Nearly 2,000 drug manufacturing plants are overdue for FDA inspections after COVID delays, AP finds
U.S. health inspectors are still struggling to address a massive backlog of pharmaceutical plants that went uninspected during disruptions caused by COVID-19
WASHINGTON — Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U.S. and across the world, The Associated Press has found.
An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections since before the pandemic, raising the risks of contamination and other issues in drugs used by millions of Americans.
The firms that are overdue for safety and quality inspections represent about 42% of the 4,700 plants that are currently registered to produce drugs for the U.S. and previously underwent FDA review before May 2019, the AP found. 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 “mandatory” inspections. Most of the overdue plants are in the U.S., but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost U.S. prescriptions.
“Generic drugmakers are under intense pressure to cut their costs and some will do that by cutting quality,” said David Ridley of Duke University, who studies the pharmaceutical industry. “If they’re not inspected, then we won’t know about it until — in a few tragic cases — it’s too late.”
Last year,
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