It’s Time for a Reset at the FDA
Personnel turmoil at the Food and Drug Administration (FDA) has regrettably become a defining feature of President Donald Trump's second term.
What began as a push to streamline bureaucracy and empower innovators has instead exposed deep structural weaknesses inside one of America's most important health agencies.
The revolving door of senior officials, conflicting agendas, and managerial infighting has turned a mission of reform into a lesson in dysfunction.
The recent resignation of Dr. George Tidmarsh is only the latest and perhaps clearest sign that it’s time for a reset at the FDA.
When President Trump nominated Dr. Marty Makary to lead the agency, expectations were high. His mandate under the "Make America Healthy Again" (MAHA) initiative was clear: cut the red tape, modernize approvals, and ensure the U.S. remained the world’s leader in biomedical innovation.
Early staffing reductions at the FDA were meant to eliminate waste and bureaucracy.
But in practice, the shake-up created a leadership vacuum and left the agency vulnerable to ideological capture and managerial drift.
That vacuum was quickly filled by Dr. Vinay Prasad, a self-described progressive who once derided President Trump as "perhaps the worst president in the history of the Republic."
Despite that record, Prasad was elevated to serve simultaneously as the FDA's Chief Medical Officer, Chief Scientific Officer, and Director of the Center for Biologics Evaluation and Research (CBER) — a concentration of authority rarely seen at the agency.
After months of internal turmoil and mounting complaints about his leadership, Prasad was dismissed, only to be quietly rehired a few weeks later at the request of Makary.
Instead of accelerating access to lifesaving therapies, he has continued to slow them down, consolidating influence, marginalizing career experts, and fostering what insiders describe as a culture of fear.
In theory, Makary’s decision to bring in biotech veteran Dr. George Tidmarsh as Center for Drug Evaluation and Research (CDER) was intended to balance out Prasad’s approach and restore order.
In reality, it ignited open warfare.
Tidmarsh's own ethical controversies — most notably allegations that he used his position to target a former business associate — forced his resignation just this past week.
That departure leaves an already fractured FDA with even less leadership and even greater uncertainty over who is steering the agency.
These episodes are unfortunate symptoms of a deeper institutional problem: the breakdown of accountability and coherence within an agency critical to public health and economic competitiveness.
In recent months, internal power struggles have stalled reviews, driven out experienced scientists, and left small biotech firms working to deliver breakthrough cures without clear guidance or timely decisions.
The consequences are serious.
The U.S. once led the world in drug and gene-therapy innovation. Now, uncertainty and delay are driving trials and licensing deals overseas.
Licensing for Chinese-developed drugs has skyrocketed from less than 3% of activity five years ago to nearly 40% today.
Each failed or delayed approval at the FDA represents not just a missed business opportunity but a blow to American leadership in biotechnology — and a lifeline handed to Beijing.
For families waiting on experimental treatments, this bureaucratic infighting has human costs. Earlier this year, the agency rejected Ultragenyx’s UX111 on technical manufacturing grounds, despite overwhelming clinical evidence that the therapy was safe and represented the only potential treatment for a fatal neurodegenerative disease.
Around the same time, the FDA halted distribution of Sarepta's Elevidys, the only approved therapy for Duchenne muscular dystrophy, citing procedural concerns over trial data rather than new safety risks.
Both cases exemplify a pattern in which process has overtaken purpose, leaving desperate patients with fewer options and little recourse.
Having served on the U.S. House Committee on Oversight, I've seen what happens when agencies lose their sense of mission.
The FDA's recent dysfunction is not just a personnel problem — it’s a governance problem. When the individuals at the top pursue personal, political, or reputational agendas, the result is paralysis.
And when that paralysis occurs inside an agency tasked with approving lifesaving drugs, it endangers both patients and America's standing as the global leader in medical innovation.
A genuine reset is now unavoidable.
Makary may be trying to signal this with his swift appointment of Dr. Richard Pazdur to replace Tidmarsh at CDER, but the reality is that the FDA Commissioner and his cronies must be removed to correct the agency’s internal dysfunction and ideological drift.
The White House and HHS Secretary Robert F. Kennedy Jr. should move quickly to restore credibility and competence, starting with a top-to-bottom review of FDA leadership.
If that cannot be accomplished internally, Congress may need to exercise its oversight authority to ensure accountability.
That step should be a last resort — but it may soon be the only option left.
President Trump’s first term showed what effective reform at the FDA can deliver: right-to-try, record drug approvals, and the fastest vaccine rollout in history.
His second term must recapture that focus on innovation and results.
The path forward requires more than slogans it requires leadership that prioritizes science and patients over politics.
Very recently we saw a preview of what the 2026 midterm elections could possibly be.
President Trump has been clear on his healthcare agenda; he wants to protect American patients and American innovation; unfortunately, his current FDA is doing the opposite.
The FDA can still be reformed, but only if its leaders remember who they serve.
The mission is not to protect bureaucratic turf or indulge ideological battles.
It is to Make America Healthy Again.
Reorienting towards that mission will require some serious work, and it should start now.
Mike Flanagan represented the 5th District of Illinois in the U.S. House of Representatives. For More of his Reports — Click Here Now.
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