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

WASHINGTON (AP) — 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.

The FDA keeps a list of drug facilities to inspect annually, prioritizing them based on their potential risks. But the list is confidential, so the AP created its own list by compiling public records of FDA inspections before COVID-19 and tracking which firms haven’t received a follow-up.

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. The plants make hundreds of critical medicines, including antibiotics, blood thinners and cancer therapies.

Under FDA’s own guidelines, factories that haven’t been inspected in five or more years are considered a significant risk and are supposed to be prioritized for inspection.

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