The Food and Drug Administration (FDA) and other key public health agencies are undergoing major leadership and structural changes following recent moves by the Trump administration and Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.
The shake-up includes mass layoffs, agency leadership resignations, and public disputes over federal drug approval policies and vaccine regulation.
Earlier this week, HHS confirmed a reduction of 20,000 positions, accounting for approximately 24% of its workforce. As part of the restructuring, the National Institutes of Health (NIH) reportedly placed five agency chiefs on administrative leave Monday.
Among those affected are leaders from the National Institute of Allergy and Infectious Diseases and the National Institute of Child Health and Human Development.
These divisions have come under scrutiny for past research funding decisions, including grants related to Chinese labs and controversial gender research.
New NIH Director Jay Bhattacharya, who was sworn in on Tuesday, informed staff in an internal email that the reorganization would require changes to the agency’s approach in areas such as communications, legislative affairs, procurement, and human resources.
He emphasized priorities like scientific transparency and academic freedom. NIH’s Deputy Director of Public Affairs, Amanda Fine, directed media outlets to file Freedom of Information Act requests to access the email, calling it an “official record.”
Nature reported that some of the NIH and Centers for Disease Control and Prevention (CDC) staff were offered reassignment to the Indian Health Service.
NOTUS also confirmed that CDC officials had received similar transfer offers, particularly relocating away from the agency’s main office in Atlanta.
At the FDA, significant changes have drawn attention from the pharmaceutical industry.
Former FDA Commissioner Robert Califf, who served in the Obama and Biden administrations and later worked in a strategic role for Google’s parent company Alphabet, wrote on LinkedIn that the agency “as we’ve known it is finished.”
He warned that a loss of experienced leadership could affect drug development and public safety.
Califf’s departure follows that of other top officials. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), resigned last week.
Politico and the Associated Press reported that Marks was given the option to resign or be dismissed by Secretary Kennedy, with the approval of newly installed FDA Commissioner Marty Makary.
Marks’ March 28 resignation letter, addressed to acting Commissioner Sara Brenner, cited concerns about misinformation but did not mention the ultimatum.
Makary, whose swearing-in date was not specified in the FDA’s April 1 press release, has already made staffing changes.
On Wednesday, Danish-American vaccine safety researcher Tracy Beth Hoeg confirmed she was hired as a special assistant to Makary. Hoeg has publicly criticized federal COVID-19 research and vaccine policies, including the U.S. childhood immunization schedule.
Marks’ departure coincided with a sharp decline in the stock prices of several biotech firms. Companies like Moderna, Beam Therapeutics, and Sarepta Therapeutics saw significant single-day losses, according to the Wall Street Journal.
These companies are heavily invested in mRNA and gene therapy technologies, areas that Marks previously supported.
University of California San Francisco epidemiologist Vinay Prasad criticized Marks’ leadership, citing repeated approval of COVID-19 boosters for infants without randomized clinical trial data.
Stanford professor George Tidmarsh echoed those concerns, accusing Marks of prioritizing pharmaceutical industry interests over patient safety.
Both cited controversial FDA decisions, including the approval of aducanumab, an Alzheimer’s drug that has since been withdrawn. Critics argue it was authorized without adequate evidence and based on disputed scientific theories.
Bhattacharya raised similar concerns about NIH’s approach to Alzheimer’s research during his Senate confirmation hearing.
The broader restructuring of public health agencies comes amid increased scrutiny of federal science policy, pharmaceutical regulation, and administrative spending.
The administration has also moved to reduce indirect-cost payments on federal research grants, a policy that critics say disproportionately benefits institutional administrators over researchers.
The White House has not yet provided an official timeline for the full implementation of the staffing changes. Additional reassignments, restructuring, and appointments are expected in the coming weeks.
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