With the new administration of President Donald Trump and the GOP's control of Congress, the stage is set for seismic shifts in the nation's regulatory agencies. That includes the Food and Drug Administration (FDA), which oversees products responsible for approximately 25 cents of every consumer dollar, encompassing drugs, biologics, medical devices and food. With new leadership appointments and political priorities in play, the trajectory of FDA regulation could veer sharply in the coming months and years.
A hallmark of any new administration is the appointment of key leaders, and Trump's nominations for the FDA commissioner and secretary of Health and Human Services are poised to influence the agency profoundly. However, Secretary of Health and Human Services Robert F. Kennedy Jr. and nominee for FDA Commissioner Dr. Marty Makary have raised concerns within the public health and scientific communities.
Kennedy, a notorious anti-vaccine activist and conspiracy theorist, could disrupt FDA approvals, wielding his ultimate authority over agency decisions. An obscure fact is that the ultimate authority for all the FDA approvals — drugs, biologics, medical devices, food additives, and so on — technically resides with the secretary of Health and Human Services, who then routinely delegates individual decisions to the FDA commissioner. (He or she may, in turn, delegate approval authority farther down the food chain.)
Thus, Kennedy's potential to override scientific consensus in favor of dangerous personal ideology could jeopardize public health initiatives and sow uncertainty, if not panic, across regulated industries. And Makary's pandemic-era positions on masking and natural immunity have likewise sparked criticism and concern from the scientific and public health communities. His confirmation could trigger an exodus of veteran FDA employees, further destabilizing the agency's operations.
Adding to these challenges is an executive order mandating that federal employees return to in-office work, a move likely to prompt resignations among staff who relocated during the pandemic. The "deferred resignation program" that would put federal employees on paid administrative leave through September, after which their employment would be terminated, has likely had the same effect, although numbers have not been released. With fewer reviewers, inspectors and administrators, approval timelines for drugs, devices and other products could lengthen — a worrisome development.
In recent years, the FDA has prioritized innovation, including pathways for approving over-the-counter drugs. These initiatives reflect a broader commitment to modernizing drug production, but their future hinges on the new administration's policy priorities.
Artificial intelligence and digital health also remain at the forefront of the FDA's agenda. Draft guidance on AI's role in regulatory decision-making for drugs and biologics has already been released in 2025. While AI promises to transform medical product development, regulatory frameworks must evolve to address its unique challenges. How the Trump administration balances innovation with oversight will be closely watched.
The 2024 Supreme Court Loper Bright decision overturned the "Chevron doctrine," which had granted federal agencies significant deference in interpreting their regulatory authority. Now, courts with limited expertise will likely review many complex FDA decisions, potentially leading to fragmented rulings and inconsistent enforcement. (We have seen that already in a scientifically flawed decision concerning USDA's regulation of genetically engineered plants.) The fallout from Loper Bright could fundamentally reshape how the FDA develops and implements regulations.
Adding to the complexity of FDA's oversight, last year the agency issued guidance to combat misinformation about medical devices and prescription drugs. Accurate information is vital for public health, but how the incoming leadership approaches this issue will signal its broader communication strategy. Unfortunately, both Kennedy and Makary have been notorious for spreading medical misinformation. Their track records raise questions about FDA's ability to uphold its commitment to science-based communication.
Although the Trump administration's deregulatory bent may streamline certain processes, it also risks introducing instability. The interplay among political leadership, regulatory priorities and industry innovation will define the FDA's trajectory. Collaboration among stakeholders — regulators, industry leaders and public interest and patient groups — will be crucial to ensuring that regulatory frameworks protect public health while fostering innovation. The stakes are high.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He was the founding director of the FDA's Office of Biotechnology.