Report: FDA Has Fallen Far Behind in Drug Plant Checks

Federal regulators responsible for the safety of the US drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the US and across the world. An AP analysis of Food and Drug Administration data shows that agency staffers haven't 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 US 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 the 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 US, but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost US prescriptions.
• "Generic drugmakers are under intense pressure to cut their costs, and some will do that by cutting quality," says 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."

• The FDA halted all but the most "mission critical" inspections in March 2020. It gradually restarted prioritized inspections later that year, but regular international visits didn't resume until 2022.
• "The US drug supply is the safest on the planet, and no other regulator conducts more inspections than the FDA," said FDA Associate Commissioner Michael Rogers, noting that the agency has increased drug inspections each year since 2021 while prioritizing foreign factories.
• Still, last year's inspection numbers were down almost 40% from the pre-pandemic period, when the FDA averaged around 4,300 annual inspections. Rogers offered no date for when the backlog of uninspected plants might be cleared. The agency's work has been hampered by a wave of staff departures, he said.

More here.

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