Former FDA commissioner Robert Califf expressed his concern on social media about the recent mass layoffs at the FDA, stating that the agency is undergoing significant changes. The layoffs included the removal of senior and mid-level leaders, as well as a large number of staff members. The White House had announced that the FDA alone would experience around 3,500 job cuts, with nearly 20,000 job cuts expected across various agencies.
Califf highlighted the impact of the restructuring on the agency's relationship with the industry, noting that the departures of many leaders and staff members have disrupted stability. He emphasized the need to rebuild the agency, which could lead to unpredictability, a concern for the industry.
Former commissioner Scott Gottlieb, who served during Trump's administration, also expressed frustration over the situation on social media. He emphasized the importance of reforms to boost drug research in the US and avoid falling behind Europe.
Califf emphasized the need to focus on the future and create a new FDA that can effectively carry out its responsibilities. He raised concerns about the lack of transparency in the current changes and referenced Project 2025, a document that suggests a potential roadmap for the administration.
The layoffs at the FDA have caused uncertainty and alarm in the pharmaceutical and biotech industries, adding to the challenges faced by the agency.