cold room maintained by FDA on the campus of the National Institutes of Health, GAO began an investigation that led to a series of five recommendations made in 2016 aimed at improving the agency’s laboratory safety.

As part of a strategic plan to address the GAO findings, FDA established an Office of Laboratory Safety (OLS), housed within the office of the FDA commissioner, in 2017. However, according to the GAO report, various branches of FDA still have not reached “a shared understanding” with OLS about the scope of the office’s oversight and responsibilities.

“Although senior agency leaders were involved in developing OLS’s strategic plan, disagreements about OLS’s role raised by center directors at that time still remain,” noted GAO in its summary of findings. On the one hand, center directors did not think that OLS oversight should include science, laboratory quality management or inspections. On the other hand, GAO investigators who spoke with the director of OLS, Segaran Pillai, PhD, learned that he still envisions OLS as having oversight over those areas, as the 2016 strategic plan had outlined.

The first of the new recommendations advises addressing the intra-agency disagreements. Though the strategic plan is scheduled for updating next year, a 2019 reorganization placed Pillai at an organizational level below that of center directors. Further, said GAO, OLS is not managing the staff who are responsible for implementing OLS-developed safety practices. “As a result, OLS has limited ability to access centers’ laboratories—in part because they cannot inspect them unannounced—or to ensure compliance with safety policies,” said GAO.

The funding structure at FDA has OLS drawing much of its support from the centers it oversees, a scenario that is problematic to GAO. The fact that OLS must annually enter into negotiations with center directors for funding means that it’s possible that center directors could “influence OLS priorities through the funding amounts they approve,” said GAO.

FDA has not investigated the extent to which centers hold sway over OLS because of these funding ties. Without taking steps to do so, FDA’s laboratory safety program will “continue to compete with the centers’ mission objectives and priorities,” said GAO.

GAO also recommends that duplication, overlap and fragmentation that currently exists within the safety program be addressed, and that FDA’s commissioner develop a clear and sustained communication plan that clarifies the role of OLS, and the overall importance of laboratory safety.

A fourth recommendation would have the Commissioner of FDA ensure that OLS has the authority necessary to conduct oversight of safety, including “access to laboratories” as required to conduct oversight and ensure compliance.

The funding structure at FDA has OLS drawing much of its support from the centers it oversees, a scenario that is problematic to GAO. The fact that OLS must annually enter into negotiations with center directors for funding means that it’s possible that center directors could “influence OLS priorities through the funding amounts they approve,” said GAO. FDA has not investigated the extent to which centers hold sway over OLS because of these funding ties.” Without taking steps to do so, FDA’s laboratory safety program will “continue to compete with the centers’ mission objectives and priorities,” said GAO.

Hence, the final GAO recommendation is to fund OLS through the FDA capital fund, to ensure the independence of OLS and sufficient staffing of its own to oversee and implement the safety priorities it identifies.

On 8 October, the same day the GAO report was made public, FDA Commissioner Stephen Hahn issued a statement on FDA efforts to ensure laboratory safety. He detailed efforts including a new cross-agency working group “to optimize and further foster a holistic, cohesive, and collaborative safety culture.” The effort, said Hahn, “is meant to strengthen the already robust safety measures that staff and senior leadership have implemented.”

Ongoing laboratory safety initiatives will be accomplished by collaboration between individual centers and offices and OLS, he said, affording the entire agency the opportunity to leverage the experiences of individual laboratories and other units within FDA.

In his statement, Hahn did not address specifics of the GAO report that recommended reorganization of funding and oversight hierarchy, nor did he specifically mention laboratory inspections.

Posted 09 October 2020

https://www.raps.org/

October 13, 2020 / Pharma News
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