A Government Accounting Office (GAO) report found that the U.S. Food and Drug Administration (FDA) Office of Lab Safety (OLS) does not have the authority it needs to effectively fulfill its oversight role at the agency.
In 2017, the FDA created the OLS to oversee safety at labs, including those that work with hazardous biological agents. The launch of the office followed the discovery in 2014 of improperly stored boxes of smallpox virus, which posed a risk to individuals who might have been exposed. The discovery also raised concerns about the oversight of FDA's laboratories that conduct research on hazardous biological agents.
But three years later, problems still exist, the GAO said. There are disagreements within the FDA about the office's roles and responsibilities and the lab safety program does not include key elements of effective oversight. For example, the OLS:
· cannot inspect labs unannounced
· director is at a lower level in the FDA organization than the directors of the agency’s operating divisions – known as centers
· does not directly manage the center safety staff responsible for ensuring the implementation of safety policies that OLS develops
· depends on the centers for much of its funding and has had to negotiate with the centers annually for those funds, which can compromise the safety program’s independence.
In the report, the GAO recommended that the FDA take steps to resolve these issues.
FDA Commissioner Stephen M. Hahn, MD, issued a statement in response to the report in which he said, “We plan to use the input from this GAO study, along with the results of a multi-phase effort led by the agency’s Office of Planning and Evaluation, to update the current OLS Strategic Plan, which will further ensure the success of a strong laboratory safety program.”
Hahn also said that he has launched a new cross-agency working group to review the agency’s current organizational structure and reporting relationships that support the agency’s occupational, health, environmental and laboratory safety programs.
