The FDA faces challenges to public confidence that require systematic reforms in its regulatory processes and communication strategies. Jeffrey Sonnenfeld and other faculty experts propose measures to restore trust through improved transparency and stakeholder engagement.
This commentary was originally published in Fortune. The views expressed are the authors’ own.
The FDA occupies a unique position at the intersection of science, medicine, public health, and innovation. Patients depend on the agency to evaluate therapies rigorously and fairly; innovators depend on predictable regulatory pathways; and investors depend on confidence that scientific evidence will guide decision-making.
That’s why it’s so disappointing and disheartening to see that only about half of Americans now say they trust the FDA, down from roughly three-quarters just two years ago—and the drop isn’t really about competence. It’s about independence. In KFF’s most recent tracking poll, fewer than half of respondents said they believed the agency can make decisions without political interference, and Harvard’s June 2026 survey found a majority believe federal health recommendations have become “too influenced by leaders’ personal beliefs” rather than evidence.
Restoring trust in the FDA will require a sustained commitment to transparency, consistency, scientific integrity, accountability, and modernization. If the agency can achieve those goals, it will strengthen both public health and America’s leadership in biomedical innovation. Recovery at the FDA will help ensure that lifesaving science translates to the public good through a process worthy of public trust. As pioneering microbiologist Louis Pasteur advised 140 years ago, “Science is the highest personification of the nation because that nation will remain the first which carries the furthest the works of thought and intelligence.”
A credible treatment plan for the FDA to recover lost trust after this period of damaging uncertainty begins with the principles that made the agency indispensable in the first place: safety, scientific rigor, transparency, and predictable application of evidence.
We have previously expressed concern that certain FDA decisions during the past two years created uncertainty regarding the agency’s longstanding commitment to evidence-based and predictable regulatory processes. Given the agency’s central role in evaluating the safety and effectiveness of medical products, maintaining public confidence in the scientific rigor, transparency, and consistency of FDA decision-making is essential for both patient welfare and biomedical innovation.
The stakes extend well beyond any single administration, commissioner, or product category. The FDA is the institution on which patients rely when they ask whether a medicine, vaccine, device, diagnostic, or food product has been evaluated with independence and care. It is also the institution on which physicians, scientists, biotechnology companies, medical device innovators, food manufacturers, and investors rely when making decisions that require years of planning and substantial capital investment. A strong FDA does not mean a permissive FDA. It means an agency that applies high standards clearly, consistently, and transparently.
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These concerns have extended across ideological and political lines, reflecting broader questions about regulatory consistency, the treatment of rare disease therapies, and the extent to which FDA decisions aligned with previously communicated scientific and regulatory expectations. Rare disease advocates have been especially vocal because, in many such conditions, patients have few or no alternatives. But predictability is just as important for common diseases. The rapid about-faces involving Moderna’s mRNA influenza vaccine application, for example, illustrated how abrupt shifts in regulatory posture can unsettle an entire sector, even when the product is intended for a widespread seasonal disease rather than a rare condition. When companies believe that agreed-upon trial designs, comparator choices, or evidentiary expectations may change late in the process, the resulting uncertainty affects not only one sponsor but the broader innovation ecosystem.
Under Acting Commissioner Kyle Diamantas, J.D., the agency has begun revisiting several high-profile decisions that generated substantial concern among patient organizations, clinicians, researchers, and investors. While it remains too early to assess the long-term impact of these changes, these follow-up reviews may represent an opportunity to restore confidence in the FDA’s decision-making processes. Reconsideration should not be understood as capitulation to industry or advocacy pressure. Rather, it is an opportunity for the agency to demonstrate that it can correct course when warranted, explain its reasoning clearly, and apply standards that are scientifically defensible and publicly intelligible.
Several examples illustrate the challenge. Replimune’s therapy for metastatic melanoma addresses a disease associated with substantial morbidity and mortality despite recent immunotherapeutic advances. uniQure’s gene therapy candidate for Huntington disease targets a progressive neurodegenerative disorder for which treatment options remain severely limited and mortality is high. Regenxbio’s therapy for Hunter syndrome addresses a rare X-linked inherited disorder that often results in serious multisystem complications and, in its severest form, increased mortality. Each case raises distinct scientific and regulatory questions. But together they have come to symbolize a broader concern: whether the agency is applying the same evidentiary expectations it previously communicated to sponsors, especially when products have advanced through expedited pathways designed for serious conditions with unmet need.
Critics of these decisions argued that the agency departed from prior regulatory commitments, placed insufficient weight on real-world evidence and external expert input, and applied evidentiary standards that differed from those previously communicated to sponsors. These controversies highlighted broader concerns regarding consistency, predictability, and transparency in the drug review process. The solution is not to lower FDA standards. Patients need confidence that approved therapies are supported by reliable evidence. But patients also need confidence that review standards will not shift unpredictably after sponsors and investigators have designed trials in consultation with the agency.
There are priorities for the work ahead. The FDA should provide timely, transparent resolutions for therapies that have generated substantial scientific debate and strong stakeholder interest. Delays in regulatory clarity can affect patients, clinicians, sponsors, and investors alike, particularly in therapeutic areas where treatment options are limited. The agency should prioritize timely review of products that had previously advanced through expedited pathways and for which sponsors had relied on established regulatory guidance. This does not require lowering evidentiary standards; rather, it requires ensuring that review standards are applied consistently and transparently.
The same principle applies to medical devices, diagnostics, digital health technologies, and vaccines. Modern medicine increasingly depends on products that do not fit old regulatory categories neatly: AI-enabled diagnostics, software-driven devices, adaptive clinical trial platforms, digital therapeutics, and rapidly updated vaccines. FDA oversight must keep pace with these technologies. That requires modernized IT systems within the agency; better capacity for data integration; stronger real-time post-market surveillance; and clear regulatory frameworks for digital tools, artificial intelligence, and software as a medical device. The FDA cannot credibly oversee 21st-century biomedical innovation if its own systems are built around 20th-century administrative processes.
A renewed FDA will want to acknowledge that “Food” is the first word in its name. If national leaders are serious about improving nutrition, reducing foodborne illness, evaluating food additives, and addressing exposures that may contribute to chronic disease, then the FDA’s food safety and nutrition mission requires more than slogans. It requires funding, inspectors, scientific staff, laboratory capacity, modern data systems, and transparent post-market review. Have we responded as quickly and efficiently to the current cyclosporiasis parasite outbreak as we could have, with the natural CDC and FDA partnership to protect the food supply of yore? Clear and predictable oversight of food and other non-pharmaceutical products is not a distraction from the agency’s medical product mission. It is central to the agency’s public health mandate.
This point is especially important for the Make America Healthy Again agenda. A serious prevention agenda should align naturally with a strong FDA. But that alignment will be credible only if it is grounded in high-quality science, public accountability, and sufficient resources. The agency was founded to protect the public from unsafe and misbranded products. That safety mission remains as important today as it was in the early 20th century, but the tools required to fulfill it have changed. Inspectors need modern systems. Regulators need access to timely and interoperable data. Post-market monitoring should be capable of detecting safety signals across drugs, devices, vaccines, foods, supplements, and digital technologies. Transparency should be the default, not an afterthought.
The next FDA commissioner should therefore be committed to scientific rigor, regulatory predictability, and transparency. The central qualification should not be ideological alignment, personal celebrity, or hostility toward any category of regulated product. It should be the ability to lead a complex scientific agency with independence, humility, operational competence, and respect for evidence. The Commissioner must be able to communicate clearly with Congress, industry, patient groups, clinicians, scientists, and the public while defending the agency’s scientific integrity against political interference from any direction.
Several unresolved cases still warrant timely, transparent resolution. Biohaven’s troriluzole for spinocerebellar ataxia stands out as one example. Despite three-year real-world evidence (RWE) data comparing the drug against a natural history cohort—which demonstrated a 50% to 70% slowing of disease progression and a significant reduction in falls—the agency issued a Complete Response Letter citing the systemic challenges inherent to external controls. Similarly, Sanofi’s tolebrutinib for non-relapsing secondary progressive multiple sclerosis, and Aldeyra Therapeutics’ reproxalap for ocular disease have each generated substantial concern among patients, clinicians, sponsors, or advocates. More broadly, reversing prior rejection decisions is not the same as completing the regulatory process. Where products had advanced through expedited pathways and sponsors had relied on prior FDA guidance, the agency should clarify whether additional evidence is required, explain the scientific basis for that requirement, and move decisively toward resolution.
But restoring trust will require more than revisiting a handful of controversial decisions. It will require rebuilding habits of institutional discipline: honoring prior regulatory commitments where scientifically appropriate; explaining departures from precedent; using advisory committees and external expertise constructively; expanding real-world evidence methods without abandoning rigor; modernizing IT; strengthening post-market surveillance; and adequately funding the inspectional and scientific workforce. A predictable FDA is not an easy FDA, but it is a fair FDA.
