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Nearly 2,000 drug manufacturing plants overdue for FDA inspections post-COVID
Industry News- Sep 06,24
These overdue inspections affect about 42% of the 4,700 registered drug manufacturing plants that were reviewed by the FDA before May 2019.
The U.S. Food and Drug Administration (FDA) is grappling with a significant backlog of pharmaceutical manufacturing inspections, still recovering from disruptions caused by the COVID-19 pandemic. An analysis reveals that roughly 2,000 drug manufacturing facilities have not been inspected since before the pandemic, raising concerns about potential risks in drugs used by millions of Americans.
These overdue inspections affect about 42% of the 4,700 registered drug manufacturing plants that were reviewed by the FDA before May 2019. The facilities in question produce critical medicines, including antibiotics, blood thinners, and cancer treatments. According to FDA guidelines, factories that have not been inspected in over five years are deemed high-risk and should be prioritised for mandatory inspections. While most overdue facilities are based in the U.S., over 340 are located in India and China, key sources of drug ingredients for the U.S.
David Ridley, a pharmaceutical industry expert from Duke University, highlights the risks of delayed inspections. “Generic drugmakers are under intense pressure to cut costs, sometimes at the expense of quality. If these plants aren’t inspected, we may only discover problems when it’s too late,” he said.
The FDA's inspection capacity has been hindered by a wave of staff departures and an increased workload. The agency had suspended all but the most critical inspections in March 2020, resuming prioritised inspections later that year. Regular international inspections did not resume until 2022. Despite efforts to increase inspections, last year’s numbers were still nearly 40% below pre-pandemic levels.
FDA Associate Commissioner Michael Rogers noted that the agency has been working to address these challenges, including using remote tools and collaborating with international partners. However, the backlog remains substantial, with inspection numbers in India and China particularly concerning. India alone has 160 overdue plants, and China, with its political tensions, has around 185 overdue facilities.
The FDA has faced criticism for its approach, including the practice of notifying companies in advance of inspections, which can give them time to address or hide issues. Despite the challenges, the FDA insists it prioritises inspections based on risk and remains committed to ensuring drug safety.
Former FDA inspector Jose Hernandez and other experts suggest that the agency could benefit from reforming its approach, including possibly incentivising drug purchasers to prioritise high-quality manufacturers. As the FDA continues to address its backlog and adapt to the evolving landscape, there is growing debate about whether one agency can effectively oversee the global drug manufacturing sector.
(The Associated Press)
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