U.S. health inspectors are still struggling to address a massive backlog of pharmaceutical plants that went uninspected during disruptions caused by COVID-19. That's according to an analysis of government data by the Associated Press.
An Associated Press analysis of FDA records found that government inspectors have not returned to nearly 2,000 factories due for a safety surveillance inspection. Commuters drive past the INTAS pharmaceutical manufacturing plant in Ahmedabad, India , Friday, Aug. 2, 2024, which had produced tainted eyedrops which sickened more than 80 Americans, killing four of them and blinding more than a dozen others. FILE - A U.S.
The agency’s work has been hampered by a wave of staff departures, he said, including longtime inspectors who have found new jobs that often allow them to work from home. “We have to recognize that this is the world we live in and we have to adapt to it,” said Dr. Stephen Ostroff, FDA’s former chief scientist. “That has to include being able to get into these facilities and take a look at what they’re doing, particularly in India and China.”The FDA keeps a confidential list of drug facilities to inspect, prioritizing them based on potential risks.
Nearly 90% of FDA’s foreign inspections in fiscal 2023 were announced in advance, according to FDA correspondence with Congress obtained via public records requests. The GAO and other government watchdogs have long raised concerns about the practice, which typically gives companies up to 12 weeks to correct or conceal potential problems.
The FDA currently has 225 vacancies on its inspection workforce, nearly four times as many as before COVID-19, according to agency records. For each one-week inspection, he said he might need another week or more to write up his report, particularly if he found serious violations. Hernandez says that extra time and attention to detail wasn’t always appreciated by his managers.
FDA says it’s exploring ways to make the jobs more attractive, including extra pay for experienced staffers and offering more flexible, comfortable travel arrangements.The slowdown in inspections has attracted scrutiny from lawmakers and raised new questions about whether FDA’s decades-old approach is working.
A pilot program requested by the U.S. Defense Department takes an alternative approach to monitoring the drug supply. The Pentagon is collaborating with a private laboratory, Valisure, to evaluate 40 prescription drugs critical to military personnel, testing them for contaminants, dosing and other issues. Initial findings from the two-year program found serious flaws in about 10% of a subset of drugs tested, according to results shared with the AP.
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