5 takeaways from AP’s report on the big backlog of uninspected drug factories
6 months, 1 week ago

5 takeaways from AP’s report on the big backlog of uninspected drug factories

Associated Press  

WASHINGTON — As COVID-19 swept across the globe in early 2020, the Food and Drug Administration pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical plants in the U.S. and overseas. Nearly five years later, The Associated Press wanted to assess the FDA’s performance in catching up on inspections of factories that produce drugs used by millions of Americans. Here are five takeaways from the AP’s exclusive story: The FDA hasn’t returned to roughly 2,000 drug manufacturing plants since before the pandemic The overdue drug plants identified by the AP represent about 42% of the firms that are currently registered to produce drugs for the U.S. and previously underwent FDA surveillance inspections before May 2019. FDA officials say the U.S. drug supply is “the safest on the planet.” Because of its enormous inspection workload, the agency says it prioritizes facilities that pose the greatest risk to the public. “We continue to increase their experience and training to get this group of investigators up to the same level we were able to utilize pre-pandemic.” Vacancies persist among FDA’s workforce Despite years of recruitment efforts, the FDA still has more than 220 vacancies among its inspection workforce, according to agency records obtained by the AP.

History of this topic

FDA has massive backlog of factory inspections as staffers leave for private sector jobs
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