The next Commissioner of the Food and Drug Administration does not need to be a physician. But he does need to be a diagnostician.
The FDA's biggest challenges today are not clinical. They are organizational. The agency must restore confidence in its decisions, attract and retain the best scientific talent, keep pace with innovations that are transforming medicine, and ensure that patients have timely access to safe and effective therapies. Those are leadership challenges and that's why Jim O'Neill would make an outstanding FDA Commissioner.
Having served at the FDA as an Associate Commissioner, I learned a simple lesson: successful leaders understand the agency's mission, respect the people who carry it out, and know how to move the organization forward. Few people understand all three better than Jim O'Neill.
The FDA exists for one reason: to protect and promote the public health. That sounds obvious, but it is surprisingly easy to lose sight of that mission amid congressional hearings, political pressures, media scrutiny, and the endless demands of Washington. Every FDA commissioner faces those pressures. The successful ones never allow them to distract from the agency's core purpose. O'Neill gets that.
He also understands something equally important. Confidence in the FDA will not be rebuilt through headlines, slogans, or political theater. It will be rebuilt through performance.
Too often, Washington confuses disruption with leadership. It celebrates those who promise to tear institutions apart while paying less attention to those who know how to make them work better. Anyone who has spent time inside the FDA knows that meaningful reform doesn't happen through press releases or public relations campaigns. It comes from understanding where the problems are, separating symptoms from causes, and then doing the hard work of fixing them. That's what good diagnosticians do.
The FDA's greatest strength isn't its regulations, its laboratories, or its organizational charts.
It's its people. Every day, thousands of scientists, physicians, statisticians, reviewers, toxicologists, and public health professionals bring an extraordinary depth of expertise to their work. One of the biggest mistakes any incoming commissioner can make is assuming those professionals are the problem. The opposite is true. They are the foundation of the solution.
The most successful commissioners I observed during my years at the agency and since were not those who demanded loyalty. They were the ones who earned trust. The mistake outsiders often make about FDA is believing that leadership is about changing minds. It’s about channeling expertise.
The Commissioner signs the decisions, but FDA's credibility rests on the quality of the people who prepare them. My message to whoever becomes the next FDA Commissioner is simple: recognize that distinction. The good news is that Jim O'Neill already does.
He respects expertise and values informed debate. He listens carefully before reaching conclusions. He asks questions others might overlook. Most importantly, he understands that leadership is not about issuing directives from the front office. It's about creating an environment where talented people can do their best work.
Those who know O'Neill know he is exceptionally smart. But intelligence alone doesn't make someone an effective leader. Judgment does.
One of the qualities I admire most about O'Neill is that he is a consensus builder without becoming captive to consensus. He welcomes disagreement. He seeks out opposing viewpoints. But once the arguments have been heard and the facts are on the table, he makes decisions. That's an increasingly rare quality in government.
The next nominee should also be someone who can be confirmed by the Senate. Last year, Jim was easily confirmed as Deputy Secretary of Health and Human Services and President Trump recently nominated him to be Director of the National Science Foundation. He would be a great leader of NSF, but we need him more at FDA.
The FDA cannot afford paralysis. Scientific innovation is moving at extraordinary speed. Gene therapies, artificial intelligence, precision medicine, and other breakthroughs are reshaping healthcare in real time. The agency must evolve alongside that science while preserving the rigorous standards that have made it the world's most respected regulatory authority.
That requires a commissioner who can balance rigor with urgency and collegiality.
O'Neill understands something many reformers do not: good ideas are only the beginning. Success requires political judgment, coalition-building, persistence, and execution. He knows how government works. More importantly, he knows how to make government work.
Those who have worked with him often say he plans the work and works the plan. That may sound old-fashioned, but it reflects a discipline that is too often missing in public life.
Vision matters but execution matters more.
The FDA faces enormous opportunities and significant challenges. It must continue adapting to a rapidly changing scientific landscape while reinforcing the public trust that underpins every decision it makes.
That will require a leader who respects the institution without becoming captive to the status quo. A leader who values expertise without surrendering authority. A leader who understands that reform is a process, not a performance. In short, it will require a steady hand at the tiller.
The FDA doesn't need a media personality. It doesn't need a crusader. And it certainly doesn't need another round of performative disruption. It needs a diagnostician. Jim O'Neill is exactly that.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.
