While the FDA’s inspection figures for drug manufacturing facilities have yet to fully recover from the COVID-19 pandemic, sweeping staff cuts have raised questions about how the agency plans to ensure drug quality with fewer resources.
Senior FDA leaders are anticipating that the agency’s already lagging rate of routine food and drug inspections will experience a downturn following HHS’ recent announcement that it’s cutting 10,000 jobs across the department, CBS News reported Wednesday, citing multiple FDA officials.
The HHS cuts, unveiled late last month, have so far claimed 3,500 full-time FDA positions and another 1,200 roles at the National Institutes of Health (NIH). The layoffs come on top of previous purges of probationary federal workers plus multiple high-profile departures at various federal health agencies.
At the FDA’s Office of Inspections and Investigations, around 170 workers have lost their jobs, according to CBS, which cited two anonymous federal health officials.
While HHS has said its mass downsizing effort will spare FDA inspection staff specifically, the regulator’s remaining leaders are struggling to avoid delays and disruptions given that the cuts did affect administrative and management workers who supported inspectors, CBS continued.
Take the FDA’s travel operations division, for instance. The division, which has now been eliminated, according to CBS, assisted with multiple tasks integral to inspection activities, such as booking flights and coordinating with the State Department to secure translators.
Now, front-line investigators will need to spend a “significant” amount of time processing travel and other administrative requirements, threatening further inspection delays, an unnamed FDA official told the news outlet.
Meanwhile, a pilot program focused on unannounced foreign inspections has also been put on hold following the cuts, CBS said.
An HHS spokesperson told Fierce Pharma on Thursday that the 170 layoffs mentioned in CBS’ reporting allude to administrative staff positions in the FDA, rather than inspectors themselves.
“These administrative functions are being streamlined as part of HHS’ transformation initiative to make the agency more efficient and responsive,” the spokesperson explained. “FDA inspectors were not impacted and this critical work will continue.”
Travel restrictions imposed during the COVID-19 pandemic severely hamstrung the FDA’s ability to carry out inspections of both food and drug facilities. While the agency’s drug manufacturing inspection figures have enjoyed a gradual upswing since 2020, those numbers are still well below pre-pandemic levels.
Out of 4,700 plants that make drugs for the U.S., 42% were overdue for inspection as of September, according to an Associated Press analysis of FDA data released last year.
With COVID restrictions now well in the rearview, one of the main issues currently facing the FDA is effectively attracting and retaining inspectors—a hurdle that will undoubtedly be made more onerous by the new HHS cuts.
“Post-pandemic, FDA saw a high turnover rate for investigators,” an FDA spokesperson told Fierce Pharma in September. “Many steps have been taken to decrease attrition and we continue to competitively recruit to fill vacant investigator positions.”
At the time, the spokesperson said that the agency’s hiring rates were outpacing the attrition in the drug inspection program.
Still, the FDA’s efforts to restore its former inspection prowess have failed to impress the Government Accountability Office (GAO), which issued a report in November urging the agency to take more aggressive steps to recruit and keep inspectors.
GAO, which essentially helps Congress investigate how the federal government spends taxpayer money, argued in its report that the FDA “has not yet developed action plans to fully address travel, workload, and work-life balance because potential solutions may not allow FDA to meet its inspection needs.”
The organization also warned that the “continued loss of experienced investigators” was hampering the agency’s ability to meet inspection goals.
GAO recommended that the FDA develop and roll out a plan addressing the remaining root causes of investigator attrition.