Tracking Major Changes at the FDA: Insiders Say Inspection Operations Could Be Impacted by Layoffs
The FDA is planning for fewer food and drug inspections due to layoffs, officials say.
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According to multiple recent reports, the FDA is facing significant challenges to its inspection operations due to staff cuts, resource constraints, and ongoing backlogs from the COVID-19 pandemic.
Here’s a brief synthesis of the most recent reporting.
Recent layoffs have impacted inspection support staff
On April 2, CBS News reported that senior FDA leaders are planning to reduce the number of routine food and drug inspections conducted by the agency due to layoffs of approximately 170 support staff from the Office of Inspections and Investigations (OII). While the HHS maintains that FDA inspectors themselves were not cut, the loss of administrative and management staff who supported these inspectors will likely cause major delays and disruptions.
"These administrative functions are being streamlined as part of HHS' transformation initiative to make the agency more efficient and responsive. FDA inspectors were not impacted and this critical work will continue," an HHS spokesperson stated.
However, former FDA officials interviewed by RAPS’s Regulatory Focus expressed concerns about these cuts:
"It makes the job of the investigator that much harder. They said they were not cutting the investigator and that's good, but if you're cutting the support around that, it's like the living version of the idiom 'penny wise and pound foolish.' If you're cutting the trip planner, for instance, they're the ones that set up everything for the investigator, especially the overseas trips," said Steven Lynn, who previously served as office director of the Office of Manufacturing Pharmaceutical Quality at the FDA's Center for Drug Evaluation and Research.
One of the most immediate impacts is the elimination of the office's travel operations division. This team was responsible for booking flights and coordinating with the State Department to secure translators needed for inspections abroad. According to a CBS News source, "As of yesterday, all front-line investigators will now be spending significant time processing their own travel and related administrative requirements, rather than spending that time in firms ensuring the American consumer is protected."
Compounding the existing inspection backlog
The layoffs come at a particularly challenging time as the FDA is still struggling with a significant backlog of inspections created during the pandemic. According to an AP analysis from September 2024, the agency had not returned to inspect roughly 2,000 pharmaceutical manufacturing facilities in the U.S. and more than 340 in India and China since before the pandemic.
A January 2025 report from the Government Accountability Office (GAO) found that the FDA has consistently failed to meet inspection targets:
The FDA has not met mandated targets for domestic food facility inspections since fiscal year 2018.
The agency has consistently fallen short of its annual targets for foreign food facility inspections.
FDA conducted an average of only 917 foreign food facility inspections per year—about 5% of its target of 19,200 inspections.
Flashback: Watch our 2021 interview with GAO’s Mary Denigan-Macauley, Director of Health Care, where she unpacked the pandemic-induced inspection backlog, and what measures the agency may take to address it:
Investigator shortages and turnover
A key challenge facing the FDA is an ongoing shortage of qualified investigators. According to the GAO, the FDA had a vacancy rate of around 16% among inspectors in 2024. The recent HHS layoffs may exacerbate this problem by making the already difficult jobs of FDA investigators even harder.