FDA Faces Massive Inspection Backlog Amid Staff Departures, Raising Drug Safety Concern

SciFocus/Sept 11, 2024 -- The U.S. Food and Drug Administration (FDA) is grappling with a substantial backlog of pharmaceutical factory inspections, as a wave of staff departures hampers their ability to keep up with safety checks. More than 2,000 manufacturing plants, many producing essential medicines, have gone uninspected since before the COVID-19 pandemic. Experts warn that the delay raises the risk of contamination in drugs consumed by millions of Americans.

“Generic drugmakers are under intense pressure to cut their costs, and some will do that by cutting quality,” said David Ridley of Duke University. “If they’re not inspected, then we won’t know about it until—in a few tragic cases—it’s too late.”

Key Highlights:

- 42% of U.S. drug plants overdue for inspection: Out of 4,700 registered plants, 2,000 haven’t been inspected since before 2019.

- High-risk plants in China and India: More than 340 of these facilities are in India and China, the primary sources of ingredients for U.S. prescriptions.

- Staff exodus: FDA has lost key inspectors to private-sector jobs, further delaying inspections.

- Rise in drug recalls: Tainted products, including a notorious case of contaminated eyedrops from India, have caused severe health crises.

- Inspection backlog remains: FDA still struggles to reach pre-pandemic inspection levels, with no clear timeline for clearing the backlog.

- Video inspections introduced: During COVID-19, the FDA used remote inspections, but experts say they’re no substitute for in-person checks.

The FDA continues to prioritize the safety of the U.S. drug supply, but the ongoing challenges highlight the urgent need for reform in global pharmaceutical oversight.

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