There has been much speculation about what is in store for the Food and Drug Administration in the incoming administration, as President Trump and his likely nominees for senior health positions — including Robert F. Kennedy Jr. for secretary of Health and Human Services and Marty Makary for FDA commissioner — have expressed strong views about how the FDA regulates our nation’s foods, drugs/devices, and cosmetics. RFK Jr. has called for a major shakeup at FDA.
Every new administration brings in senior officials who want to put their own imprimatur on their agencies. We expect the new appointees will seek to do the same at the FDA. We will find out more about their plans at the confirmation hearings for Kennedy and Makary and as new senior officials are appointed. Change at the FDA is a constant as the agency evolves to address new products and challenges. We welcome thoughtful change intended to better position the FDA to meet today’s and future challenges.
But as they and the rest of the incoming team develop plans, we hope that they keep in mind certain key features of the agency that define it. These principles have created what is universally regarded as the leading science-based consumer protection agency in the world.
We have all served in senior positions at the FDA, and we believe we speak for current and former FDA employees in advocating for maintaining the defining features that make the FDA uniquely capable of and respected for protecting Americans from unsafe products.
Chief among these features are three key characteristics:
- A work environment that attracts and keeps the best experts available to set standards, evaluate new products, and set priorities for enforcement. To regulate the types of medical products now being developed, such as cell and gene therapies, or to understand how to use artificial intelligence to develop new products, requires a high level of education and training. The FDA has been able to attract this high level of talent because its leaders have expressed confidence in and rely on their expertise and have created a conducive work environment.
- A reliance on good science to make regulatory decisions. The FDA defines itself as having two key pillars: science and law. The laws are written by Congress. The science comes from careful evaluation of well-conducted and validated scientific studies. The FDA itself conducts few such studies. They are generally sponsored by agencies such as the National Institutes of Health or by regulated industry. They are conducted by universities or research companies that specialize in studies. FDA scientists are educated and trained to evaluate such studies and make decisions consistent with the laws. A commitment to good science provides the underlying support for FDA scientists to make decisions based on sound data.
- Careful science-based decision-making that is internationally recognized as the gold standard. The FDA plays a central role in keeping America competitive in an increasingly complex environment. American companies lead the world in developing innovative new medical products and in using technology to advance research and to monitor the safety of products including our food supply.
The incoming team will serve the public best by recognizing these features and by committing to maintaining a sound work environment, a reliance on good science as the basis for decisions, and an international competitiveness based on the FDA’s credibility.
There are lessons to be learned from the first Trump administration. The overwhelming national challenge in the last year of that administration was to develop a Covid vaccine. FDA staff understood the urgency and worked tirelessly with Operation Warp Speed to achieve what many regarded as unachievable — develop, test, and approve two safe and effective vaccines in less than a year. As that experience demonstrates, if harnessed productively, FDA staff will invariably apply their expertise and energy collaboratively to achieve the needed public health outcome.
The incoming administration should view FDA staff not as enemies, but as an extraordinarily valuable resource to pursue partnerships to advance public health. The second Trump administration also needs to ensure that the FDA is well-funded. Its funding model is complex. Much of the agency, including the entire tobacco center and much of the drug and device centers, is funded from fees paid by regulated companies. Only about half of the overall budget comes from congressional appropriations.
While the funding model is not necessarily ideal, if user fees were eliminated, securing adequate funding from Congress might be problematic. The FDA needs leadership that will advocate for ongoing increases in funding sources. Food programs, which do not have user fees, are especially underfunded.
The incoming leaders will face many challenges: the adoption by the FDA of AI and the regulation of products that use AI; the challenge of drug shortages; the inevitable transition to new approaches to drug and device testing; the development of lifesaving cell and gene therapies. These challenges and many more are driven by advances in science and technology and by economic factors, and they need to be addressed to assure that consumers can confidently use the products regulated by the FDA.
The incoming leaders will find that the FDA staff are remarkably talented and intensely dedicated to public health. They know that science and technology are changing our world, and that regulation and oversight need to keep pace. They understand, for example, the huge potential health benefits of an expanded focus on nutrition. They will welcome change that will help them further the long-standing mission of the FDA, to protect and advance the public health.
Stuart Pape, J.D., was associate chief counsel for foods at the FDA. Wayne Pines was associate commissioner for public affairs for the FDA. Mitch Zeller, J.D., was director of the FDA Center for Tobacco Products. The views expressed here are solely those of the authors.