Following his tenure as FDA Commissioner, Dr. Marty Makary brings a firsthand perspective on artificial intelligence, medical innovation and the challenges shaping the future of American healthcare.
A New Chapter in the Future of Healthcare
When Dr. Marty Makary addressed the American College of Surgeons Clinical Congress on September 28, 2026, he had a message that extended well beyond the latest medical breakthroughs. The former Commissioner of the U.S. Food and Drug Administration argued that improving American healthcare requires confronting longstanding problems that technology alone cannot solve.
Speaking before an audience of medical professionals, Makary identified four persistent challenges: administrative waste, failures in healthcare pricing, low-value medical care and insufficient attention to the underlying causes of disease. His presentation reflected a perspective developed over decades as a surgeon, researcher and advocate for greater transparency in medicine, now informed by his recent experience leading one of the nation’s most influential regulatory agencies.
For healthcare executives, hospital administrators and medical innovators, the timing is significant. Artificial intelligence is changing how scientific information is analyzed, new treatments are emerging and regulators are experimenting with faster approaches to reviewing medical products. Yet questions about cost, access, quality and patient trust remain unresolved. Makary’s central challenge to the healthcare industry is therefore not simply how to innovate faster, but how to ensure that innovation addresses the problems that matter most.
Bringing Artificial Intelligence Into the FDA
During his tenure as the FDA’s 27th commissioner, from April 2025 to May 2026, Makary made artificial intelligence a visible part of the agency’s modernization agenda. In June 2025, the FDA launched Elsa, a generative AI assistant intended to help employees work with scientific and regulatory information more efficiently. Potential applications included summarizing documents, supporting scientific reviews and helping staff navigate large collections of information. The agency followed in December with an announcement expanding access to agentic AI capabilities, which can assist with more complex, multistep workflows under human oversight.
For an organization responsible for evaluating medicines, medical devices and other regulated products, the appeal is clear. Scientific reviewers must assess extensive evidence, identify potential safety concerns and document decisions that can have enormous consequences for patients and manufacturers. AI may help reduce repetitive work and improve access to relevant information. But introducing an AI system is not the same as demonstrating that it consistently improves regulatory decisions.
Early accounts from FDA employees included both positive experiences and concerns about inaccurate AI-generated responses. The agency’s announcements described capabilities and expected efficiencies, while broader evidence of long-term performance remained limited. That distinction matters far beyond government regulation. Hospitals, pharmaceutical companies and other healthcare organizations face similar questions as they adopt AI: Which tasks can technology support effectively? Where is expert judgment indispensable? And how should institutions measure whether a new tool actually improves their work? Makary’s FDA experience offers a timely case study in the opportunities and responsibilities that accompany organizational transformation.
Can Medical Innovation Reach Patients Faster?
Another major priority during Makary’s leadership was reducing avoidable delays in the development and regulatory review of medical treatments. In June 2025, the FDA announced the Commissioner’s National Priority Voucher pilot program, designed to accelerate reviews of selected drug applications addressing important national health priorities. Rather than following conventional review schedules, qualifying applications could receive enhanced communication with regulators, rolling review and a more coordinated evaluation process.
The program subsequently produced several unusually rapid decisions. In February 2026, the FDA approved an expanded indication for the lung cancer treatment Hernexeos following a review lasting 44 days from filing. In April, it approved the oral weight-management medicine Foundayo 50 days after filing. These were documented examples of expedited regulatory action, not evidence that every FDA application could or should be reviewed on the same schedule. The distinction is important because speed and scientific rigor must operate together. Patients awaiting effective treatments may benefit when unnecessary administrative delays are eliminated, but drug approval still requires careful evaluation of safety, effectiveness and the quality of submitted evidence. The pilot also attracted scrutiny from regulatory experts and industry observers concerned about whether compressed timelines could place pressure on scientific reviewers. The FDA maintained that participating applications remained subject to established approval standards.
Beyond drug reviews, Makary’s tenure included efforts to modernize the scientific methods used in drug development. An April 2025 FDA roadmap encouraged alternatives to certain animal studies, including computational modeling and human-derived laboratory systems where appropriate. The agency reported implementation progress in April 2026, although broader effects on development costs, timelines and patient outcomes require continued evaluation. Together, these initiatives illustrate a larger question confronting medicine: How can institutions remove inefficiencies without weakening the safeguards that make innovation trustworthy?
The Problems Technology Alone Cannot Solve
At the American College of Surgeons meeting, Makary returned to concerns that have shaped much of his career. His first challenge, administrative waste, focused on the complexity of healthcare financing and the many intermediaries involved in payment and reimbursement. Modern healthcare organizations operate within intricate networks of insurers, employers, pharmacy benefit managers and administrative contractors. While these arrangements serve different purposes, Makary argues that their complexity can divert resources and attention away from direct patient care.
His second concern was pricing transparency. Patients often struggle to determine what medical services will cost before receiving treatment, making it difficult to compare options or anticipate financial obligations. Makary has long advocated for clearer pricing information and greater accountability in healthcare billing.
The third issue, low-value medical care, concerns treatments and procedures that may offer limited benefit in particular circumstances. Makary discussed variations in surgical practice and the importance of examining outcomes and treatment patterns. His broader point was that better information can help clinicians recognize unnecessary variation and make more informed decisions.
Finally, he challenged medical professionals to investigate underlying causes of disease rather than relying unquestioningly on established assumptions. Scientific knowledge evolves, and medical recommendations sometimes change as stronger evidence becomes available. For Makary, that reality underscores the importance of intellectual openness and continued research.
These arguments are not a rejection of technology. They are a reminder that advanced systems can make existing processes faster without necessarily making those processes better. A hospital might adopt sophisticated software while patients still struggle to understand their bills. A pharmaceutical company might accelerate aspects of development while access to treatment remains difficult. An organization might invest in AI without reconsidering whether its underlying procedures serve patients effectively. For healthcare leaders, the lesson is to evaluate innovation not only by technical sophistication, but by its contribution to quality, affordability, transparency and patient care.
From the Operating Room to National Healthcare Policy
Makary’s perspective is rooted in a career that began long before his appointment to the FDA. A surgical oncologist and longtime Johns Hopkins professor, he has conducted research on patient safety, surgical outcomes, healthcare costs and unnecessary medical care. His work has included contributions to surgical safety practices and efforts to improve transparency in healthcare delivery.
He was elected to the National Academy of Medicine in 2018, recognition of his contributions to medical research and healthcare improvement. His books have also brought complex healthcare issues to a broader audience. In The Price We Pay, Makary examined the financial structures and practices contributing to America’s healthcare costs. In Blind Spots, he explored how established medical beliefs can persist even when emerging evidence suggests a need for reconsideration. These themes became especially relevant during his FDA service, when questions about scientific evidence, regulatory efficiency and institutional accountability moved from research and commentary into the daily responsibilities of federal leadership.
His tenure was also marked by controversy, including debates over expedited reviews, agency staffing and regulatory oversight. Those disagreements are part of the record and illustrate the difficulty of pursuing change within institutions where decisions carry substantial public consequences. Now, as a former commissioner addressing professional audiences, Makary can draw on experience from clinical medicine, academic research, public communication and federal regulation.
What Healthcare Leaders Can Learn From a Changing System
The significance of Makary’s experience extends beyond the FDA. Healthcare executives are navigating a period in which technological possibilities are advancing rapidly while financial pressures, workforce demands and expectations for better patient outcomes remain intense. Pharmaceutical and biotechnology organizations face difficult decisions about research investment, evidence generation and regulatory strategy. Medical associations must help professionals interpret new technologies without losing sight of clinical judgment. Makary’s work highlights several leadership questions that apply across these settings. Organizations must determine which innovations solve meaningful problems, how to challenge entrenched assumptions constructively and what evidence should be required before declaring an initiative successful.
Transparency is equally important. Whether discussing treatment outcomes, healthcare prices or the limitations of AI, leaders build credibility when they communicate clearly about what is known, what remains uncertain and how decisions are made. Perhaps the most enduring lesson is that responsible innovation requires both ambition and accountability. Progress depends on the willingness to question established practices, but lasting improvement also depends on careful measurement, scientific rigor and trust. For conference audiences, these tensions make the future of healthcare a particularly compelling subject. The conversation is no longer limited to which technologies will emerge next. It also concerns how institutions can use those technologies wisely.
Book Dr. Marty Makary for Your Next Healthcare Conference
As healthcare organizations navigate artificial intelligence, medical innovation, changing regulations and growing expectations for better outcomes, Dr. Marty Makary offers a perspective informed by clinical practice, academic research, bestselling books and leadership at the highest level of federal healthcare regulation. His experience makes him a compelling keynote speaker for healthcare conferences, medical associations, pharmaceutical and biotechnology organizations, hospital leadership meetings and corporate events examining innovation, transparency and the future of medicine. To inquire about Dr. Makary’s speaking fee, availability and keynote presentations for your next event, contact Speakers.com.
