FDA inspections slow as support staff layoffs strain overseas oversight

Editor's Note

Logistical staff layoffs at the US Food and Drug Administration (FDA) are hindering the agency’s ability to scrutinize drug manufacturing safety in foreign countries, according to a July 7 report in ProPublica.

A spokesperson from the US Department of Health and Human Services (HHS) told ProPublica that FDA inspectors “were not directly impacted.” However, current and former agency staff maintain that the loss of support staff, who arranged travel, managed budgets, coordinated translators, and provided other logistical services, has slowed the pace of inspections and made coordination significantly more difficult.

Nearly 70 employees responsible for inspection travel and logistics were laid off, the outlet reports, with only about one-third rehired. As a result, a small group of managers now handle complex international planning for inspections that can span weeks and cover multiple countries. 

As detailed in the article, HHS laid off more than 3,500 FDA employees—approximately 15% of the agency's workforce—in April. HHS Secretary Robert F. Kennedy Jr. said the move aimed to realign the agency around new priorities focused on reversing the chronic disease epidemic. Although HHS later reversed about 20% of the cuts agency-wide, it did not specify how many FDA employees would be reinstated.

Americans rely on overseas manufacturers for many generic drugs, including chemotherapy agents, sedatives, antibiotics, and emergency medications stocked on hospital crash carts, the outlet reports. Janet Woodcock, former head of the FDA’s Center for Drug Evaluation and Research, warned that removing support staff while retaining inspectors is akin to keeping doctors and nurses while eliminating the hospital lab techs and orderlies—essential infrastructure needed to maintain operations.

The Trump administration has said little about the cuts, although Kennedy recently told Congress that more than 900 CDC and NIH employees had been reinstated. Meanwhile, the FDA has pledged to expand unannounced inspections at overseas facilities and to implement a new AI tool, Elsa, to identify inspection targets. However, former Commissioner Margaret Hamburg cautioned that keeping the inspectors without restoring the systems that support will not ensure “safe and meaningful inspections."

The full report offers additional context, including details an anecdotes about inspectors’ working conditions and background on longstanding retention and other issues at FDA that predate recent layoffs.