STAT+: FDA efforts to oversee foreign drug manufacturing remain inadequate to ensure safety, analysis finds
In the wake of the Covid-19 pandemic, the FDA inspected far fewer domestic and foreign pharmaceutical facilities, even though manufacturing activity did not decline, according to a new analysis.
In the wake of the Covid-19 pandemic, the Food and Drug Administration inspected far fewer domestic and foreign pharmaceutical facilities, even though manufacturing activity did not decline, according to a new analysis. Meanwhile, FDA budgeting and staffing held steady, although resources allocated for each inspection surged and more plants were cited for serious violations.
Specifically, there was a 79% drop in inspections of pharmaceutical manufacturing plants in foreign countries and a 35% decline in domestic facilities from 2019 to 2022. At the same time, the average number of inspectors assigned to inspections and the duration of each inspection increased in the U.S., Europe, India, and China, although there was a slight pullback last year in India and China.
The onset of the pandemic also marked a jump in the number of plants where FDA inspectors determined remedial action was required, rising to 27% of all domestic inspections in 2021 compared with 12% the previous year, although it fell back to 16% in 2022. For foreign facilities, about 17% of all inspections conducted the past two years yielded citations compared with just 5% in 2020.
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