WASHINGTON (AP) — Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019,
WASHINGTON — 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.
Last year, tainted eyedrops from an Indian factory led to an outbreak of antibiotic-resistant bacteria that sickened more than 80 Americans, killing four of them and blinding more than a dozen others. The plant never registered with the FDA. 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.
The FDA’s struggles overseeing the global pharmaceutical supply have been documented by the “high risk” issue every year since 2009. 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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