The Trump administration recently celebrated one year of embracing the movement to Make America Healthy Again. Unfortunately, many of these successes are overshadowed by slapdash decision-making at a key health agency, which significantly undermines the administration’s goals, threatens treatment access, choice, and safety for American patients, and hinders our longstanding reputation as a world leader in medical innovation.
For over 100 years, the Food and Drug Administration (FDA) has played a vital role for American patients and drug manufacturers, establishing rigorous, science-based standards and clear approval processes for lifesaving treatments. Prior to this year, the FDA has been considered the “gold standard” among global regulatory bodies. This reputation, however, has been severely diminished during the past year by agency decision-making that has left Americans baffled and concerned.
In 2025, the FDA slashed its sizeable workforce by nearly 4,000, but the arbitrary nature of the dramatic reduction in force was evident in the subsequent rehiring of some of those staff members, prompting widespread alarm. Turnover has not been isolated to rank-and-file staff, as the Center for Drug Evaluation and Research (CDER) churned through four leaders over the course of 2025, including cancer researcher and founder of the FDA’s oncology center Richard Pazdur, who would go on to retire a mere three weeks into his tenure.
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The instability continued when Vinay Prasad — previously fired in July 2025 and rehired less than two weeks later as Director of the Center for Biologics Evaluation and Research — was announced to be departing yet again. This leadership turmoil is emblematic of the broader chaos engulfing the agency.
Pazdur warned earlier this year that the chaos at the FDA has extended to the agency’s approach to its core regulatory functions, and recent developments have unfortunately proven him correct. The guidance coming out of the FDA is not only shortsighted but also often hypocritical and directly self-contradictory. The FDA’s management has lost sight of its North Star — its commitment to following the science, which previously made it the most trusted regulator in the world. Course-correction is needed to ensure the core functions of safety, efficacy, and affordability of medications, and to regain Americans’ trust.
Take Moderna’s recent experience navigating contradictory and confusing FDA messaging during the vaccine approval process. In February, the FDA refused to review Moderna’s new mRNA flu vaccine due to issues with the company’s comparator study design, which Moderna claimed contradicted earlier agency guidance. After several weeks of industrywide outcry at the decision, the FDA reversed course, but the damage was already done. The refusal came mere weeks after Moderna announced it was not planning to invest in late-stage studies of several experimental vaccines. This short-sighted, undisciplined management undermines America’s leadership in medical innovation and the proven economic benefits that flow from it.
Other manufacturers have similarly faced abrupt rejections of applications for new treatments over clinical trial issues, including a cell therapy for patients with Dechenne muscular dystrophy, a viral-based treatment for patients with advanced skin cancer, and a cell therapy for patients with white blood cell disorder, the rejection of which was a reversal of the FDA’s position over five years of meetings. These mounting inexplicable decisions are daily affecting American patients by delaying treatments, stifling competition for affordable medications, and undermining America’s leadership in scientific discoveries.
While the FDA has begun requiring even more evidence for certain vaccines and some therapies, it has taken the opposite approach for other drugs, including biosimilars, without providing a scientific justification for significant policy changes. In the fall, the FDA released guidance stating that it would no longer require switching studies that demonstrate that a biosimilar is safe and effective when compared to its reference product. Additionally, the agency recently announced that manufacturers can file for drug approval with one pivotal trial, backed by confirmatory evidence, rather than the two pivotal trials that the FDA has consistently relied on. Senior leadership at the FDA defended the measure, arguing that over-reliance on two trials no longer makes sense, and said they expect a surge in drug development in response.
Cutting regulatory requirements on the one hand and increasing them on the other does not inspire faith in the agency’s decision-making. Drug development can take a decade or longer and cost hundreds of millions of dollars. Constantly shifting regulatory guidance will only make companies less inclined to invest in new and innovative treatments.
In the case of Moderna’s flu vaccine, President Donald Trump reportedly prompted the FDA’s change of heart. While it is reassuring that Trump and some in the administration understand what is at stake, counting on case-by-case presidential intervention is no substitute for steady, predictable standards. The president needs a leader at the FDA who understands its mission and has the ability and prudence to manage this vital agency without unpredictability and dysfunction.
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The impact of this dysfunction ultimately falls on American patients. If the FDA’s seemingly arbitrary and inconsistent decisions appear ungrounded in science, the hard-earned public confidence in the medicines it approves will suffer. Further, if the agency’s unpredictability makes manufacturers less willing to invest in incremental and breakthrough innovations, it could delay or prevent these treatments from reaching patients and may even make manufacturers think twice about any investment in the U.S. at a time when our global adversaries are eager to gain any advantage.
If a healthy America is the goal, then patients and manufacturers deserve a steady hand that builds trust and innovation, not continued chaos and confusion.
Dr. Cristina V. Beato is an Albuquerque physician and former acting assistant secretary for health at the U.S. Department of Health and Human Services.