In the wake of the Covid-19 pandemic, the Food and Drug Administration continues to struggle with a lack of investigators needed to inspect domestic and foreign pharmaceutical manufacturing plants and has not yet developed a plan to keep needed staff, a U.S. government watchdog found.
Between November 2021 and this past June, the vacancy rate among investigators increased to 16% from 9%. Meanwhile, the FDA conducted 621 foreign and 444 domestic inspections in fiscal year 2023, down 36% from fiscal year 2019. The drop was attributed, in part, to the lack of investigators and a less experienced staff, according to a report by the U.S. Government Accountability Office.
A key reason for the high turnover is that some positions require travel that ranges from 25% to 75% of the time. Other issues were also cited, however, including compensation, training, workload, and work-life balance. And as the FDA relies more on inspections of European facilities by European regulators, its own investigators are increasingly taking longer trips to India and China.
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