In Simple Terms
This article discusses the challenges faced by the FDA after many employees were let go during Trump’s presidency. Three former FDA leaders talk about the need to regain trust and bring back experienced staff to work effectively in the future.
Challenges for the FDA
At the 2026 STAT Summit in Boston, three former FDA commissioners expressed concerns about the agency’s future following significant staff reductions. Robert Califf, Scott Gottlieb, and Ned Sharpless highlighted that these cuts, initiated during Trump’s administration, have severely impacted the FDA’s institutional knowledge, which will take years to recover. They noted that this was part of an initiative led by Elon Musk, resulting in the loss of around 3,500 employees, creating a significant gap in expertise.
Robert Califf explained that the cuts under former commissioner Marty Makary were disastrous, causing the departure of many key talents. Ned Sharpless pointed out that the companies he works with are now struggling with a lack of expertise, as they find themselves dealing with less experienced reviewers in the fields of drugs and medical devices.
Scott Gottlieb emphasized that the agency has lost much of its institutional memory, posing a major challenge to restoring regulatory efficiency and effectiveness.
Hopes for Rebuilding
Despite these challenges, the former commissioners remain optimistic about the agency’s future. They stressed the importance of new leadership focused on rebuilding trust and restructuring. Gottlieb mentioned Kyle Diamantas, the current Food Commissioner, and Grace Graham, the agency’s policy leader, as key figures driving the FDA back to its core mission.
They explained that the FDA needs to concentrate on its primary role of ensuring the safety and effectiveness of drugs, steering clear of political issues.
The Need to Restore Trust
The commissioners also addressed the issue of rebuilding trust in federal agencies after the COVID-19 pandemic. Sharpless highlighted the communication mistakes made regarding vaccines during the pandemic. Califf and Gottlieb criticized the policies of current Health Secretary Robert F. Kennedy Jr., which they believe have harmed public trust.
Califf noted that the trust issue goes beyond individual policies, reflecting public frustration with high healthcare costs. He emphasized that the FDA should focus on its core regulatory role without getting involved in matters like drug pricing or vaccine hesitancy.
Conclusion
Amid the challenges facing the FDA, there is an urgent need to rebuild trust and recover lost expertise. New leadership offers a chance to guide the agency toward a more stable future, focusing on its essential roles without veering into political issues. Restoring trust in federal agencies requires a collective effort and support for the workforce to ensure rational and effective regulatory decisions.