Trump to fire Marty Makary? It’s about time for change at FDA
The article deploys charged language ('disaster,' 'blistering letter,' 'regulatory muck') and frames FDA leadership removal as an imperative rather than a contested political decision. It centers corporate voices (biotech CEOs, BIO CEO Crowley) and hawks (RFK Jr., Gottlieb) while omitting regulatory safety rationales or perspectives from public health advocates. The framing subordinates bureaucratic caution to market efficiency and positions China competition as an existential threat, a common conservative/nationalist rhetorical move that justifies deregulation.
Primary voices: elected official, corporate or institutional spokesperson, academic or expert, media outlet, international body
- This article does not address FDA safety approval rationales or scientific justifications for review timelines.
- This article does not include perspectives from patient safety advocates, public health organizations, or Democratic officials who may support FDA caution.
- This article does not contextualize drug rejection increases or missed deadlines against specific safety incidents or regulatory reasons.
- This article does not mention Makary's defense of his leadership or FDA performance metrics beyond those cited by critics.
Framing may shift if drug safety crises emerge post-Makary replacement, or if biotech competition with China develops differently than projected.
Establishment framingPro-capital framingAdvocacy tone
According to the Washington rumormongers, President Donald Trump has decided to fire Marty Makary, the administrator of the Food and Drug Administration, and, to be as plain as possible about it, it’s about time.
Makary has been a disaster, keeping Trump and Health and Human Services Secretary Robert F. Kennedy Jr. from accomplishing anything major. Instead, he’s taken it upon himself to stand athwart many of the Make America Healthy Again initiatives that, as campaign promises, played a significant role in the 2024 election.
How the FDA bureaucracy is blocking the president’s health agenda, leaving millions of patients without access to necessary care, hasn’t gotten the coverage it deserves. The system incentivizes delay over action, and many don’t have the time to wait.
Trump is following through on his mandate to fix healthcare, nonetheless. He’s slashing drug prices, though not always in the most market-friendly way, empowering Kennedy to clean house, and eliminating regulations that raise costs without improving the quality of the service delivered. His MAHA movement speaks to millions of people who believe the healthcare complex profits from their suffering.
The Right to Try Act, a major achievement of Trump’s first term, was a commitment to terminally ill people that they would not die waiting on bureaucratic approval of their use of experimental treatments recommended by a physician.
Patients are still begging for what, by law, should be theirs. Approvals and pathways remain closed as the FDA, mired in regulatory muck, fails to act. Drug rejections have increased by 50%, missed application review deadlines tripled in 2025 as approvals dropped 14% over the later part of the year, and the approval pipeline continues to bottleneck while output stalls. The list goes on.
America has built the greatest biotech industry known to man through speed, audacity, and an unwavering commitment to innovation, a competitive edge that the FDA is dismantling from the inside out.
To address the problem, in late 2025, U.S. biotech CEOs sent Makary a blistering letter that documented his agency’s failings. It contained a litany of missed approval deadlines, canceled advisory committee meetings, pulled discussions with drug developers, and a take-it-or-leave-it posture that shuts companies out. For the smaller firms, dealing with these problems often means collapse, ending the development of promising treatment.
Meanwhile, patients wait. Scott Gottlieb, a former head of the FDA himself, once warned that the “ongoing assault on that drug-development enterprise threatens to quickly reinstate frustrating delays for American consumers, particularly impacting rare diseases and areas with significant unmet medical needs.”
Gottlieb’s caution is no longer advisory. The problems he foresaw in the U.S. market are here, while China closes the gap in biotech development. Biotechnology Innovation Organization CEO John Crowley testified before the Senate that it could even surpass the United States within two to three years. A bipartisan commission put it more starkly: “Without immediate and bold action, the U.S. will cede its dominance in biotech to China in the next few years.”
China has a 20-year national biotech strategic priority. Beijing and Shanghai are home to more biotech research and development space than Boston. China accounts for nearly 30% of all global clinical trials, closing fast on America’s 35% share. Meanwhile, a dysfunctional FDA allows America’s competitive edge to dull.
The FDA’s bureaucratic paralysis will lead to disaster. It needs new leadership, an outsider who can bring a new paradigm to its conduct. The Center for Strategic and International Studies warned in April 2026 that “the more immediate risk stems from domestic policy choices that could alter the incentives underpinning the U.S. innovation system.” That’s just a polite way of saying America is shooting itself in the foot.
Trump and Kennedy have the vision. The public gave them a mandate. The FDA needs new leadership that recognizes the only thing preventing real results that save lives and improve cures is a change in the corporate culture that reminds everyone the Biden people are no longer in charge.
Removing Makary would go a long way toward making that a reality.
Peter Roff is a former UPI and U.S. News and World Report columnist who is now affiliated with several public policy organizations. He is an experienced journalist and commentator who has contributed to various media outlets and is a highly regarded political analyst. You can reach him at RoffColumns AT GMAIL.com and follow him on social media @TheRoffDraft.
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