Opinion: Former FDA commissioners: Heidi Overton has an opportunity to strengthen the FDA

Sept. 22, 2026 Gottlieb was the FDA commissioner from 2017-2019 and currently is a senior fellow at the American Enterprise Institute and a partner at New Enterprise Associates. McClellan was the FDA commissioner from 2002-2004 and is the founding director of the Robert J. Margolis, M.D., Institute for Health Policy at Duke University. Heidi Overton has been nominated to lead the Food and Drug Administration at a moment of significant opportunity, but also big challenges. Innovation in medicine has never moved faster, providing more ways for Americans to improve their health and for the United States to advance the health of its population. But the institutions that carry that progress forward are under strain. Overton has a chance to help bridge that divide — and the experience to do it. She has the opportunity to demonstrate these goals at Thursday’s confirmation hearing in front of the Senate health committee. One key area is life-changing biomedical innovation. Other parts of the world are advancing their own biomedical enterprises quickly. With consistent support to build both regulatory expertise and clinical development capacity, China is now delivering more of the innovations that once reached patients first in America. More Phase 1 trials now start in China than in the U.S. It’s a reflection of real scientific progress underway in China, but also the country’s ability to move new compounds into Phase 1 trials more quickly than the U.S. can. Similar shifts are also underway for later stage clinical trials and the path to earlier approval, coverage, and access. The science in front of us couldn’t be more promising, and it all runs through the FDA. Gene therapies are being crafted for individual patients, and cell therapies once used to treat cancer are being repurposed for autoimmune diseases. Artificial intelligence can bring dramatic new efficiencies to the FDA and to routine medical practice. Vaccines will soon reach new diseases. Overton has a long track record of thinking carefully about practical policy changes and the mechanics of implementing reforms, including her notable work in the initial Covid-19 response. She also benefits from close relationships with White House leadership, which will help her move FDA policy through interagency processes and address challenges with urgency. Both of us benefited from that same alignment during our time at FDA, which facilitated multi-agency reform initiatives on major policy priorities, like PEPFAR and the opioid crisis. Some decisions at the FDA since her nomination also align with our belief that she could bring similar benefits back to the agency. The lasting impact of any commissioner is fundamentally about the strategic implementation of policy. The commissioner and a few political advisers can’t review applications on their own, and should not be involved in those matters; it takes thousands of career physicians and scientists do that. The commissioner’s job is to help decide which big priorities the agency will take on, then support the professional staff’s hard work to turn those priorities into predictable, sound scientific guidance and regulations, along with supporting review innovations that can be reliably applied to new products. With the reductions in FDA staffing and past disconnects between appointed leaders and career staff, ideas for everything from modernizing clinical trials to changing the regulation of testosterone have withered somewhere between the speech or television hit announcing them and any practical, reliable policy change that would see them implemented. The ability to drive these reforms and improve the FDA’s review functions turns on the efforts of its product centers. A commissioner owes them clear priorities, an achievable set of well-defined policy goals, and sufficient qualified staff to do the work. This reality applies not just to biomedical innovation, but to other critical FDA responsibilities, from addressing the preventable deaths from combustible tobacco to advancing new innovations to creating a clear process for supporting Americans in healthier food choices. FDA’s current acting commissioner, Kyle Diamantas, has taken steps to strengthen the workforce. Overton will be able to build on that and rebuild an agency that has suffered substantial losses in personnel and morale. The FDA lost about 3,500 employees in the April 2025 layoffs, and more in the voluntary departures that followed. The reductions eliminated entire offices that drafted policy and regulations and hit the project managers who keep reviews on schedule and the teams that support inspectors. This has started to change, with many new job postings announced to build back professional staff capabilities. But a permanent commissioner provides the certainty and reliability FDA leadership needs to turn this shift into a true inflection point for the agency. The most impactful thing a new commissioner can do for morale is to demonstrate to the review teams that their views and critical role in the regulatory process will be respected and considered. Speed and steadiness aren’t in tension at the FDA. The agency’s work moves efficiently when review staff knows leadership will stand behind them and help them take on regulatory challenges to ensure the safety and efficacy of the products they review. We believe Overton sees the job this way. This month, the current FDA leadership made permanent the experienced career officials who had been running the drug, biologics, and tobacco centers on an acting basis. Two of the newly appointed officials are agency veterans. After a stretch in which the drug and biologics centers cycled through a string of political leaders that caused unnecessary disruptions, these were choices for continuity and continued progress. We believe these moves are consistent with Overton’s goals. They are the actions of leaders who intend to lean on the FDA’s own expertise and have confidence in the agency’s workforce. Agency officials who have worked with Overton have also told us she often backed them on difficult calls. This week’s hearing is an early test, and an opening. It gives Overton a chance to show her commitment to the principles behind the FDA’s public health mission. She should use it to stake out her own independent thinking on the important issues the agency will face. These include the agency’s goal of advancing new innovations to address rare diseases, the role of vaccines in protecting public health, and support for further policy changes that will return the FDA’s vaccine regulation to more predictable, science-driven processes. The agency’s scientists, the patients they serve, and those who develop new advances here and across the world will be listening closely. The FDA needs a leader who can turn important health challenges into policy initiatives that the agency can develop and carry out, and who trusts and supports the people implementing them. Overton has hard work to do but has demonstrated the capacity to be that leader. She knows the challenges she’ll face and what it will take to secure the promise of better public health. Scott Gottlieb was the FDA commissioner from 2017-2019 and currently is a senior fellow at the American Enterprise Institute and a partner at New Enterprise Associates. He serves on the boards of United Healthcare and Pfizer. Mark McClellan was the FDA commissioner from 2002-2004 and is the founding director of the Robert J. Margolis, M.D., Institute for Health Policy at Duke University. He serves on the boards of Cigna and Johnson & Johnson.