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.
“The U.S. drug supply is the safest on the planet and no other regulator conducts more inspections than the FDA,” said FDA Associate Commissioner Michael Rogers, noting that the agency has increased drug inspections each year since 2021 while prioritizing foreign factories. The FDA halted all but the most “mission critical” inspections in March 2020. It gradually restarted prioritized inspections later that year, but regular international visits did not resume until 2022.
The AP's tally of overdue plants also doesn’t include any of the new facilities that have registered with the agency since COVID-19 but haven’t yet had an initial inspection. FDA’s internal list of sites for inspection has increased 14% over the past five years, the agency noted last year. “If you do not prosecute people who do this kind of wrongdoing, it gives the implicit signal that the FDA will give companies a pass,” Thakur said.
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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