The FDA is becoming deeply compromised and increasingly at risk of being permanently transformed in ways contrary to its mission, history and culture.
The governing style favored by President Trump is “move fast and break things.” At the FDA— an agency tasked with safeguarding consumers in their use of food, tobacco and medical products—following such a philosophy could mean people die.
As a policy analyst, former government official, advocate for FDA resources and author of the FDA Matters blog, I have spent nearly every day, over many years, trying to understand and explain the FDA. The agency’s history and culture enshrine predictability and expertise as core values. In my opinion, those values are antithetical to Trump’s norm-breaking approach to policymaking.
Some things are clearly going in the wrong direction for the agency, and the pace seems to have accelerated in recent weeks. As a result, I wonder if we are reaching the point where reaffirming FDA’s mission may not be sufficient to correct the situation.
I’m reminded of a quote often misattributed to Vladimir Ilyich Lenin: “There are decades where nothing happens; and there are weeks where decades happen.” For the FDA, we could be in the midst of decades of change in short order.
I am starting to worry: Will the resulting FDA still be true to its mission and worthy of its reputation as the global gold standard?
Causes for Concern
FDA Commissioner Marty Makary recognizes the importance of leadership stability at the agency and believed he had finally secured it with the appointment of Richard Pazdur as director of the Center for Drug Evaluation and Research (CDER). But Pazdur’s sudden decision to retire has rocked the boat once again, as the agency has lost almost every senior leader from a year ago. It is reason to look more broadly at where the FDA is heading.
For example, even the slightest hint that politics and favoritism are involved diminishes the confidence the American people—and regulatory agencies worldwide—have in FDA product decisions. So, when someone at the FDA (likely not the Commissioner) recently invited two members of Congress to attend a meeting with a product sponsor, according to reporting by Bloomberg, alarm bells went off in my head. The invitations were eventually withdrawn, but the question lingered: Whose understanding of FDA’s role was so deficient that this seemed like a good idea?
Of late, agency proposals and actions have increasingly reflected similar misunderstandings of the agency.
Late last month, Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad announced via e-mail a massive set of proposed changes in vaccine policies and standards. There was no public notice or sign of broad discussion with internal or external experts. He welcomed staff debate, but there is no evidence that those are planned or have been occurring on other policy shifts. Shockingly, Prasad suggested that anyone who disagreed publicly with these fiat changes should resign. Insiders tell me that a slew of policies, many of them problematic, are being advanced similarly—without any input from FDA staff or outside experts.
No one in authority has the institutional memory to recall how the agency operated on a good day.
In parallel, science-based decision-making is being pushed aside in favor of decisions that are not grounded in science or are built on the misinterpretation of data. The rapid destruction of the CDC has been driven by Secretary Kennedy’s prejudices about vaccines dictating policy rather than data and reasoning.
It is now clear that Prasad and Acting CDER Director Tracy Beth Høeg are similarly committed to anti-vaccine policies at the FDA. Høeg has initiated a broad search of deaths tied to vaccines, which may indeed show a few deaths among millions of inoculations. That’s worth knowing, but I fear the research will be used as a weapon against vaccinations that have also saved millions of lives. A similar exercise is reportedly underway with regard to anti-RSV antibodies.
Meanwhile, the agency’s new proposed “one pivotal trial policy” appears to undermine its commitment to patients. Drugs are often approved based on one well-controlled clinical trial and FDA has supported this option since the late 1990s and has issued guidance on the topic to sponsors as recently as 2023.
Nonetheless, the FDA is proposing a massive precedent shift: from, essentially, “two studies but we will listen to any reasonable argument that one is sufficient” to “only one study is required unless we tell you a second is needed.”
The practical difference may be small, but the message is all wrong. Second studies can be important. I know because I have worked on drugs and biologics that had a great first study and didn’t fare as well on the second. Shifting to one-trial is also inconsistent with recent FDA rejections citing a need for additional evidence and Prasad’s ongoing rhetoric about the number of unsafe drugs on the market.
Also of concern is the lack of public and expert input, internal discussion, disagreements and even dissent—all of which are intrinsic parts of an FDA culture that is intentionally more bottom-up than top-down in its decision-making process. This is a source of great strength for the agency. Unfortunately, these practices are falling by the wayside under the new administration.
Instead of tough, balanced “persuade us” advisory committees, we are now offered carefully selected ad hoc “expert panels” brought in to rubber-stamp a particular position. In a more general sense, independent and staff expertise is not being sought or valued.
Unfortunately, the FDA no longer operates in a mode where it can easily self-correct: bottom-up communication is rare, and no one in authority has the institutional memory to recall how the agency operated on a good day. Historically, leadership turnover at FDA has been dispersed over time, so no one departure created such a void. This year has been different: near-total turnover from the new administration’s dismissals of senior leadership and DOGE lay-offs.
If FDA doesn’t correct course soon, it will experience continued staff turnover with the further loss of institutional memory, and find itself with a serious recruitment problem for an agency that is no longer seen as wholly committed to consumer protection and public health.
FDA’s mission, history and culture have preserved the agency and kept it strong even in the face of considerable adversity. Change is welcome, but the wrong type threatens the way forward.
The prescription is clear—maximize predictability and rely on expertise—but it is uncertain whether FDA’s leadership will take the medicine.
