Agency: U.S. Food and Drug Administration (FDA) Role: 27th Commissioner of Food and Drugs (March 2025–May 2026) Severity: P1 — Documented pattern of regulatory changes that materially weakened drug safety standards Party/Affiliation: Republican-aligned; Make America Healthy Again Commission

Bio and Background

Education

• B.A., Bucknell University
• M.D., Thomas Jefferson University
• M.P.H., Harvard T.H. Chan School of Public Health
• Surgical residency, Georgetown University
• Sub-specialty training in surgical oncology and gastrointestinal surgery, Johns Hopkins University[1][2]

Pre-Government Career

Makary was a surgical oncologist at Johns Hopkins Hospital, where he held the Mark Ravitch Endowed Chair in Gastrointestinal Surgery and served as chief of Islet Transplant Surgery. He founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and co-developed a surgical safety checklist used in operating rooms worldwide. He is a member of the National Academy of Medicine.[1][2][3]

Makary is the author of several books on healthcare, including The Price We Pay (2019), which examined the cost of healthcare in the United States, and Blind Spots (2019), on groupthink in medicine.[2]

COVID-19 Prominence

During the pandemic, Makary was an early advocate for universal masking and vaccines. However, he later became a prominent critic of vaccine mandates, prolonged school closures, masks for young children, and universal booster recommendations. He appeared frequently on Fox News programs, including “Tucker Carlson Tonight,” criticizing government health officials.[3][4]

In February 2021, Makary predicted in a Wall Street Journal op-ed that COVID-19 would be “mostly gone by April” due to natural immunity and vaccination — a prediction that proved incorrect as the Delta and Omicron variants subsequently caused major surges in cases and deaths.[3][4]

Makary and Johns Hopkins colleagues conducted studies on natural immunity published in JAMA, contributing to debates over vaccine mandates for individuals who had recovered from COVID-19.[1][2]

Role and Function

The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation. The agency also oversees the manufacturing, marketing, and distribution of tobacco products. The FDA regulates approximately one-fifth of the U.S. economy.[1][2]

As Commissioner, Makary announced 50 major regulatory reforms, focused on accelerating drug development, modernizing review processes, and aligning the agency with the administration’s Make America Healthy Again priorities. He served under HHS Secretary Robert F. Kennedy Jr.[5][6]

Documented Actions

Single Pivotal Trial Default

Action: Announced that FDA would move from the long-standing two-trial standard for drug approvals to a single pivotal trial as the default for most therapies.

Date: February 2026

Evidence: Makary and FDA Deputy Commissioner Vinay Prasad announced the shift in a policy statement. “Going forward, the FDA’s default position is that 1 adequate and well-controlled study, combined with confirmatory evidence, will serve as the basis of marketing authorization of novel products.” The change replaced guidance that, since 1998, had generally been interpreted as requiring two clinical studies to establish safety and efficacy.[7]

Significance: This represents one of the FDA’s largest regulatory shifts in decades. Critics expressed concern that reduced evidentiary requirements could lead to approval of drugs that would have failed a second trial. Supporters argued it would accelerate access to needed treatments while maintaining safety through confirmatory evidence requirements.

Commissioner’s National Priority Voucher (CNPV) Program

Action: Created a pilot program to dramatically reduce drug review timelines from six or more months to one to two months for select applications.

Date: June 2025

Evidence: The CNPV program used a multidisciplinary “tumor board-style” review process to expedite approvals for drugs addressing public health emergencies, breakthrough therapies, unmet medical needs, supply chain resilience, and affordability. Seven drugs completed review through the program as of May 2026.[7][8]

Controversy: The program faced questions about its legal authority, as it bypassed established statutory review timelines. Questions were also raised about the program’s rigor after bitopertin, a rare disease drug granted a CNPV in October 2025, was subsequently rejected by the FDA.[5][7]

Hormone Replacement Therapy Label Changes

Action: Directed the removal of black box warnings from estrogen hormone replacement therapy (HRT) products prescribed for menopausal symptoms.

Date: November 2025 (announced); February 2026 (finalized)

Evidence: Makary convened an “expert panel” in July 2025 to discuss HRT labeling. In November, the FDA announced it would ask drug companies to remove black box warnings for menopausal hormone therapy, arguing that the 2002 Women’s Health Initiative study had been “misinterpreted” and had “resulted in a distorted perception of risk” that deterred women from necessary treatment.[9][10]

Controversy: The FDA also separately initiated labeling changes for acetaminophen (Tylenol) in September 2025 to reflect what the agency characterized as an association between use during pregnancy and autism — a claim for which no causal relationship has been established. Health policy observers noted that these labeling decisions appeared to be driven by commissioner and HHS leadership preferences rather than standard FDA scientific review processes.[10]

COVID-19 Vaccine Policy Framework

Action: Implemented a risk-based framework for COVID-19 vaccines that limited routine booster authorization to high-risk groups and individuals over 65, requiring more rigorous clinical trial data for the general population.

Date: 2025–2026

Evidence: Makary and Prasad outlined the shift in a New England Journal of Medicine policy framework, moving away from broad booster recommendations.[7] The annual flu vaccine advisory meeting, held every year since the late 1960s, was initially canceled in early 2025 before being rescheduled.[3]

Authorization of Fruit-Flavored E-Cigarettes

Action: The FDA authorized fruit-flavored electronic cigarettes for the first time under Makary’s tenure, though Makary reportedly opposed the decision.

Date: May 2026

Evidence: The FDA approved two fruit-flavored vaping products (“Sapphire” and “Gold”) from manufacturer Glas, which uses Bluetooth age-verification technology. Makary reportedly blocked implementation for months and was described by the vaping industry as “very hostile to flavors.” Trump directly reprimanded Makary for frustrating the administration’s campaign promise to support flavored vapes. The authorization, combined with a relaxation of enforcement against e-cigarette makers with pending applications, led to Makary’s forced resignation.[5][11][12][13]

Controversial Drug Rejections

Action: Presided over multiple unexpected rejections of drugs for serious and rare diseases.

Date: 2025–2026

Evidence: Notable rejections included Replimune’s RP1 (advanced melanoma therapy), Capricor Therapeutics’ deramiocel (Duchenne muscular dystrophy cardiomyopathy, summer 2025), and Disc Medicine’s bitopertin (rare disease, initially fast-tracked via CNPV). The Wall Street Journal’s editorial page published at least six op-eds criticizing Makary’s drug rejection decisions. BioSpace reported “predictable volatility” and “unexpected drug rejections” under his leadership.[5]

Reduced Animal Testing and Biosimilar Requirements

Action: Rolled out plans to reduce animal testing requirements and substantially eased biosimilar testing requirements.

Date: 2025

Evidence: Within his first three months, Makary announced a plan to reduce animal testing, scaled up the FDA’s foreign inspections program, and designed a regulatory framework for individualized therapies through a new “plausible mechanism” pathway for rare disease drugs.[10]

Controversies

Pre-Appointment Pandemic Predictions

Makary’s February 2021 prediction that COVID-19 would be “mostly gone by April” proved significantly incorrect. He also claimed in June 2021 that he had been unable to find evidence of a single COVID death in a previously healthy child — a claim contradicted by existing reports of such deaths, though children were much less likely than adults to die from COVID-19.[3][4]

Political Influence on Scientific Decisions

Health policy observers at AgencyIQ/Politico documented a pattern in which labeling changes and product decisions appeared driven by the preferences of Makary and HHS Secretary Kennedy rather than by standard FDA scientific review processes. Examples included the HRT labeling changes, the acetaminophen/autism labeling, and the approval of leucovorin for “autism symptoms.” AgencyIQ wrote that these actions “provide strong evidence that the FDA under Makary is more willing than ever to allow the commissioner and HHS leadership to drive individual product approval and labeling change decisions.”[10]

FDA Staff Departures

Makary’s tenure was marked by an exodus of FDA career staff. CNN reported that “multiple senior CDC officials exited the agency last year and have not been replaced,” and that the FDA “lost its commissioner” leaving yet another vacancy in federal health leadership.[14]

Forced Resignation Over Vaping

Makary’s resignation on May 12, 2026 was precipitated by his reluctance to authorize fruit-flavored e-cigarettes, a campaign promise Trump had made to the tobacco/vaping industry. NBC News reported that “internal pressure to force FDA chief Marty Makary’s resignation was not limited to the vaping dispute, with officials at HHS and the White House growing increasingly unhappy with his policy pushes.”[12][13]

Public Health Impact Assessment

Drug Safety Standards

The shift from requiring two pivotal trials to one for drug approvals represents a fundamental weakening of the evidentiary standard that has protected Americans from unsafe medications since 1998. While individual approvals may still meet safety thresholds, the systemic reduction in requirements creates a higher probability that ineffective or harmful drugs will reach the market over time.

Regulatory Capture Dynamics

The pattern of political figures (the president, HHS Secretary) driving specific product approval and labeling decisions — rather than FDA career scientists following established processes — represents a form of regulatory capture in which political interests override scientific judgment. The vaping authorization, HRT label changes, and acetaminophen labeling decisions all reflected political rather than purely scientific priorities.

Tobacco and Nicotine

The authorization of fruit-flavored e-cigarettes reversed years of FDA policy aimed at preventing youth nicotine addiction. While Makary himself reportedly opposed the decision, the authorization proceeded under his tenure due to direct presidential pressure.

Accelerated Review Risks

While faster drug reviews benefit patients waiting for treatments, the CNPV program’s one-to-two-month review timelines — compared to the standard six-plus months — risk inadequate scrutiny of complex safety and efficacy data, particularly for novel therapeutics.

Truth and Reconciliation Considerations

• Political interference in drug regulation: Documenting the extent to which the White House and HHS Secretary directed specific FDA approval and labeling decisions, overriding established scientific review processes
• Evidentiary standard erosion: Assessing the long-term public health consequences of lowering the default trial requirement from two pivotal trials to one
• Institutional integrity: Examining the departure of career FDA scientists and its impact on the agency’s regulatory capacity
• Tobacco policy: Investigating whether the authorization of flavored e-cigarettes was driven by campaign promises to the tobacco industry rather than public health evidence
• Commissioner independence: Documenting the precedent set when an FDA Commissioner was forced to resign for resisting political pressure on a specific product authorization

Legal Status and Investigations

As of May 2026, Makary is not subject to any known criminal charges or formal investigations. He resigned from the FDA on May 12, 2026.

Congressional oversight hearings examined FDA operations under Makary’s leadership, with particular focus on the CNPV program’s legal authority and the single pivotal trial policy change.[7]

Key Connections

• Robert F. Kennedy Jr. — Political Accountability Profile — Robert F. Kennedy Jr., HHS Secretary and Makary’s direct superior
• Vinay Prasad — FDA Deputy Commissioner, co-authored the single pivotal trial policy and COVID-19 vaccine framework
• Jay Bhattacharya — NIH Director — Jay Bhattacharya, NIH Director, fellow MAHA-aligned appointee
• Kyle Diamantas — FDA Deputy who assumed acting leadership after Makary’s resignation

For Trump Supporters: Questions Worth Considering

• If a drug your doctor prescribes was approved based on one study instead of the traditional two, would you want to know that the safety bar was lowered?
• Makary resigned because Trump pressured him to approve flavored vapes — a product that public health experts say increases youth nicotine addiction. Do you support elected officials overriding their own appointees on scientific safety decisions?
• Makary claimed 50 major reforms at FDA. He was also forced out after 13 months. If the reforms were working, why did the administration push him out over a single product decision?
• The FDA regulates one-fifth of the U.S. economy — the food you eat, the drugs you take, the medical devices your doctor uses. Should those decisions be made by scientists or by campaign donors?
• Makary initially resisted flavored vapes on scientific grounds. What does it say about the administration’s priorities when a commissioner is fired for following the science?

Factual correction requests: If you believe information in this profile is incorrect, please contact factcheck@patriot.university with your name (optional), the specific claim, and any supporting documentation. We review all submissions and correct verified errors promptly.

Sources

1. FDA, “Martin Makary — Commissioner biography,” accessed May 2026. https://www.fda.gov/about-fda/fda-organization/martin-makary
2. Wikipedia, “Marty Makary,” accessed May 2026. https://en.wikipedia.org/wiki/Marty_Makary
3. Time, “What to Know About Marty Makary, Trump’s Pick to Lead the FDA,” 2025. https://time.com/7265012/marty-makary-trump-nominee-fda/
4. News-Medical.net, “Marty Makary, often wrong as pandemic critic, is poised to lead the FDA he railed against,” March 2025. https://www.news-medical.net/news/20250307/Marty-Makary-often-wrong-as-pandemic-critic-is-poised-to-lead-the-FDA-he-railed-against.aspx
5. BioSpace, “FDA’s Makary to resign after Secretary Kennedy signs off,” May 2026. https://www.biospace.com/fda/trump-signs-off-on-plan-to-oust-embattled-fda-commissioner-marty-makary-report
6. Johns Hopkins Hub, “Johns Hopkins surgeon Marty Makary confirmed as FDA commissioner,” March 2025. https://hub.jhu.edu/2025/03/26/marty-makary-confirmed-fda-commissioner/
7. AJMC, “5 Key Regulatory Shifts From Makary’s Era at the FDA,” May 2026. https://www.ajmc.com/view/5-key-regulatory-shifts-from-makary-s-era-at-the-fda
8. FactCheck.org, “RFK Jr.’s Muddled Claims on Drug Approval Speed,” May 2026. https://www.factcheck.org/2026/05/rfk-jr-s-muddled-claims-on-drug-approval-speed/
9. PBS NewsHour, “FDA head on dropping warnings from menopause hormone therapy,” November 2025. https://www.pbs.org/video/one-on-one-1762814196/
10. AgencyIQ by Politico, “Policy and promises: Tracking Makary’s first year running the FDA,” 2026. https://www.agencyiq.com/blog/policy-and-promises-tracking-makarys-first-year-running-the-fda/
11. The Conversation, “Flavored vapes led to a major shake-up at the FDA,” May 2026. https://theconversation.com/flavored-vapes-led-to-a-major-shake-up-at-the-fda-3-health-policy-analysts-explain-the-science-behind-the-controversial-products-283048
12. NBC News, “FDA chief pushed by Trump administration to resign after fight over fruit-flavored vapes,” May 14, 2026. https://www.nbcnews.com/health/health-news/fda-chief-resign-trump-fight-fruit-flavored-vape-rfk-jr-rcna345200
13. Washington Times, “Marty Makary resigns under pressure as head of the FDA,” May 12, 2026. https://www.washingtontimes.com/news/2026/may/12/marty-makary-resigns-pressure-head-fda/
14. CNN, “Trump admin policy shutting US disease researchers out of WHO virus response talks,” May 25, 2026. https://www.cnn.com/2026/05/25/politics/global-virus-response-trump-administration

Cross-References

• Robert F. Kennedy Jr. — Political Accountability Profile — Robert F. Kennedy Jr., HHS Secretary and direct superior
• Jay Bhattacharya — NIH Director — NIH Director and fellow MAHA-aligned appointee
• Dave Weldon — Withdrawn CDC Director Nominee — Withdrawn CDC Director nominee