US FDA Needs Plan For Addressing Inspection Backlog Post-COVID, GAO Says
FDA also should more fully explore using alternatives to on-site inspections the pandemic prevents it from conducting, said Mary Denigan-Macauley, director of GAO’s health care office.
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Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.
FY2020 review highlights drop in inspections, preparations for growing backlog, and pandemic test of Janet Woodcock’s 21st Century proposition – developments that will likely reverberate in the years ahead.
GAO report offers new data on the impact of COVID on FDA’s drug inspections. (It was big.)