Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institute’s Annual Conference, continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own.

Now firmly in the chair after the agency’s controversial RIFs—which he was quick to remind everyone he did not initiate—Commissioner Makary said that the FDA’s future depends on rebuilding its culture, empowering its staff, and applying his vision of the now oft-repeated “gold standard science and common sense.” The agency, he noted, isn’t a passive inbox for industry petitions. It’s a brand—the greatest in the world, he said—and he thinks that change is needed to live up to that lofty reputation.

Many of the Commissioner’s comments were familiar to those who have followed his podcasts and book rounds: he firmly believes the FDA’s regulatory model needs disruption. Dr. Makary noted that he doesn’t believe that the traditional playbook works for everything—particularly in the case of life-threatening diseases where randomized controlled trials are neither feasible nor humane. “Stage IV cancer should not be approved like a cosmetic,” he quipped, quickly calling to mind his days as an oncological surgeon and the many difficult conversations he had with patients and families with very limited options. Industry can, however, expect smarter tailoring of regulatory frameworks by condition, product type, and risk. He also specifically mentioned rare diseases here, in addition to his example of late-stage illnesses.

While Commissioner Makary reiterated the “no reorganization” refrain that has been consistent since he took the helm, he is interested in reducing internal redundancies and called for more consolidated operations and smarter tech.  He spoke with obvious enthusiasm about the recently announced pilot AI-assisted review and its potential to shave weeks off approval timelines, as he described hearing from one reviewer in the pilot project who said the pilot AI tool completed three days’ work in gleaning salient facts from medical literature in six minutes.

Beyond regulatory work, the Commissioner ventured into what he called “crossing into advocacy,” especially relating to food regulation. Citing the chronic health crisis among children, he challenged attendees to rethink society’s tolerance for environmental and dietary toxins, from petroleum-based food dyes to candy coated in talc. “Kids don’t have a willpower problem,” he said. “We’ve been poisoning them and drugging them at scale.” Expect new expert panels starting in June on infant formula, menopause, and peanut allergies, and a renewed focus on the upstream causes of America’s downstream health costs.

He delivered sharp words on tobacco and e-cigarette imports, warning that foreign manufacturers are gaming our “porous border” by importing products that would be illegal in their own countries. He also promised a clearer vaccine framework from CBER perhaps in a matter of days, a stronger commitment to “the letter and the spirit of Right to Try,” and major investment in post-market safety surveillance via big data.

Commissioner Makary made it clear that he isn’t here to maintain the status quo and he is here to shake loose entrenched assumptions, and remind industry of his view that common sense, in the right hands, can be a regulatory force multiplier. How he will impose common sense on policy will unfold over the next few months.  We’ll be back with updates.