The Government Accountability Office (GAO) issued a 67-page report that urges the FDA to begin implementing more aggressive steps to attract and retain inspectors in response to a shortfall of drug plant inspections during and following the global COVID-19 pandemic.
The agency, which is tasked by Congress to examine how the federal government spends taxpayer money, reviewed FDA records and found that in fiscal 2023 the regulatory agency conducted more drug plant inspections than it had since halting its regular process in March 2020. However, the FDA did not attain pre-pandemic levels of inspections last year.
Although the FDA conducted 1,065 total drug plant inspections in fiscal 2023—a 40% increase compared to the same period in 2022—it was 36% below the 1,671 the agency conducted in 2019 prior to the coronavirus outbreak, the GAO report said.
The FDA has previously said the decrease came partly because of reduced investigator capacity. And, in May, the regulatory agency said it had seen some progress with two pilot programs aimed at challenges it said were unique to foreign inspections: conducting unannounced inspections and utilizing independent interpreters.
“FDA has not yet developed action plans to fully address travel, workload, and work-life balance because potential solutions may not allow FDA to meet its inspection needs,” the GAO report said. “However, the continued loss of experienced investigators is already affecting FDA's ability to meet inspection goals.“
The GAO’s recommendation to the FDA is that it develop and implement a plan to address the remaining root causes of investigator attrition that balance agency needs against the need to retain investigators. The Department of Health and Human Services agrees with the recommendation, according to the GAO.
The number of investigator vacancies at the FDA increased from 25 in November 2021 to 51 as of June 2024, according to agency data cited by the GAO. The largest increase in vacancies across the FDA’s three groups of investigators was in the general pool of investigators who conduct both domestic and foreign inspections.
The GAO report comes in the wake of the Associated Press reporting in September that data it compiled from the FDA showed the agency has not attained pre-pandemic levels of plant inspections. The FDA said in response to the AP story that it has taken many steps to decrease attrition and will continue to aggressively recruit to fill vacant investigator positions.