This week, newly appointed FDA commissioner Marty Makary and Center for Biologics Evaluation and Research director Vinay Prasad published an ambitious set of priorities for the US Food and Drug Administration, stoking debate over the agency´s future. Both Makary and Prasad, previously respected medical academics, shifted into controversial territory during the covid pandemic by voicing contrarian views on masking, vaccines, and lockdowns—polarizing the science community and drawing scrutiny to their new regulatory roles. Coupled with sweeping layoffs at the FDA, their platform has intensified concerns about drastic change in America’s approach to food and drug safety.
Makary, who initially supported pandemic restrictions before reversing his stance, has criticized the FDA’s leadership and drug approval paradigms as outdated and inconsistent. Prasad, renowned for advocating rigorous, evidence-based medicine before the pandemic, called for stricter standards on drug approvals but later alienated many peers with inflammatory remarks linking pandemic measures to authoritarian regimes. Both now propose that the FDA broaden its investigations to include ultraprocessed foods, additives, and environmental toxins—aligning with RFK Jr.´s agenda and signaling a possible expansion of agency focus beyond established mandates. Experts note that such moves lack clear definitions and could complicate the FDA’s core mission, which historically centers on evaluating product safety and efficacy, not broad nutritional policy.
The leadership duo further argues for streamlining drug approvals, suggesting reforms like submitting final paperwork early and reducing clinical trial requirements from two pivotal studies to one. Critics warn that these measures might allow unsafe or ineffective drugs onto the market, replicating high-profile missteps such as the premature approval of Alzheimer’s drug aducanamab, later retracted. While calls to accelerate cures echo existing FDA expedited pathways, there is unease that lowering evidentiary standards may compromise patient safety. Makary and Prasad also tout the use of generative artificial intelligence in FDA scientific reviews, reflecting continued enthusiasm for automation in regulatory science—a trend already underway with over a thousand FDA-approved medical devices employing such technology. Yet the challenge remains whether these stated priorities can materialize, given mounting budget cuts, research restrictions, and workforce reductions across federal health agencies. Many experts see a discord between the new leaders´ rhetoric on evidence-based practice and the broader political realities shaping federal science policy.
As the FDA navigates this new era, the full impact of these proposals—ranging from artificial intelligence-driven reviews to shifts in food regulation—remains uncertain, especially against a backdrop of institutional turbulence and conflicting agendas.
