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…
The FDA considers plants that have gone more than five years without an inspection to be a significant risk.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.
But last year’s inspection numbers were still 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. In a statement, the FDA said that it receives inspection details from international partners, including European regulators, which help the agency decide whether a visit is necessary. The agency also began using video and other online tools to evaluate plants remotely during COVID-19, although those aren't equivalent to physical inspections.
The FDA said in a statement that it “must be judicious and apply a risk-based approach,” due to the “enormity” of its workload and limited budget.On a global basis, FDA says only 6% of sites inspected last year had serious problems. But rates are higher in India, where 11% of plants were cited for violations, the most of any country.
In the case of Intas, FDA issued a warning letter — which has no legal repercussions — and blocked some of the company’s exports to the U.S., while attempting to maintain shipments of the critical chemotherapy drug cisplatin. That strategy backfired in June 2023 when Intas abruptly shuttered the plant, triggering a nationwide shortage of cisplatin, which is used in more than a half-dozen cancers.
New inspectors generally start at an annual salary of about $40,000 and can eventually rise to over $100,000. Job postings alert applicants they may have to travel “up to 50% of the time.” “They just wanted people who are like bean counters: walk in, walk out and find nothing so that they can get this report through the system and make their numbers,” he said.
House Republicans have peppered the agency with dozens of inquiries about the program since 2023. In their most recent letter, members of the Energy and Commerce Committee ask regulators to explain why FDA staffers making high-priority inspections in Asia are reporting less than half as many violations today compared with pre-COVID-19.
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