Wind of Change: FDA Commissioner Makary Outlines His Vision for FDA

In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law Institute Annual Conference. His remarks outlined an ambitious framework for change, centered on cultural restoration, scientific integrity, regulatory flexibility, and selective modernization. Makary addressed a wide range of priorities, from internal staffing and enforcement shortcomings to the agency’s evolving approach to clinical evidence, food safety, and public health economics.

Highlights of the fireside chat included:

Rebuilding Culture Amid Organizational Streamlining

Makary began by addressing the impact of the recent reduction in force (“RIF”), which cut FDA staffing levels to where they stood in 2018-2019. He acknowledged the internal disruption caused by the RIF and made clear an intent to restore morale and empower scientific reviewers and inspectors, staff he called essential to FDA’s mission. Notably, he stated that those critical roles were spared from layoffs.

Makary also flagged inefficiencies across the broader Department of Health and Human Services, pointing to redundancies such as multiple Offices of Women’s Health across different components. He indicated a desire to streamline operations by consolidating certain support functions like IT and media and by reducing internal siloing that he viewed as obstacles to collaboration.

Refocusing Regulation on Context and Common Sense

Addressing drug approvals, Makary emphasized the need to apply “gold standard” science while recognizing that rigid frameworks, like randomized controlled trials, are not always practical or appropriate. For diseases such as late-stage cancers, rare genetic disorders, PTSD, and neurodegenerative conditions, he advocated for flexible standards that reflect the seriousness and urgency of clinical need. Rather than treating all therapeutic areas with a one-size-fits-all evidentiary threshold, Makary suggested that FDA must be pragmatic and consider alternative evidence models, particularly when the patient population is small or treatment options are limited.

Selective Modernization: AI, Clinical Trials, and Non-Animal Testing

Makary also focused on other areas of modernization, endorsing the selective use of new tools to improve efficiency. He cited a successful pilot showing that artificial intelligence can dramatically speed up data synthesis during scientific reviews, cutting the time required from days to minutes. He noted that this AI-supported review capability would be deployed agency-wide by June 30, 2025.

He also suggested that cloud-based, continuous clinical trials could reduce the time and cost of drug development, as well as a desire to minimize reliance on animal testing when validated alternatives, such as organ-on-a-chip technologies or real-world data, can serve similar functions. These tools, he argued, could contribute not only to increased scientific rigor but also to affordability by lowering development costs.

Food Policy and Pediatric Health

One of the more impassioned sections of the discussion focused on children’s health and the food system. Makary criticized current food safety standards as outdated and insufficiently protective, stating bluntly that the nation has been “poisoning kids and drugging them at scale.” He attributed the rise in chronic childhood diseases to additives and ingredients common in ultra-processed foods.

He previewed aggressive policy moves, including a planned ban on petroleum-based food dyes by the start of the next school year and stricter scrutiny of added sugars and seed oils in infant formulas. He also described an effort to promote clean-label innovation through new pathways outside the standard drug-approval system and plans to convene public discussions on topics ranging from peanut allergies to menopause treatment.

Tobacco, E-Cigarettes, and Enforcement Failures

Makary criticized FDA’s enforcement history with tobacco and electronic nicotine delivery systems (“ENDS”). He characterized prior actions, such as returning illegal vaping devices to their countries of origin rather than seizing them, as ineffectual and damaging to the agency’s credibility. He expressed frustration that many of the most dangerous products are manufactured in countries that ban them domestically but export them abroad with impunity.

Going forward, Makary committed to using FDA’s statutory authority to block such products from entering the U.S. market. He also outlined a more assertive enforcement strategy in coordination with the Office of Inspections, including a focus on devices clearly designed to appeal to children, such as vape pens disguised as toys or video games.

Increasing Predictability and Transparency of Vaccines

On vaccines, Makary announced an effort to increase public confidence through greater transparency and real-time monitoring. FDA plans to establish clearer regulatory expectations for vaccine developers and to modernize post-market surveillance using large electronic health record databases. Makary emphasized the importance of moving from passive reporting systems to active monitoring to ensure earlier intervention when safety issues arise.

Drug Costs, Economic Pressures, and Public Health

Makary also placed FDA’s mission in the context of broader economic pressures, noting that half of Americans have less than $400 in liquid assets. He urged the agency to recognize the financial burdens of chronic disease and called for upstream interventions, including dietary and environmental reforms, to reduce reliance on pharmaceuticals. His vision reimagines FDA not simply as a gatekeeper for new products, but as a catalyst for better prevention and more restrained prescribing.

Conclusion

Commissioner Makary’s remarks outlined an FDA in transition; one billed as more efficient, responsive, and aligned with the realities facing patients and regulators alike. Makary will champion targeted modernization, such as AI deployment and adaptive clinical trials, with a strong emphasis on strengthening the agency’s recently weakened scientific culture and public credibility. Whether addressing food safety, drug pricing, or enforcement lapses, Makary hopes for a recalibrated FDA, one that is downsized, pragmatic, and focused on addressing what the current administration sees as the root causes of public health risks.