FDA drug-plant inspections still haven’t recovered from the pandemic, AP reports

The FDA has not inspected nearly 2,000 drug manufacturing plants since before the COVID-19 pandemic, with about 42% of the firms currently registered to produce drugs for the U.S. overdue for inspection. These plants make critical medicines such as antibiotics, blood thinners, and cancer therapies. The FDA prioritizes facilities that pose the greatest risk to the public, but it has been using online tools and information from European regulators to supplement its efforts. Despite ramping up inspections since 2021, the FDA still isn't inspecting at the level it was before COVID-19, with last year's inspection numbers down 40% from the prepandemic period. The agency's work has been slowed by attrition, with a wave of departures before and after the pandemic leaving the FDA with a less-experienced workforce. FDA staffers are uncovering serious problems as they return to overseas plants, including violations at Intas Pharmaceuticals in India. The FDA still has more than 220 vacancies among its inspection workforce, with the inspection team only 85% staffed compared to over 95% in fiscal 2019. The FDA has been trying to recruit more inspectors but has struggled to fill the positions. The FDA maintains that the U.S. drug supply is "the safest on the planet," but the backlog of uninspected plants raises concerns about the quality of drugs being produced.