• The FDA is reversing some layoffs, reinstating staff in drug and food safety labs and those who book travel for foreign inspections, following disruptions to key operations.
• Layoffs have led to delays in FDA inspections, drug safety work, and confusion regarding the status of risk evaluation and management programs (REMS) for certain drugs.
• Concerns remain about the overall impact of the cuts on the FDA's ability to perform its core functions, as well as potential for further staff departures due to a morale decrease.

The Food and Drug Administration (FDA) is experiencing turmoil following recent layoffs intended to reduce the agency's workforce. These cuts have led to disruptions in critical functions, including drug and food safety inspections, drug safety monitoring, and responses to public inquiries. After pushback and identified operational failures, the FDA has decided to reverse some of the layoffs, reinstating specific staff positions. The situation raises concerns about the FDA's ability to effectively oversee public health and safety, especially regarding drug approvals and safety monitoring.

• What: The FDA is partially reversing layoffs that caused disruptions in drug and food safety inspections, drug safety monitoring, and access to public information. Specific instances include reinstating travel booking staff for foreign inspections, food scientists, and drug safety lab scientists.
• Who: Key individuals include FDA Commissioner Marty Makary, HHS Secretary Robert F. Kennedy Jr., affected FDA employees, health-care providers, and drug manufacturers. Organizations include the FDA, HHS, Centers for Disease Control and Prevention (CDC).
• When: Layoffs occurred around April 1, 2025. Reversals of some layoffs began in late April/early May 2025. There were February 2025 layoffs also.
• Where: The layoffs and their reversals affect FDA operations nationally, including labs in Puerto Rico, Detroit, Chicago, San Francisco, New York and Irvine, California, as well as foreign inspection operations.

The FDA's recent layoffs and subsequent reversals reveal a tumultuous period for the agency. Initial cuts aimed at streamlining operations have instead led to significant disruptions in key functions, including drug safety monitoring, inspections, and public information dissemination. While the reinstatement of some employees addresses immediate operational concerns, the broader impact on staff morale, agency effectiveness, and potential for a 'revolving door' dynamic with the pharmaceutical industry remain causes for concern. The situation highlights the complex challenges of balancing budgetary constraints with the critical need to maintain robust regulatory oversight of the food and drug industries.

"This is exactly why HHS is reorganizing its administrative functions to streamline operations and fix the broken systems left to us by the Biden Administration. Streamlining this into one operation will allow for enhanced data integrity and coordination,"

"when you don’t have good postapproval monitoring, as this agency has not had, you discover things decades later."

"I hope Commissioner Makary continues to assess these ill-informed cuts and works to bring back impacted employees expeditiously. His legacy as commissioner is on the line."

The FDA's decision to reverse some layoffs signals a recognition of the detrimental impact of the cuts on the agency's ability to fulfill its core mission. While the reinstatement of staff in critical areas provides some relief, the long-term consequences of the turmoil remain uncertain. Ongoing monitoring of the FDA's performance, staff morale, and ability to ensure drug and food safety will be essential to assess the full impact of these events.