Washington is heading into a period of turnover, and federal health agencies will need to strengthen their workforce and regulatory approaches to keep pace with fast-moving innovation, former FDA Commissioner Scott Gottlieb, MD, said Tuesday during ASTRO’s second Keynote of the Annual Meeting.
In a conversation moderated by James Metz, MD, of the University of Pennsylvania, Dr. Gottlieb drew on his experience as the 23rd Commissioner of the U.S. Food and Drug Administration and his current work as a senior fellow at the American Enterprise Institute for Public Policy Research and partner at New Enterprise Associates to offer his view of the health care horizon.
Dr. Gottlieb said he expects additional turnover at federal health agencies in the coming year, adding to recent departures of experienced clinicians and managers at the FDA. Rebuilding that expertise, he said, will require sustained attention to recruiting senior staff and strengthening the agency’s day-to-day operations.
His advice to incoming regulatory leaders was to focus less on headline-making policy and more on the fundamental work of running an effective agency. At the FDA, he said, that includes restoring experienced leadership while modernizing regulatory processes to address rapidly evolving technologies.
Much of the discussion centered on artificial intelligence. Dr. Gottlieb recalled developing an AI regulatory framework during his tenure at the FDA, but said the technology at the time looked very different from today’s large language models and continuously evolving systems. “We never envisioned an LLM,” he said.
That evolution raises new questions about whether traditional, one-time regulatory approvals are appropriate for technologies that may change frequently after entering clinical use. Dr. Gottlieb pointed to the FDA’s approach to digital health products as one possible model, with greater emphasis on the quality of a company’s validation processes rather than reviewing every iteration of an individual tool.
He also distinguished between AI used in drug development and AI incorporated directly into clinical practice. The former may change how a therapy is discovered and understood without fundamentally altering how the FDA evaluates the resulting product, he said. Clinical AI presents different regulatory questions, particularly when software begins to influence clinical decisions.
Across those uses, Dr. Gottlieb said standards for validation, safety and transparency could provide guardrails without requiring government approval of every AI application.
The conversation also turned to challenges closer to radiation oncology, including shortages of cancer drugs and radiopharmaceuticals. Dr. Gottlieb pointed to limited manufacturing capacity, aging facilities and narrow margins as factors that can make supplies vulnerable. Sustainable reimbursement, he said, is one part of maintaining a reliable supply chain.
Asked how radiation oncology can navigate the tension between technological innovation, reimbursement and access, Dr. Gottlieb encouraged the field to keep patient access at the center of its policy arguments.
He highlighted the effects of payment pressures on rural and underserved communities, where the loss of local care can force patients to travel significant distances to larger centers. For ASTRO and other organizations seeking changes in reimbursement policy, he advised developing legislative proposals, building support over time and documenting how policies affect patients’ ability to receive care close to home.
“These legislative ideas take a long time to enact,” Dr. Gottlieb said, but keeping well-developed proposals in front of policymakers can eventually lead to action.
Despite the challenges facing regulators and health care systems, Dr. Gottlieb closed on an optimistic note. Advances in AI and medical technology, he said, make this a moment of “tremendous opportunity” for medicine, provided that policy and regulation can evolve alongside them.
