The CBS report cites unnamed senior officials at FDA who said that approximately 170 support staff from OII were laid off last week, prompting the Agency to consider reducing the number of routine surveillance inspections in order to preserve capacity for higher priority inspections in response to safety issues and follow-up visits to troubled facilities.
FDA’s OII—formerly the Office of Regulatory Affairs — oversees the domestic and foreign inspections of drugs, medical devices, and foods and conducts 30,000 inspections per year. The Office was also restructured as part of the Agency’s modernization effort last year, which also saw the launch of its unified Human Foods Program.
An Health and Human Servivces (HHS) spokesperson told Focus that the layoffs mentioned in the CBS article relate to administrative staff positions. “These administrative functions are being streamlined as part of HHS’ transformation initiative to make the agency more efficient and responsive. FDA Investigators were not impacted, and this critical work will continue.”
Yet, an Agency official told CBS that OII will have to “reprioritize their workload for the rest of the year,” which would mean curtailing routine surveillance inspections.
A reduction in inspections could worsen the backlog of inspections as FDA recovers from the COVID-19 pandemic. During the pandemic, FDA Investigators could not inspect manufacturing facilities in person and had to rely on alternate tools, such as remote regulatory assessments. The Associated Press reported in September 2024 that the Agency is still struggling to catch up with inspections of about 2,000 drug manufacturing facilities in the US and more than 340 in India and China.
Two (2) former FDA officials who spoke to Focus described the staffing cuts as a mistake, indicating that these actions will further undermine the Agency’s inspection program. “It makes the job of the Investigator that much harder. They said they were not cutting the Investigator role 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 served as Office Director of the Office of Manufacturing Pharmaceutical Quality (OMPQ) at FDA’s Center for Drug Evaluation and Research (CDER) from 2011 to 2014 and is now the Executive Vice president for Regulatory Compliance Associates.
Lynn added getting rid of support staff places an added burden on the Investigators, who already have difficult jobs. “An Investigator, in my opinion, is probably the hardest job at the FDA. They are the face of the Agency. They’re the ones walking into a facility or a clinical trial site every day … It is also stressful. Imagine going into a different facility every couple of weeks where you are challenging Executive Leadership and saying, ‘prove to me that you are in control, and you can make this batch of product.’”
Another former senior official at CDER, who was granted anonymity due to fear of professional reprisal, told Focus the staffing cuts may hinder the Agency’s efforts to recruit Investigators and will also exacerbate the shortage of investigators. “GAO has issued one of their reports saying that the vacancy rate among inspectors last year was around 16%. The Agency was working really hard to fill those vacancies,” they said.
The Government Accountability Office (GAO) has been critical of FDA’s foreign inspection program in recent years. In 2022, GAO said the program is long due for an overhaul and in 2024 it issued a report that called on the Agency to create a better long-term plan for hiring and retaining Investigators.
The official further noted that “these were the kind of cuts to me that were not made by people who were well-informed about how the Agency operates.”
Steven Grossman, an FDA Regulatory Consultant and author of the FDA Matters blog told Focus that these cuts will significantly impact inspections. “The more important question is how many inspection teams are intact? Investigators do not work alone and what they produce is of limited value without other team members. Schedulers, security, and lab testing personnel have been mentioned, but the team also includes people who log, analyze, and act upon inspection reports,” Grossman said. He added that “it is a similar situation with reviewers — protecting reviewers is of limited value if you haven’t also protected review teams. A trained Investigator, a PhD biochemist, a biostatistician, a Consumer Safety Officer (CSO; otherwise known as an “FDA Investigator” that conducts field inspections), a communications specialist, and a laboratory technician are not interchangeable.”
REFERENCE: RAPS (Regulatory Affairs Professional Society) – Regulatory News; 07 APR 2025; Joanne S. Eglovitch