While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
FDA Commissioner Marty Makary stated that he has built his leadership philosophy around a fundamental principle: the importance of experience coupled with continuous learning. “I believe in listening,” Makary emphasized during his fireside chat at BIO 2025. “What makes a great physician is not how much you know. It’s your humility, it’s your willingness to evolve your thinking on a topic as new data comes in.”
Since stepping into the FDA’s top position, Makary has consistently emphasized this core value as part and parcel to his new job. “The most important skill set in leadership in any capacity, be it running a company or running a regulatory body, is humility. It’s being willing to be truly open minded.”
While his experience as a medical professional is impressive, most of his background is squarely related to Johns Hopkins either as a surgeon or author. While he has written about health policy, he has no experience. This is a departure from previous commissioners such as Scott Gottlieb and Robert Califf, both whom had policy, regulatory, and clinical development experience.
As Health Secretary Robert F. Kennedy Jr. oversees massive upheaval of his department, Makary’s commitment to learning and humility raises a fundamental question: Would such extensive learning be necessary if the FDA hadn’t discarded experienced personnel?
The Expertise Exodus
The loss of institutional knowledge at the FDA has been swift, comprehensive and ongoing. Due to timing, many resignations and leave of absence announcements are in direct contradiction to the agency’s communication within the industry: while praising collaboration and expertise, the agency simultaneously is removing recognized experts in the very fields being discussed, creating deeply concerning knowledge gaps.
Though the transition of political appointments is not unusual; what is uncommon is that those in party-agnostic positions have also been told to resign or put on leave. This pattern has created a void in regulatory and drug development expertise.
Peter Marks, the longtime head of the Center for Biologics Evaluation and Research (CBER), was pushed out earlier this year and replaced by University of California, San Francisco professor and YouTube commentator Vinay Prasad. The industry and the world reacted to this replacement with stunned disbelief.
And at CBER’s sister division, the Center for Drug Evaluation and Research, nine years of FDA experience in acting head Jacqueline Corrigan-Curay was recently replaced by George Tidmarsh, a biopharma veteran with no previous experience working in government or regulation. With over 30 years of experience in the industry as a founder and CEO of biotech companies and as an academic, Tidmarsh has experience with clinical development in the private sector, but he lacks the expertise of his predecessors in both the scientific and regulatory aspects of drug evaluation.
The appointment of Tidmarsh is a particular problem as it is in direct contradiction with Kennedy’s and Prasad’s statements regarding the perceived revolving door relationship between regulators and the industry. Both Kennedy and Prasad were critical of Pfizer’s hire of Patrizia Cavazzoni, as its chief medical officer. “This is the core rot in American regulation,” Prasad wrote in his blog in February. “The revolving door politics. I find this behavior abhorrent, and it should be criminal.”
The consequences of removing HHS’ experienced personnel have become readily apparent in critical regulatory areas. Former FDA Commissioner Scott Gottlieb highlighted concerning deficiencies during his June 29, 2025 appearance on CBS’s Face the Nation, discussing problems with the newly reconstituted Advisory Committee on Immunization Practices (ACIP).
“A lot of the people who have been appointed don’t have deep experience, or any experience, quite frankly, in vaccine science,” Gottlieb told host Margaret Brennan. The lack of expertise led to what Gottlieb described as “awkward moments at that meeting. For example, you know, one member had to have explained to him the difference between an antibody prophylaxis and a vaccine.”
The Learning Paradox
Makary’s emphasis on challenging assumptions and being open to new ideas reflects admirable leadership qualities. However, starting from a position of inexperience is not the most effective approach to challenging assumptions built on experience. Experienced regulatory professionals understand both the scientific basis for decisions and the practical implications of regulatory changes. They can distinguish between assumptions that should be challenged and fundamental principles that reflect hard-won knowledge.
Regulatory agencies like the FDA develop institutional memory through decades of decision-making, scientific evaluation and policy implementation. This knowledge encompasses not just written guidelines and regulations but an understanding of how policies work in practice, awareness of past challenges and solutions, and insight into the scientific rationale behind regulatory approaches.
When Makary discusses the importance of humility and learning, he’s describing qualities that complement experience rather than replace it. The most effective regulatory leaders combine deep institutional knowledge with openness to new ideas and approaches. Experienced regulators understand which assumptions merit challenging and which fundamental principles reflect essential scientific and public health considerations.
The new FDA appears to prioritize change over continuity, discarding valuable institutional knowledge in pursuit of reform. While some policies and processes certainly needed updating, the wholesale removal of experienced personnel suggests a failure to distinguish between outdated approaches and essential expertise.
In an ironic twist, the upheaval could undermine President Donald Trump’s initiative to enhance the United States’ capabilities to be a leader in technology and innovation by driving experienced talent to other countries. While this fear is growing, the FDA has actively removed experienced personnel from key positions that spearheaded the United States into being a leader of innovation. Regulatory agencies in other countries are likely observing the FDA’s experience loss with interest.
In should be pointed out that, top HHS aides, Heather Flick Melanson, chief of staff, and Hannah Anderson, a top policy adviser, were recently let go by Kennedy, citing a loss of confidence. Beyond this statement no other comments have been made about the decision.
The Cost of Starting Over
The FDA had been considered the Gold Standard by other countries for decades, with many other nations following the FDA’s lead on approvals. The agency’s role in medical innovation extends far beyond approving individual products. The agency’s expertise and consistency have provided regulatory frameworks that enable long-term research and development planning. When companies cannot predict regulatory approaches or when key expertise is absent from review teams, the global innovation ecosystem suffers.
BioSpace reporting has highlighted multiple challenges facing the agency, from considerations of “speedier reviews to companies willing to lower drug costs” to broader concerns about layoffs and policy changes affecting rare disease development. The consequences of removing experienced personnel also extend beyond immediate operational challenges. As Francis Collins, former director of the National Institutes of Health (NIH), noted during his CBS 60 Minutes interview, the stakes are generational: “This is a generation that we might lose of young talent. They’re the ones who are going to make those next breakthroughs for cancer and diabetes and rare diseases, and many of them aren’t sure there’s a path [in the U.S.] anymore.”
The paradoxical situation at the FDA highlights a fundamental challenge in government reform: distinguishing between necessary change and valuable continuity. As regulatory agencies adapt to new scientific developments and evolving public health needs, they must rely on institutional knowledge and experienced personnel to maintain effectiveness. The agency’s current approach risks creating a cycle where lack of experience necessitates constant learning from external sources, potentially slowing decision-making and reducing regulatory predictability.
The question facing the FDA is whether it can rebuild essential expertise while maintaining the learning orientation that Makary champions, or whether the loss of experienced personnel will continue to create knowledge gaps that external consultation cannot fully address. The answer will significantly influence America’s ability to maintain its leadership in medical innovation and regulatory science.
