Pharmaceutical and medical device manufacturers should not assume that recent staff cuts at the US Food and Drug Administration (FDA) mean the agency will inspect less often and take fewer enforcement actions, according to a panel of experts who spoke at a Food and Drug Law Institute (FDLI) webinar on 01 MAY 2025.
They also noted that the Agency can continue to utilize its existing alternative tools to assess Good Manufacturing Practice (GMP) compliance, such as record reviews and remote interactive evaluations, and predicted that the FDA’s unannounced foreign inspections pilot –which has reportedly been paused – will resume later this year. The latter assessment was based on a recent comment by FDA Commissioner Martin Makary that foreign firms are “held to a much lower inspection standard than US facilities.”
The panel included Donald Ashley, Principal for Regulatory Compliance at Eliquent Life Sciences. Ashley was the former Director of the Office of Compliance at the Center for Drug Evaluation and Research (CDER). Ashley discussed how the Trump Administration’s reduction in force (RIF) effort will impact medical product inspections. In APR 2025, the administration laid off some 3,500 FDA staff, including.
In April 2025, the administration instituted a RIF which resulted in the elimination of 3,500 FDA employees, primarily affecting administrative, policy, and communications staff. Among those let go were numerous staff responsible for managing travel arrangements for inspection personnel, said Ashley. He also pointed to recent reporting that indicates FDA plans to rehire some of its recently laid off inspection logistics staff.
Another troubling trend is the vacancy rate among FDA Drug Investigators increased from 9% in November 2021 to 16% in June 2024, with the continued loss of experienced investigators. He said that attrition has been a problem since COVID-19, and the new administration’s actions are prompting the departure of more investigators. Ashley said that senior leaders with the Office of Inspections and Investigations (OII) have already left the Agency. For example, Alonza Cruse, the longtime Director of the Office of Pharmaceutical Quality Operations has reportedly retired.
Due to these capacity challenges, Ashley noted that the FDA is conducting “substantially fewer” drug establishment inspections compared to before the COVID-19 pandemic. In FY 2019, the FDA conducted approximately 1,300 drug quality inspections. However, this number dropped to about 550 inspections in FY 2020, and it remained low at around 250 inspections in FY 2021. In FY 2022, the number of inspections increased to about 550, and in FY 2023, the FDA conducted nearly 800 of these inspections.
Yet, Ashley reminded the webinar participants to consider the context of these developments, noting that the current turmoil at FDA is not as severe as the challenges faced by the Agency during the COVID-19 pandemic. “While the latest leadership departures and staff reductions of the FDA are concerning, they do not rise to the level of disruption the COVID-19 pandemic posed to the FDA’s ability to conduct inspections. Consequently, we do not expect to see an equivalent level of disruption to FDA’s inspections.” Despite these trends, Ashley urged the audience to remain prepared and to “maintain inspection readiness.”
To offset a potential decrease in onsite surveillance initiatives, FDA is likely to enhance its use of alternative measures, he said. This may include requesting records under Section 704(a)(4) and conducting remote inspections as alternatives to traditional inspections. In the foreign inspection realm, Ashley noted that FDA’s unannounced foreign drug facility inspection program in India was suspended temporarily following the recent layoffs.
Commissioner Makary has publicly questioned why foreign drug manufacturers are held to a lower inspection standard. This suggests that Makary will push for more unannounced foreign facility inspections once the travel issues are resolved, said Ashley. Ashley also advised companies to treat any record request with the same level of seriousness to prepare for an on-site inspection. FDA frequently issues Warning Letters regarding information received through such requests, and a poorly prepared request could result in a Warning Letter.
Industry agrees with Ashley’s assertion that companies should be prepared for inspections at any time. Companies should not assume that a decrease in resources indicates a lack of inspections and enforcement. He advised companies to ensure they are ready for FDA inspections by creating readiness plans and conducting mock inspections. Additionally, companies should consider hiring a third party to assess readiness to provide an unbiased perspective.
Important changes to inspection processes in the medical device sector are on the horizon, and companies must remain vigilant. The Quality Management System Regulation (QMSR) updates the FDA’s requirements for medical device quality systems outlined in Part 820. There is a two-year transition period that will end on 2 February 2026. Ashley recommended that companies assess their Quality Management System (QMS) against the QMSR requirements and make necessary adjustments before the implementation deadline.
REFERENCE: Regulatory Focus (News and Peer Reviewed Content) – Regulatory News; 05 MAY 2025; Joanne S. Eglovitch