COMMON-SENSE NOTES // By Idris B. OdunewuA Shining Star in a Contentious Legacy: Could Marty Makary Be the Saving Grace of a Divisive Presidency?
While much of the Trump administration has sparked controversy, the FDA’s consumer-first reforms may be remembered as its brightest legacy. From AI-driven drug reviews to bans on artificial dyes, the FDA’s agenda resonates with the public in ways few Trump-era policies have.
In a presidency defined by polarization, the FDA under Commissioner Marty Makary has emerged as an unlikely source of unity. Makary’s reforms—integrating AI into drug reviews, banning harmful food dyes, and clarifying processed vs. ultra-processed food labeling—have aligned with public concerns across the political spectrum. The pursuit of expedited drug reviews processes and the removal of controversial additives like Red Dye No. 3, are just a few initiatives supported by industry and the public alike. In contrast to the controversies surrounding immigration, taxes, and spending, the FDA’s direction could stand as Trump’s most constructive legacy: a tangible, people-centered effort to safeguard health and restore trust in government.
The FDA’s new trajectory under Makary contrasts with the administration’s many controversial policies and methods, carving out a distinctly different narrative—one that could, perhaps, stand as the administration’s saving grace. The many goals of Commissioner Makary’s initiatives align with public sentiment, positioning the FDA’s work to ultimately become the enduring bright spot in what many perceive to be an otherwise tumultuous presidency.
Marty Makary’s Mission: Modernizing the FDA’s Role
Dr. Marty Makary, a surgeon, public health advocate, and policy thinker, assumed the FDA Commissionership with a clear vision: modernize the drug approval process, embrace technology, and reorient the agency toward consumer safety and transparency. At a time when skepticism toward government institutions is on the rise, Makary’s approach reflects not only a technical agenda but also a cultural shift. His leadership has emphasized several priorities including:
1. Accelerating Drug Discovery and Approval: Makary has fast-tracked the integration of artificial intelligence into the FDA’s review pipeline, enabling faster and more accurate analysis of drug trial data. Traditionally, reviewing thousands of pages of clinical trial evidence required immense human labor and years of deliberation. With FDA’s new AI system—internally known as “Elsa”—the agency has begun automating repetitive tasks in submissions and pilot testing AI-assisted reviews. In May 2025, the FDA announced completion of its first AI-assisted scientific review pilot and committed to an agency-wide rollout later in the year. While still in its early stages, this initiative aims to reduce bottlenecks in the review process without sacrificing scientific rigor.
