During a Senate confirmation hearing on Thursday, Dr. Martin Makary, President Trump’s pick to lead the Food and Drug Administration, addressed recent controversial staff reductions while pledging to conduct his own evaluation of the agency’s workforce needs.
The Johns Hopkins surgeon, responding to questions about hundreds of FDA employee terminations ordered by the Department of Government Efficiency, indicated he wasn’t involved in those decisions but promised to ensure staff would receive necessary resources to perform their duties effectively.
When questioned by Maryland Democratic Senator Angela Alsobrooks, whose district includes FDA headquarters, Makary emphasized his support for career FDA professionals while committing to perform an independent staffing assessment if confirmed. However, he also noted the significant expansion of FDA personnel, pointing out that employee numbers have doubled to approximately 19,000 since 2007.
This growth comes as pharmaceutical company user fees, which support FDA review activities, have more than tripled during the same period. The agency has also implemented new fee structures for expediting generic and biosimilar drug evaluations, while expanding into emerging fields like artificial intelligence and genetic medicine.
Republican Senator Susan Collins of Maine raised concerns about the targeting of probationary employees, highlighting the FDA’s ongoing need to recruit new scientific talent as veteran staff retire. Collins emphasized that over half of FDA employees are funded through industry user fee agreements, questioning whether Makary would maintain full authority over staffing decisions.
Democratic Senator Tim Kaine of Virginia criticized the broad approach to layoffs, particularly the focus on probationary employees with fewer protections. When asked about implementing more strategic personnel decisions moving forward, Makary responded by referencing his surgical background.
The pharmaceutical industry has largely remained quiet regarding the agency layoffs, despite the cuts affecting staff whose work is partially funded through industry fees. However, BIO chief John Crowley recently cautioned against continuing with unfocused staff reductions in a Stat opinion piece, arguing that recent government reform efforts lacked strategic insight for modernizing healthcare agencies.
The impact of these changes has caught the attention of financial analysts, with RBC Capital Markets’ Brian Abrahams noting investor concerns about potential disruptions to FDA review processes and regulatory flexibility due to staff attrition.
The layoffs have particularly affected certain departments, including device staff working on artificial intelligence initiatives, though some employees have reportedly been rehired. The exact number of reinstated workers remains unclear.
The staffing reductions come at a time when the FDA faces increasing responsibilities in overseeing technological advances in healthcare and drug development. The agency has been working to build expertise in emerging fields while maintaining its core regulatory functions.
The situation highlights ongoing tensions between government efficiency initiatives and the need to maintain adequate staffing levels at critical regulatory agencies. As the FDA continues to adapt to evolving healthcare technologies and drug development approaches, the balance between fiscal responsibility and maintaining necessary expertise remains a central challenge.
Makary’s confirmation hearing responses suggest a measured approach to addressing these staffing challenges, emphasizing both the importance of career staff and the need to evaluate current personnel levels. The outcome of his proposed independent assessment, should he be confirmed, could significantly influence the agency’s future staffing structure and its ability to fulfill its expanding regulatory responsibilities.