In late March, a wave of changes at HHS and the FDA marked the beginning of what may be a defining moment for the U.S. regulatory landscape. With staffing reductions affecting thousands, remaining FDA employees, industry professionals, and the general public alike are watching closely to understand how these shifts may influence regulatory timelines, policy coordination, and future oversight of medical products.
Change began in late March, when HHS Secretary Robert F. Kennedy Jr. announced a major downsizing initiative, amounting to a reduction of around 10,000 jobs across HHS. The FDA lost 3,500 employees, roughly 19% of the agency’s workforce, mostly from administrative and policy roles. While clinical reviewers and inspectors have been largely secure to this point, critical policy and operational personnel, especially within CDER and CBER, were among those affected. Some entire units, like the travel office that supports inspections, were eliminated.
Most troubling to many in the research community is the targeting of post-market surveillance systems and data access protocols. The resignation of CBER Director Peter Marks, announced March 31 and effective April 5, also made headlines soon after.
Additionally, a reorganization plan that would consolidate FDA’s 19 centers into five cross-functional offices was proposed, though newly confirmed FDA Commissioner Marty Makary was quick to reject it. “We are not reorganizing,” Makary said in a MedPage interview, reaffirming that CDER, CBER, and other product centers will continue operating under the administration’s current model. Instead, Makary stated that his focus will be on streamlining administrative functions, preserving scientific capacity, and launching new initiatives, including AI-supported reviews and conditional approvals using real-world data.
Industry groups, including PhRMA, BIO, among other organizations and patient groups, have voiced concern regarding the long-term impact of such changes, warning that a weakened FDA could delay life-saving therapies, reduce investor confidence in U.S. biopharma innovation, and even drive R&D and clinical trials overseas. In early April, a coalition of over 200 biotech leaders, investors, and patient advocates sent a letter to Senate HELP Committee Chairman Bill Cassidy focused on preserving and modernizing the FDA, citing risks to innovation and patient safety. ACRO also submitted a statement for the record to the Senate Appropriations Committee regarding the May 9 hearing “Biomedical Research: Keeping America’s Edge in Innovation.” With the FY 2026 budget proposal calling for steep cuts to the FDA, NIH, and CDC, such concerns remain front and center.
Bottom line: the FDA is navigating a period of extreme change, with implications for regulatory timelines, innovation investment, and global perception. Whether the agency can maintain its scientific integrity and operational capacity under such rapid changes remains an open and urgent question.