Yale, Harvard Experts Call for Greater FDA Transparency To Rebuild Public Trust
A group of prominent academic and public health experts is urging FDA to embrace greater transparency, scientific independence and regulatory consistency, arguing that public confidence in the agency has eroded amid concerns over political interference and shifting regulatory standards.
In a commentary published Tuesday in Fortune, Jeffrey Sonnenfeld of the Yale School of Management, Yale School of Public Health dean Megan Ranney, former Yale School of Public Health dean Sten Vermund, Harvard neurologist Patricia Greenstein and Yale Chief Executive Leadership Institute research director Steven Tian said restoring trust in the FDA will require renewed commitments to scientific rigor, predictable regulation and modernization of the agency's operations.
The authors cited polling showing that public trust in FDA has fallen sharply over the past two years, with fewer Americans believing the agency can make decisions free from political influence. They attributed much of that decline to public criticism of the agency by HHS secretary Robert F. Kennedy Jr. and what they described as instances in which political leadership overrode the recommendations of career scientists.
“The FDA occupies a unique position at the intersection of science, medicine, public health, and innovation," the authors wrote, arguing that confidence in the agency is essential not only for patients but also for physicians, researchers, biotechnology companies and investors. The commentary contends that recent regulatory decisions have raised questions about whether FDA has consistently applied previously established evidentiary standards, particularly for therapies addressing serious diseases with unmet medical needs.
Among the examples cited were regulatory decisions involving Replimune's melanoma therapy, uniQure's Huntington disease gene therapy candidate and Regenxbio's experimental treatment for Hunter syndrome. The authors said those cases have become symbols of broader concerns that the agency has changed regulatory expectations late in the review process after sponsors designed clinical programs in consultation with FDA.
The group also pointed to recent uncertainty surrounding Moderna's influenza mRNA vaccine application as an example of how abrupt regulatory shifts can reverberate across the biotechnology sector.
The authors welcomed efforts by acting FDA commissioner Kyle Diamantas to revisit several controversial decisions but stressed that reconsideration should demonstrate scientific consistency rather than simply respond to industry pressure.
They also urged the FDA to provide timely decisions on several applications that have generated significant public interest, including Biohaven's troriluzole for spinocerebellar ataxia, Sanofi's tolebrutinib for non-relapsing secondary progressive multiple sclerosis and Aldeyra Therapeutics' reproxalap for ocular disease.
Beyond individual product reviews, the commentary calls for broader reforms, including expanded use of advisory committees, greater transparency when regulatory standards change, increased use of real-world evidence where appropriate, modernization of FDA information technology systems and strengthened post-market surveillance capabilities.
The authors also argued that the FDA's food safety responsibilities deserve greater attention and resources, saying investments in inspectors, laboratories, data systems and scientific staff are necessary to support the agency's public health mission.
Looking ahead, they said the next FDA commissioner should be selected based on scientific leadership, operational competence and independence rather than political ideology.
"A predictable FDA is not an easy FDA, but it is a fair FDA," the authors concluded.