The Emerging FDA Leadership Crisis

Recent reports indicate that President Donald Trump has approved a plan to dismiss Food and Drug Administration (FDA) Commissioner Dr. Marty Makary, marking a significant shift in the agency's top leadership. This development, first detailed by major outlets like The Wall Street Journal, stems from a series of high-profile disagreements and operational challenges during Makary's tenure. While the ouster has not been formally executed as of early May 2026, sources close to the White House suggest it is imminent, reflecting broader tensions within the Department of Health and Human Services (HHS) under Secretary Robert F. Kennedy Jr.

The FDA, responsible for ensuring the safety and efficacy of drugs, medical devices, vaccines, and food products in the United States, has been under intense scrutiny since the start of Trump's second term. Makary's potential exit would be the latest in a string of leadership changes, highlighting the administration's push to align the agency more closely with its Make America Healthy Again (MAHA) agenda, which emphasizes reducing chronic disease through better food policies, faster innovations, and skepticism toward certain pharmaceutical practices.

Who Is Marty Makary?

Dr. Marty Makary is a renowned surgical oncologist and professor at Johns Hopkins University School of Medicine. Before his FDA role, he authored best-selling books critiquing healthcare costs and modern medicine's shortcomings, positioning himself as a reform-minded voice. Makary gained prominence during the COVID-19 pandemic as a critic of some public health measures and FDA decisions, which resonated with conservative audiences and aligned him with figures like Kennedy.

Nominated in November 2024 following informal gatherings at Dr. Mehmet Oz's Florida residence—where Trump, Kennedy, and other health influencers bonded—Makar was confirmed by the Senate in March 2025 with a 56-44 vote, including rare bipartisan support from three Democrats. He pledged to streamline drug approvals, boost U.S. clinical trials, and tackle ultraprocessed foods, earning initial praise from MAHA proponents.

Timeline of Makary's Tumultuous Tenure

Makary's time at the FDA can be traced through key milestones:

• November 2024: Trump announces nomination amid MAHA momentum.
• March 2025: Senate confirmation; assumes role on March 25.
• Summer 2025: Early clashes emerge over vaccine policies and internal staffing post-Department of Government Efficiency (DOGE) layoffs.
• February 2026: Reverses initial denial of flavored vape flavors (blueberry, mango from Glas) after presidential pressure.
• April-May 2026: Renewed criticism over abortion pill review delays and multiple drug rejections; Supreme Court reinstates mail-order mifepristone access on May 4.
• May 8, 2026: WSJ reports Trump's sign-off on firing plan; Trump demurs publicly.

This chronology underscores a rapid escalation from promise to peril, exacerbated by the agency's post-layoff recovery efforts.

The Vaping Controversy at the Heart of Tensions

One flashpoint has been electronic cigarettes and nicotine products. Trump campaigned on protecting flavored vapes, viewing them as a harm-reduction tool for adult smokers transitioning from traditional cigarettes. Makary, however, prioritized youth protection, initially blocking flavors like blueberry and mango from Los Angeles-based Glas, citing addiction risks among teens.

Over a weekend in early May, Trump personally upbraided Makary during calls from Florida, urging faster approvals to appeal to young MAGA voters. The FDA relented, but the delay fueled perceptions of Makary as obstructive. David Williams of the Taxpayers Protection Alliance noted Trump's first-term promises went unfulfilled under prior leadership, amplifying frustration. This episode illustrates the administration's balancing act between innovation and regulation.

Abortion Pill Oversight Draws Fire from Conservatives

The handling of mifepristone, a key abortion pill used in medication abortions comprising over half of U.S. terminations, has alienated social conservatives. Anti-abortion advocates, including Susan B. Anthony Pro-Life America's Marjorie Dannenfelser, accused Makary of indifference, demanding his immediate firing for stalling a promised safety review and generic approvals.

Groups met White House staff on May 8 amid midterm election pressures, where abortion remains pivotal. Despite Makary's denials, the Supreme Court's May 4 decision to allow mail-order resumption intensified calls for stricter controls. This rift highlights ideological divides within Trump's coalition, pitting MAHA reformers against traditional pro-life factions. For more on the legal backdrop, see the Supreme Court ruling.

Photo by Pau Casals on Unsplash

Drug Approval Denials Spark Biotech Backlash

Biotech firms and rare-disease advocates have lambasted Makary for rejecting promising therapies, stalling innovation and patient access. Notable cases include:

• Replimune's melanoma therapy, rejected twice, prompting a 22% stock surge post-ouster reports.
• Atara Biotherapeutics, Pierre Fabre Pharmaceuticals, Regenxbio, and Replimune's rare-disease candidates.
• Moderna's mRNA flu vaccine reversal and uniQure gene therapy trial demands.

Former Sen. Rick Santorum publicly decried Makary for ousting experienced reviewers like Richard Pazdur, replacing them with "anti-Trump leftists," allegedly driving biotech overseas. The Wall Street Journal's editorials, over half a dozen strong, questioned if any official caused more headaches. Industry leaders anticipate stability post-Makary, eyeing faster pathways under new leadership. Detailed analysis appears in the Wall Street Journal.

Internal Turmoil and Leadership Exodus

The FDA has endured unprecedented upheaval: thousands departed amid DOGE cuts, morale plummeted, and the Center for Drug Evaluation and Research cycled through five directors since early 2025—Peter Marks, Rachael Anatol, Richard Pazdur, Jacqueline Corrigan-Curay, and Vinay Prasad (ousted twice). Critics like Santorum blame Makary's personnel choices, while Makary touted morale boosts and deregulation wins like natural food dyes.

HHS dynamics worsened matters, with Makary clashing with counselor Chris Klomp over hires. Kennedy eyed a figurehead role for Makary, signaling eroding confidence. This vacuum risks delayed approvals and eroded expertise, as former FDA Chief Scientist Jesse Goodman warned of rebuilding needs.

Trump's Response and Administration Dynamics

Trump's public stance remains coy: "I’ve been reading about it, but I know nothing about it," told reporters on May 8. Privately, frustration mounted via direct calls, influenced by HHS pushes rather than White House initiative. White House spokesman Kush Desai praised the team's "historic victories," sidestepping the issue.

Makary, caught off-guard, assured confidants of Trump's support post-vape approval, only for reports to solidify his fate. This mirrors HHS patterns, including CDC and NIH vacancies.

Stakeholder Reactions: A Divided Response

Views split sharply:

• Pharma/Biotech: Relief; Replimune shares jumped, firms predict predictability.
• Anti-Abortion: Jubilation; Dannenfelser deems it overdue.
• MAHA Allies: Defense; Influencer Alex Clark blasted "swamp creatures" targeting Makary's scrutiny.
• Public Health: Concern over politicization and expertise loss.

Explore perspectives in CNN's coverage here.

Potential Replacements and Transition

No permanent successor named; acting options include Deputy Commissioner Kyle Diamantas, FDA food chief, Grace Graham, or Lowell Zeta. Nominees floated: ex-Commissioner Stephen Hahn, Acting Commissioner Brett Giroir. Kennedy's input looms large, prioritizing MAHA alignment.

Transition risks further delays in a backlog-prone agency.

Photo by History in HD on Unsplash

Implications for Public Health, Industry, and Policy

This shakeup could accelerate approvals, aiding biotech (U.S. trials up?) but risking safety oversights. Vaping access might expand, abortion restrictions tighten pre-midterms. FDA's credibility, already strained, faces tests amid expertise gaps. Long-term, it signals Trump's hands-on health overhaul, potentially reshaping chronic disease fights but inviting lawsuits and congressional probes.

Stakeholders watch for stability; patients with rare diseases urge balanced rigor. NYT details the stakes here.

What Lies Ahead for the FDA

Makary's exit, if finalized, caps a volatile chapter, paving for realignment. Success depends on swift leadership install, staff retention, and bridging divides. Midterms loom, with health policy electoral weight. The FDA's evolution under Trump 2.0 remains pivotal for American health innovation and safety.