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Martin Adel Makary (/məˈkæri/) is a British-American surgeon, professor, author, and medical commentator who has served as the 27th commissioner of food and drugs since 2025. He practices surgical oncology and gastrointestinal laparoscopic surgery at Johns Hopkins Hospital, is Mark Ravitch Chair in Gastrointestinal Surgery at Johns Hopkins School of Medicine, and is the chief of Islet Transplant Surgery at Johns Hopkins. Makary completed his surgical residency at Georgetown University and sub-specialty training in surgical oncology and gastrointestinal surgery at Johns Hopkins under John Cameron, later joining Cameron’s faculty practice.

Key Information

Makary has pioneered advanced laparoscopic procedures, including the first laparoscopic Whipple and Frey’s procedures at Johns Hopkins, and led the development of “The Surgery Checklist” in collaboration with the World Health Organization. Makary has held several leadership roles at Johns Hopkins, including Credentials Chair, Director of Quality and Safety for Surgery, clinical lead for the Sibley Innovation Hub, and Executive Director of Improving Wisely. He has published extensively on surgical safety, frailty, teamwork, and hospital quality, and has advocated for public reporting of physician-endorsed quality measures, price transparency, and reform in drug pricing.

Makary is also a bestselling author, with works including Unaccountable, The Price We Pay, Mama Maggie, and Blind Spots, focusing on improving healthcare systems, critical evaluation of medical practices, and personal narratives of humanitarian work. In 2018, he was elected to the National Academy of Medicine.[1] Some of his research and commentary has been controversial, including a widely cited paper claiming medical error is the third leading cause of death in the United States. During the COVID-19 pandemic, Makary supported universal masking early on and vaccines for adults, but opposed broad vaccine mandates, certain school and university restrictions, and boosters for younger populations.[2][3][4][5]

In November 2024, President-Elect Donald Trump announced Makary would be his nominee to head the Food and Drug Administration (FDA) as its commissioner.[6][7] He was confirmed by the United States Senate in March 2025.[8] As FDA commissioner, Makary has prioritized modernizing regulatory processes, launching AI-assisted review tools, and incorporating anecdotal evidence in food safety decisions.

Early life and education

[edit]

Makary was born in Liverpool, England, and moved to Baltimore as a young child. His Egyptian family later moved to Danville, Pennsylvania, when his father took a job as a hematologist at the Geisinger Medical Center. Makary holds undergraduate and medical degrees from Bucknell University, and Thomas Jefferson University. He also completed a Masters of Public Health (M.P.H.) degree, with a concentration in health policy.

Professional career

[edit]

Makary completed a surgical residency at Georgetown University[9][10] in Washington D.C. where he also worked as a writer for The Advisory Board Company. Makary completed sub-specialty surgery training at Johns Hopkins in surgical oncology and gastrointestinal surgery under surgeon John Cameron, before joining Cameron's faculty practice as a partner.[11] In his first few years on the faculty at Johns Hopkins, Makary researched and wrote articles on the prevention of surgical complications.[12] He published on frailty[13] as a medical condition, and on safety and teamwork culture in medicine. Makary is the first author of the original scientific publications describing "The Surgery Checklist".[14] Makary worked with the World Health Organization[15] to develop the official World Health Organization Surgical Checklist.[16]

Makary was named Mark Ravitch Chair in Gastrointestinal Surgery, an endowed chair at the Johns Hopkins University School of Medicine, becoming the youngest endowed chair recipient at the time at the university. Three years later, he was named the Credentials Chair and Director of Quality and Safety for Surgery at Johns Hopkins.[9] In 2020, Makary was named Editor-in-Chief of MedPage Today. He was also appointed chief of the Johns Hopkins Islet Transplant Center, clinical lead for the Johns Hopkins Sibley Innovation Hub, Executive Director of Improving Wisely, a Robert Wood Johnson Foundation project to lower health care costs, and is founder of the Johns Hopkins Center For Surgical Outcomes Research and Clinical Trials.[17]

Makary is a pancreatic surgeon and has pioneered novel surgical procedures. He was awarded the Nobility in Science Award by the National Pancreas Foundation for performing the world's first series of laparoscopic pancreas islet transplant operations.[18] He has traveled with his international team overseas.[19] Makary specializes in advanced laparoscopic surgery and performed the first laparoscopic Whipple surgery at Johns Hopkins and the first laparoscopic Frey's procedure for pancreatitis.[20][21]

Makary's research led to several partnerships, including a grant from the U.S. Department of Health and Human Services Agency for Healthcare Quality and Research, to study obesity treatment,[22] and a grant from the same agency to implement safety programs at 100 U.S. hospitals, a project he collaborated on with Peter Pronovost and the American College of Surgeons. Makary was also the lead author in the original paper introducing a Hospital Survey of Patient Safety Culture.[23]

Makary has called for the public reporting physician-endorsed quality measures by hospitals.[24][25] Makary also advocates for price transparency and has led efforts to ask hospitals to stop suing their low-income patients.[26]

In 2016, Makary and his colleagues exposed loopholes in the Orphan Drug Act accounting for higher drug pricing. His article "The Orphan Drug Act: Restoring the Mission to Rare Diseases",[27] covered by Kaiser Health News,[28] led Senator Chuck Grassley's office to announce an investigation.[29]

Makary, along with Michael Daniel, authored a piece in the British Medical Journal that claimed that medical error is the third leading cause of death in the United States. Multiple critics pointed out the article's poor methodology of how said number is calculated, suggesting the number they presented, just under half a million death per year, is likely an overestimate.[30] Critics have claimed that such numbers give the public the wrong impression regarding the safety and quality of medical care, allowing groups like alternative medicine to further push people from seeking appropriate care.[30]

COVID-19 pandemic

[edit]

During the COVID-19 pandemic, Makary has been a proponent of treating the pandemic as a public health threat,[31] masking,[32] vaccines and early vaccination strategies[33] that prioritized maximum coverage against severe disease similar to the UK vaccination strategy, and protection provided by natural immunity.[34][independent source needed] Makary has also been an outspoken opponent of vaccine mandates, various FDA and CDC policies, and restrictions at colleges and universities.[2]

In February 2020, Makary said on television that the United States needed to take the threat of COVID-19 seriously and that people should stop all non-essential travel.[35] In addition Makary called for a national lockdown to help slow the spread of the virus and enable the healthcare system to respond and reduce morbidity and mortality.[verification needed] In May 2020, Makary advocated for universal masking in an effort to enable businesses and schools to re-open to minimize economic and educational damage across the United States.[36]

In November 2020, Makary was critical of the pace at which the FDA was approving the mRNA vaccines from Pfizer.[37] Makary had taken issue with the speed at which various US government health organizations had taken to evaluate medications or perform COVID-19-based research.[38] In early February 2021, Makary advocated for prioritizing getting as many vaccinated with single doses versus holding vaccines back for second doses.[39]

In a February 2021 op-ed in The Wall Street Journal, Makary predicted that "At the current trajectory", COVID-19 in the United States would "be mostly gone by April" 2021, primarily as a result of naturally acquired immunity, which would result in herd immunity.[40] The article's estimates of herd immunity were criticized for being higher than the best available data supported.[41] Later that year, the Delta and Omicron variants of COVID-19 caused hundreds of thousands of additional deaths in the United States.[3]

Makary considers himself pro-vaccine but has also criticized vaccination mandates for populations other than healthcare workers.[2] Makary recommended a single-dose mRNA vaccine regimen for children 12-17 to minimize the occurrence of myocarditis as a reaction, contrary to the CDC's finding that the risks of infection "far outweigh" those of the two-dose vaccine schedule.[2][42] In December 2021, he appeared on a podcast to argue against vaccine boosters, referring to himself as an "unboosted male" and saying that the SARS-CoV-2 Omicron variant was "nature's vaccine".[43]

On May 20, 2025, FDA Commissioner Makary and CBER director Vinay Prasad published an article in The New England Journal of Medicine announcing that the FDA would limit COVID-19 vaccines to people over 65 or at high risk of serious illness and would require manufacturers to conduct additional large studies to evaluate their benefits for children and healthy younger adults.[44][45]

Nomination to be FDA Commissioner

[edit]

On March 6, 2025, Makary met before the U.S. Senate Committee on Heath, Education, Labor, and Pensions (HELP).[46] His nomination was advanced by the committee to a U.S. Senate vote with a vote of 14 to 9,[47] and subsequently confirmed to the position on March 25, 2025.[8]

On July 10th, Makary posted a statement as FDA commissioner listing several priorities of the FDA under his guidance, announcing the launch of an generative AI tool and integrating it to do "AI-assisted reviews".[48]

On July 14, 2025, Makary appeared on Fox News discussing FDA's new efforts to ban certain food dyes in which he states the FDA is shifting towards using anecdotal evidence as data when regulating food products: "We have a lot of data and it may not necessarily be the traditional 50 year randomized control trial follow up. It's data from families that say their kids have been acting with bad behavior ... and they eliminate the petroleum-based food dyes and the behavior improves. That is data."[49]

Writings

[edit]

Makary is the author of the New York Times Best Selling book Unaccountable, in which he proposes that common sense, physician-led solutions can fix the healthcare system.[50][51] Makary is also the author of Mama Maggie a personal story about his distant relative Magda Gobran, a Nobel Peace Prize nominee working in the garbage slums of Cairo.[52][53][54]

Makary's 2018 book The Price We Pay describes how business leaders can lower their healthcare costs and explores the grass-roots movement to restore medicine to its original mission.[55] Makary is also the editor of the surgery textbook General Surgery Review.[56]

In his 2024 book Blind Spots, Makary urges readers to think critically about today's medical consensuses.[57] In this book, he examined cases where medicine got science wrong, such as the insistence that opioids are not addictive or urging consumers to avoid foods high in fat.[58]

Personal life

[edit]

Makary is a Coptic Christian.[59]

Political views

[edit]

Makary donated to Barack Obama's Presidential Campaign in 2008. He also gave money to Republican House Member Frank Wolf in the mid-2000s.[58]

He has been a public adviser to Paragon Health Institute, a conservative health care think tank.[7]

Awards and recognition

[edit]

Makary is the recipient of numerous research and teaching awards, including the Best Teacher Award for Georgetown Medical School[19] and research awards from the Washington Academy of Surgery and the New England Surgical Society. He has been a visiting professor at over 30 U.S. medical schools and lectures frequently on innovation in health care.[60] Makary was named one of the most influential people in healthcare by HealthLeader magazine in 2013.[61] In 2018, he was elected to the National Academy of Medicine.[62]

References

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Marty Makary

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![Marty Makary being sworn in as FDA Commissioner in 2025](./assets/Marty_Makary%252C_official_portrait_%282025) Martin Adel Makary, MD, MPH, is a British-American , researcher, author, and government official serving as the 27th at the U.S. (FDA) since April 2025. A professor of surgery at School of Medicine and chief of islet transplant surgery, Makary has authored over 300 peer-reviewed publications and multiple New York Times bestselling books critiquing inefficiencies in American healthcare, including opaque pricing and overuse of low-value medical interventions. Makary's career highlights include pioneering the surgical safety checklist to reduce operative errors, leading early studies on patient frailty to improve surgical outcomes, and advancing minimally invasive pancreas and gastrointestinal procedures, earning him election to the in 2018 and the Nobility in Science Award from the National Pancreas Foundation. As FDA Commissioner, confirmed by the in March 2025, he has prioritized evidence-based regulatory reforms, enhanced transparency in agency decision-making, integration of in reviews, and a commitment to "gold-standard science" over expedited approvals lacking rigorous data. His public commentary, often featured in outlets like , has challenged institutional complacency in medicine, advocating for accountability in areas such as diagnostic errors and treatment overutilization, while emphasizing empirical outcomes over consensus-driven practices. Makary's approach reflects a focus on causal mechanisms in healthcare failures, drawing from frontline surgical experience and policy analysis to promote systemic reforms.

Early life and education

Upbringing and family influences

Martin Makary was born in , , to an Egyptian family. As a young child, he relocated with his family to , , where he was raised in a medical household; his father worked as a cancer researcher and hematologist, while his mother contributed to the family's emphasis on healthcare professions. The family later moved to , after his father accepted a position at Geisinger Medical Center. This environment profoundly shaped Makary's early exposure to , with parental involvement in and research fostering an interest in and systemic healthcare issues from a young age. Makary has referenced familial discussions on and , influenced by his father's clinical work, which later informed his own critiques of institutional biases in healthcare delivery. He has also spoken of a sister who pursued , highlighting a household tradition of scientific inquiry into challenges. The immigrant background of his Egyptian parents instilled values of resilience and empirical toward unverified medical dogmas, which Makary credits for his later advocacy against in professional . These formative influences, rooted in direct observation of and family emphasis on data-driven , preceded his academic pursuits and underscored a commitment to reforming opaque healthcare practices.

Academic training and early interests

Makary earned a in biological sciences from before pursuing medical training. He received his M.D. from Thomas Jefferson University's Sidney Kimmel Medical College in 1998. In the same year, he obtained a Master of from the Harvard T.H. Chan School of Public Health, reflecting an early integration of clinical and policy-oriented education. Makary then completed a surgical residency at Georgetown University Hospital. His early interests in stemmed from a family immersed in healthcare; born in , , and raised in , , Makary grew up in a household where his father worked as a cancer researcher and his mother served as a nurse. This environment fostered an appreciation for the physician's capacity to build patient relationships and address community needs, as observed in his father's patient interactions grounded in altruism. During , these foundations evolved into skepticism toward systemic inefficiencies in healthcare delivery, prompting his focus on and eventual emphasis on quality improvement.

Surgical and academic career

Clinical practice and surgical innovations

Makary serves as a professor of at School of Medicine and chief of transplant surgery, where he specializes in minimally invasive pancreatic resections and focused on hepatobiliary and pancreatic conditions. His clinical practice emphasizes laparoscopic techniques for gastrointestinal procedures, particularly those addressing pancreatic tumors and , aiming to reduce recovery times and complications compared to open . He has performed thousands of such operations, contributing to ' high-volume center for complex pancreatic interventions. In 2010, Makary pioneered the laparoscopic Whipple procedure— a complex — at , enabling the resection of pancreatic head tumors through small incisions rather than large abdominal openings, which has since expanded the program's minimally invasive capabilities. He also performed the first laparoscopic Frey procedure for at the institution, combining pancreatic head resection with drainage to alleviate pain and ductal obstruction with reduced invasiveness. These advancements built on his expertise in laparoscopic surgery, allowing for earlier patient mobilization and lower postoperative morbidity in select cases. Makary led innovations in islet cell transplantation, conducting the first-in-the-world series of laparoscopic pancreas islet transplants to restore insulin production in patients with brittle following . As chief of the Center for Islet Transplantation, he integrated techniques during total pancreatectomies, minimizing endocrine deficiencies; this work earned him the National Pancreas Foundation's Nobility in Science Award in recognition of advancing pancreatic surgical outcomes. His procedural developments prioritize evidence-based patient selection, with reported benefits including shorter hospital stays and preserved graft function in peer-reviewed series.

Research on patient safety and healthcare quality

Makary's research on has focused on surgical environments, emphasizing checklists, assessments, and error quantification to mitigate preventable harm. He co-developed the Surgical Safety Checklist, initially adapted from central line insertion protocols at , which includes time-outs for site verification, antibiotic administration, and equipment checks to enhance team communication and reduce complications. This tool informed the World Health Organization's global safe surgery initiative, where Makary served in a leadership role alongside , contributing to its 19-item version tested in a 2009 multicenter study across eight countries that reported a 36% reduction in postoperative complications and 47% drop in mortality. He also led early implementations at , publishing on preoperative briefings that decreased wrong-site surgeries through structured team discussions. In assessing safety culture, Makary co-authored a 2006 study developing and validating a surgery-specific Safety Attitudes Questionnaire (SAQ), administered to 2,769 operating room personnel across 60 U.S. hospitals, which measured factors like climate, stress recognition, and perceptions of management. The SAQ revealed significant inter-hospital variations in safety perceptions, with lower scores correlating to higher rates of adverse events, underscoring the need for cultural interventions over isolated procedural fixes. Complementing this, a 2016 analysis by Makary and Michael Daniel in extrapolated from four large-scale studies to estimate 251,454 annual U.S. deaths from medical errors—equivalent to 9.5% of all deaths—arguing that official CDC rankings undercount due to reliance on ICD codes that fail to capture iatrogenic harm. This estimate, while debated for its extrapolative method, highlighted systemic underreporting and called for mandatory error tracking in vital statistics. Makary's work on healthcare quality integrates safety metrics with evaluations of care appropriateness and outcomes. A 2013 study he co-led found patient satisfaction scores uncorrelated with adherence to evidence-based surgical processes or overall , challenging their use as proxies for quality in pay-for-performance systems. He has advocated for quality measures tied to billing practices, proposing in 2020 five metrics—including lawsuits and denial rates—to incentivize transparent, patient-centered administration rather than opaque pricing. Through national collaboratives, his efforts have promoted data-driven reductions in unwarranted variations, such as overuse of low-value procedures, linking quality to empirical outcomes over subjective metrics.

Academic leadership at Johns Hopkins

Makary joined the School of Medicine faculty following his surgical oncology fellowship there in the early 2000s, establishing a long-term academic presence spanning over two decades. He was appointed as a professor of , specializing in hepatobiliary and gastrointestinal procedures, and later named to an endowed in gastrointestinal surgery before achieving promotion to full professor with tenure. In this capacity, Makary contributed to advancing surgical and training, including pioneering minimally invasive techniques such as the first laparoscopic Whipple and Frey procedures performed at the institution. A key aspect of Makary's leadership involved founding and directing the Johns Hopkins Center for Surgical Trials and Outcomes Research, which focused on empirical evaluation of surgical interventions through randomized trials and outcomes data analysis to improve clinical practices and reduce variability in care. Under his direction, the center emphasized data-driven approaches to surgical quality, including the development of tools like a surgical safety checklist co-created with collaborators, which has been adopted in operating rooms worldwide to mitigate preventable errors. This initiative aligned with broader institutional efforts to prioritize measurable improvements in patient outcomes over anecdotal practices. Makary also served as chief of Islet Transplant Surgery at , overseeing specialized procedures for transplanting insulin-producing cells to treat , where he integrated clinical innovation with rigorous outcome tracking. Complementing his medical school roles, he held a courtesy professorship at the , facilitating interdisciplinary work on and economic aspects of surgical care. These positions underscored his emphasis on integrating first-hand clinical data with administrative oversight to address systemic inefficiencies, such as overuse of procedures, through evidence-based protocols rather than regulatory mandates alone.

Healthcare policy advocacy and writings

Major books and their empirical critiques

Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care (2012) argues that opaque hospital practices conceal incompetence and errors, contributing to preventable . Makary presents from his and national surveys indicating that up to 1 in 4 hospital admissions involves preventable complications, including wrong-site surgeries occurring in 1 per 112,000 procedures and medication errors in 1.5 million instances annually. He supports calls for transparency with from voluntary reporting systems showing improved in institutions adopting checklists, reducing surgical mortality by 47% in one randomized trial he co-authored. Critiques of the book's empirical foundation contend it oversimplifies complex safety metrics, such as overemphasizing surveys despite mixed evidence of their causal impact on outcomes; one analysis notes that while surveys correlate with lower error rates, causation remains unproven in large-scale , potentially inflating perceived efficacy of transparency alone without systemic overhauls. Nonetheless, core claims align with broader datasets, like the Agency for Healthcare Research and Quality's estimates of 700,000 annual adverse events, underscoring underreporting biases in self-assessed . The Price We Pay: What Broke American Health Care—and How to Fix It (2019) dissects pricing distortions, documenting interstate variations where identical procedures like hip replacements cost $17,000 in one facility versus $120,000 elsewhere, uncorrelated with quality metrics per analyses of commercial claims data covering millions of patients. Makary cites administrative bloat absorbing 25-31% of U.S. health spending—double peer nations—via examples of pharmacy benefit managers inflating drug costs through rebates, and hospital markups averaging 340% on supplies, backed by government audits revealing $60 billion in annual waste from overtesting. He advocates price transparency, pointing to early state mandates reducing costs by 10-20% in affected markets. Empirical pushback questions the universality of no price-quality , as some longitudinal studies in high-deductible plans show modest outcome improvements with higher spending on coordinated care, though Makary counters with procedure-specific data from Medicare claims lacking such links. Critics from payer perspectives argue transparency alone fails without rate regulation, citing post-ACA analyses where disclosure rules yielded negligible savings due to negotiated contracts overriding list prices, but Makary's examples of cash-pay innovations achieving 50-80% discounts validate targeted reforms' potential. Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health (2024) challenges entrenched dogmas, marshaling meta-analyses showing low-fat dietary guidelines contributed to rises via overemphasis, with cohort studies like Nurses' Health linking processed carbs to 20-30% higher cardiovascular risk versus low-carb alternatives. On opioids, it references CDC data revisions admitting overestimation of overdose deaths tied to prescription patterns, while critiquing protocols based on flawed trials; Makary cites randomized evidence from LEAP study extensions indicating early exposure halves allergy rates, contra prior avoidance advice. For longevity, he highlights microbiome research from fecal transplant trials improving outcomes in 70% of recurrent infection cases, ignored by guidelines. Critiques accuse selective evidence use, such as overstating benefits for menopause—claiming 50% heart attack reductions—against follow-ups showing null or adverse effects in non-initiators under age 60, potentially misleading on absolute risks. On nutrition, contrarian emphasis on seed oils risks dismissing observational confounders in diets, per systematic reviews finding weak for harms amid stronger tobacco-alcohol links. Yet, the book's aggregation of shifts, like deprescribing trials reducing harms by 15-25%, underscores establishment inertia, with peer-review biases documented in retracted consensus papers. Sources critiquing Makary often stem from academic networks defending incumbents, potentially underweighting replicable outliers in evolving fields.

Public commentary on pricing transparency and reform

Makary has critiqued the opacity of healthcare pricing as a core driver of inefficiency and exploitation in the U.S. system, asserting that patients are often billed exorbitant, non-negotiated rates without prior knowledge, leading to widespread financial distress. In his 2019 book The Price We Pay: What Broke American Health Care—and How to Fix It, he details how hospitals' "" lists feature arbitrarily inflated prices—sometimes marked up thousands of percent over costs—that are rarely shown to patients until after services are rendered, enabling surprise bills that contribute to medical bankruptcies. He attributes this lack of transparency to a breakdown in market discipline, where providers face no competitive pressure to justify or lower rates, resulting in a 2014 Gallup poll showing only 23% of Americans expressing high confidence in the healthcare system's trustworthiness. He has condemned specific abusive practices, such as hospitals pursuing lawsuits against patients and wage garnishments for unpaid bills, describing these as antithetical to medicine's patient-centered heritage and emblematic of a profit-driven distortion. Makary argues that such tactics, combined with undisclosed fees for routine procedures, exacerbate distrust and stifle innovation, as evidenced by cases where patients receive itemized bills revealing charges like $50 for a single aspirin tablet. To address this, he endorses mandatory upfront price disclosure for hospitals and insurers, viewing the Trump administration rule requiring public posting of standard charges as a vital disruption of legacy pricing opacity that empowers consumers to shop and negotiate. In public forums, Makary has promoted market-oriented reforms like reference-based , where employers anchor reimbursements to Medicare rates or medians, forcing providers to compete on value rather than secrecy; he cites early adopters achieving 20-50% cost reductions without compromising care quality. He maintains that transparency alone could halve administrative waste—estimated at $265 billion annually—by aligning incentives with actual costs, drawing on empirical data from states like , where mandated disclosures correlated with price declines for procedures like joint replacements. Makary warns that without such reforms, middlemen like pharmacy benefit managers will perpetuate gouging, as seen in opaque chains where list prices bear little relation to negotiated outcomes.

Influence on policy debates pre-COVID

Makary's advocacy for healthcare price transparency gained prominence in the years leading up to 2019, driven by his empirical observations of opaque pricing practices that distorted market incentives and burdened patients with unpredictable costs. In his 2012 book Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care, he documented systemic failures in hospital accountability, including unreported medical errors and inflated charges unrelated to quality, arguing that public disclosure of outcomes and prices would foster competition and reduce waste. This work influenced broader discussions on patient safety metrics, contributing to calls for mandatory reporting of adverse events, though implementation lagged due to industry resistance. By 2019, Makary's focus shifted to pricing reform amid rising evidence of surprise billing and administrative bloat, as detailed in his book The Price We Pay: What Broke American —and How to Fix It, published that July, which highlighted how secrecy in negotiated rates between hospitals and insurers enabled price gouging, with some procedures costing patients tens of thousands more across facilities for identical services. He collaborated with the Trump administration on the Department of Health and Human Services' June 2019 rule mandating hospitals to post standard charges online by January 1, 2021, a aimed at empowering consumers with to shop for care and negotiate better terms. Makary testified and wrote op-eds emphasizing that transparency would expose overutilization—such as unnecessary MRIs or stents driven by incentives—potentially saving billions annually, though critics from hospital associations contended it oversimplified complex reimbursements. His pre-COVID efforts extended to critiquing regulatory barriers that stifled , including excessive prior authorizations and certificate-of-need laws that protected incumbents from , as evidenced by state-level showing higher costs in restricted markets. Makary's -driven arguments, often citing Medicare claims analyses revealing 30-50% price variations for common procedures, pressured policymakers toward incremental reforms like the 2019 transparency mandates, setting precedents for later surprise billing negotiations while highlighting academia's reluctance to challenge entrenched interests.

Stance on COVID-19 pandemic

Critiques of lockdowns, masks, and school closures

Makary initially endorsed short-term lockdowns in early 2020 to flatten the curve and allow healthcare system preparation, but by mid-2020 advocated shifting to targeted protections for vulnerable groups rather than blanket restrictions, citing emerging data on age-stratified risks where the virus posed minimal threat to most healthy individuals under 50. He later characterized prolonged nationwide lockdowns as causing disproportionate collateral damage, including delayed cancer screenings—estimating over 100,000 excess U.S. cancer deaths from missed diagnoses in 2020—and widespread mental health deterioration, arguing these harms exceeded direct COVID mortality benefits for low-risk populations. In critiquing school closures, Makary emphasized their empirical fallout on , including a UNESCO report documenting global learning losses equivalent to 0.5 years of schooling and U.S. data from the Centers for Disease Control and Prevention (CDC) showing doubled adolescent attempts by mid-2020 amid isolation. He faulted CDC guidance in February for prioritizing low-probability transmission risks over these documented harms, noting children under 18 accounted for just 0.08% of U.S. COVID deaths by then and transmitted inefficiently due to lower viral loads. Prolonged closures, he argued, exacerbated educational inequities, with low-income students facing steeper declines in math and reading proficiency per scores post-2020. Makary opposed universal mask mandates, particularly for children, co-authoring a 2021 Wall Street Journal piece asserting that forcing on low-risk youth sacrificed developmental milestones—like facial expression recognition essential for social-emotional growth—for negligible gains, as randomized trials such as Denmark's 2020 study showed no significant infection reduction from community masking. He highlighted ' interference with efficacy, citing a 2021 study in JAMA Pediatrics where masked educators hindered consonant identification in toddlers, and argued children were "very inefficient transmitters" given their physiology and behaviors. These positions drew from observational data, such as Israel's 2021 experience where masking schoolchildren yielded no measurable drop in case rates among that cohort.

Positions on vaccines, boosters, and mandates

Makary has consistently supported the development and use of vaccines, emphasizing their value for vulnerable populations such as the elderly and immunocompromised, while cautioning against overly broad recommendations that lack robust evidence for low-risk groups. In a May 2025 New England Journal of Medicine article co-authored with FDA colleague , he advocated for an evidence-based framework prioritizing randomized controlled trials for future approvals and aligning U.S. policy more closely with countries like the , which limit boosters to high-risk individuals rather than recommending them annually for all adults. As FDA Commissioner, Makary defended policy shifts in May 2025 that removed vaccines from routine recommendations for healthy children under 12 and healthy pregnant women, arguing these changes reflect hindsight on limited benefits in low-risk cohorts and aim to rebuild eroded by prior universal pushes. Regarding boosters, Makary has expressed skepticism toward indefinite or universal dosing, stating in a September 2025 Wall Street Journal that the emergency phase has ended and perpetual boosters lack justification, particularly for healthy populations where natural decline in efficacy over time does not warrant repeated shots absent new variant threats. He highlighted data showing minimal additional protection from boosters in previously vaccinated or recovered individuals, contributing to his May 2025 FDA framework that questions annual updates without stronger trial evidence and notes broad prior recommendations have fueled across other immunizations. In June 2025 testimony, Makary criticized the CDC's Advisory Committee on Immunization Practices as operating like a "kangaroo court" for endorsing boosters without sufficient scrutiny, advocating instead for individualized assessments over blanket federal guidance. Makary has opposed broad mandates, particularly those disregarding prior status, arguing they ignore empirical evidence on immunity and impose undue coercion. In May 2023 congressional , he cited over 200 studies demonstrating natural immunity's equivalence or superiority to vaccine-induced against severe , asserting mandates led to unnecessary job losses for recovered healthcare workers and wasted resources on low-risk individuals. He supported mandates limited to unrecovered healthcare personnel in high-exposure roles but rejected population-wide requirements, as seen in his January 2022 critique of policies that penalized naturally immune workers despite data from sources like a Lancet meta-analysis showing durable post-. Makary's stance aligns with a risk-stratified approach, informed by seroprevalence studies indicating robust durability from alone.

Empirical predictions and post-hoc validations

In February 2021, Makary predicted in a Wall Street Journal op-ed that the would achieve against by April, citing a combination of prior infections (estimated at 50-80 million Americans by then, based on wastewater and seroprevalence data) and accelerating vaccinations, which would reduce transmission dramatically before widespread Delta variant emergence. This forecast contrasted with National Institute of Allergy and Infectious Diseases Director Anthony Fauci's projections of not until later in 2021 or beyond, due to Fauci's higher estimates of required immunity thresholds (70-85%) and lower prior infection rates. Post-hoc analysis partially validated Makary's timeline: by mid-2021, daily cases had fallen over 90% from winter peaks, driven by infection-acquired immunity in low-vaccination areas and hybrid immunity, though delayed full population-level suppression until vaccines scaled; critics, including outlets citing CDC data, argued the prediction overstated short-term control, as hospitalizations persisted into summer among unvaccinated groups. Makary critiqued school mask mandates in 2021, arguing they lacked randomized trial evidence for efficacy in children and posed developmental risks, such as impaired , emotional recognition, and increased bacterial infections, based on pediatric studies showing alter and cause discomfort distracting from learning. He co-authored a Journal of the viewpoint emphasizing the absence of high-quality data supporting for low-risk pediatric populations. Subsequent observational data aligned with these concerns: a CDC-funded study across 613 districts found no statistically significant difference in student incidence between mask-mandated and non-mandated schools during 2021-2022, while meta-analyses reported non-pharmaceutical interventions like had limited impact on overall transmission in educational settings compared to and ventilation. Learning losses from associated closures, which Makary opposed as disproportionate to viral risks for children (fatality rate under 0.01% per CDC data), were confirmed in longitudinal assessments showing persistent deficits in math and reading proficiency equivalent to 0.5-1 year of schooling. Regarding boosters and mandates, Makary in 2022 questioned the scientific basis for universal booster recommendations, predicting they would yield diminishing returns for healthy populations due to waning against infection (as seen in Israeli data showing 40% protection after six months) and risk eroding in programs. He highlighted early data indicating boosters primarily reduced severe outcomes in high-risk groups rather than transmission. Validation emerged in uptake trends: by 2023-2024, booster acceptance dropped to under 20% nationally and 15% among healthcare workers, per CDC , correlating with real-world studies (e.g., reports) demonstrating boosters' protection against hospitalization fading to 30-50% within months against subvariants. Makary's pre-mandate warnings on overreach were echoed in 2024 analyses linking coercive policies to spillover, though mainstream public health bodies maintained mandates' role in initial uptake; he later influenced FDA's 2025 framework restricting recommendations to those over 65 or high-risk, citing insufficient net benefit data for broader use.

FDA Commissioner nomination and tenure

Nomination process and Senate confirmation

President Donald Trump nominated Martin Makary to be Commissioner of Food and Drugs on January 20, 2025. The nomination was referred to the Senate Committee on Health, Education, Labor, and Pensions (HELP). Makary's confirmation hearing before the Senate HELP Committee occurred on March 6, 2025, where he addressed topics including drug approval processes, vaccine policies, ethical considerations in agency operations, drug shortages, food safety standards, and potential reforms to FDA practices. On March 13, 2025, the committee advanced the nomination on a 14-9 party-line vote, with two Democrats—Sens. John Hickenlooper (CO) and Maggie Hassan (NH)—joining Republicans in support. The full confirmed Makary on March 25, 2025, by a 56-44 vote, largely along party lines, with the bipartisan support from the two HELP Committee Democrats carrying over to the floor. Makary was subsequently sworn in as the 27th FDA Commissioner on April 1, 2025.

Implemented reforms and modernization efforts

Upon assuming the role of on April 1, 2025, Marty Makary prioritized reforms aimed at enhancing scientific rigor, reducing regulatory burdens, and improving . One early action was the issuance of a policy directive on , 2025, limiting employees of companies regulated by the FDA—such as pharmaceutical firms—from serving as official voting members on advisory committees, where statutorily permissible, to minimize perceived industry influence and bolster in independent evaluations. Exceptions were permitted for statutory requirements like presentations or rare cases of unique expertise, with strict reviews, while emphasizing inclusion of patients and caregivers. In food safety, Makary oversaw the initiation of a phase-out of petroleum-based synthetic dyes from the U.S. food supply, announced on April 22, 2025, targeting six such additives (Blue 1, Blue 2, Green 3, Red 3, Red 40, and Yellow 5 and 6) linked to behavioral issues in children, with a transition timeline extending to the end of 2026 through industry collaboration and regulatory revocation processes. The FDA approved three alternatives and accelerated reviews for others, alongside launching a review of concerning chemicals like BHT, BHA, and , and establishing a Regulatory Science Program in partnership with the to advance evidence-based standards. Makary announced a shift in U.S. dietary guidelines from low-fat recommendations to prioritizing whole, nutrient-dense foods like meat and protein while de-emphasizing ultra-processed carbohydrates, with reductions in added sugars and ultra-processed products in areas such as school lunches. He stated that data from a study showing higher heart attack rates in low-fat diet groups had been suppressed for 16 years before trickling out in the medical literature, and that past guidance had misled the public against dietary fats, leading to increased sugar and ultra-processed carbohydrate consumption under guidelines influenced by political pressure and industry lobbies including the sugar industry. This change aligned with the Dietary Guidelines for Americans, 2025–2030, released on January 7, 2026, marking a reversal toward real food nutrition policy. Modernization efforts included the deployment of Elsa, an agency-wide generative AI tool launched on June 2, 2025, to streamline employee tasks such as data summarization and review processes, following a successful pilot of AI-assisted scientific reviews completed on May 8, 2025, aimed at expediting and evaluations without compromising accuracy. Complementary initiatives encompassed consolidating adverse event databases for better , publishing a roadmap with pilots to reduce reliance on in product development, and introducing the ’s National Priority Voucher program to shorten certain review timelines to 1-2 months for high-priority therapies. Transparency measures involved launching FDA Direct, a public communication platform, and committing to routine publication of decision letters for rejected applications. In diagnostics and treatments, the FDA under Makary cleared the first blood-based test for Alzheimer’s disease and began deregulating laboratory-developed tests (LDTs) to foster . Additionally, revised labeling and frameworks for vaccines incorporated updated safety data, while enforcement actions seized $34 million in illegal e-cigarettes in coordination with U.S. Customs. These steps, outlined in Makary's July 10, 2025, 100-day statement, emphasized empirical prioritization over bureaucratic expansion.

Ongoing controversies and defenses

Makary's tenure as FDA Commissioner has faced criticism over significant staff turnover and declining employee morale. Since his confirmation on March 25, 2025, reports indicate a steady exodus of experienced personnel, including senior staff involved in factory inspections and reviews, amid broader layoffs under the Trump administration. Current and former FDA employees have attributed this to anxiety over new directions, potentially compromising the agency's operational capacity. In response, Makary has publicly asserted the agency's independence from external influences, stated no major reorganization is planned, and committed to reviewing recent firings to stabilize operations. Critics have also questioned Makary's approach to advisory committees and expert panels for drug approvals. The FDA under his leadership has proposed reducing reliance on these bodies for certain reviews, aiming to expedite processes, which contrasts with Makary's pre-tenure advocacy for more committee input on vaccines in 2022. Opponents, including researchers and former officials, argue this risks bypassing independent expertise and could prioritize speed over safety. Additionally, newly formed ad-hoc panels have drawn scrutiny for including members with financial conflicts of interest and views deemed fringe, such as downplaying risks of . Makary has defended these shifts by emphasizing transparency measures, like publishing full response letters to drug sponsors, and openness to innovative therapies for chronic diseases, while maintaining gold-standard scientific rigor. Lingering controversies from Makary's pre-FDA public commentary, particularly on , have resurfaced, with detractors accusing him of overstating vaccine side effects and underestimating viral risks, potentially eroding public trust. During his March 6, 2025, confirmation hearing, lawmakers pressed him on policy continuity and staff cuts, highlighting fears of politicized . Makary countered by pledging evidence-based reforms, including enhanced clinical trial flexibility, AI integration for efficiency, and investigations into food additives linked to , framing these as responses to an "epidemic" of chronic conditions requiring adaptive regulation. Despite such pushback, his bipartisan confirmation and focus on affordability in expedited approvals—such as tying vouchers to drug pricing—have garnered support from industry stakeholders seeking streamlined processes.

Broader political positions

Views on regulatory bureaucracy and overreach

Makary has argued that excessive at agencies like the FDA stifles medical innovation by imposing prolonged review timelines and outdated procedural layers that delay access to therapies, particularly for rare diseases and treatments. In a November 2024 interview, he described the FDA as "too , taking too much time," emphasizing that such delays prevent patients from benefiting from evidence-based advancements while competitors in approve similar drugs faster. This perspective aligns with his broader critique of federal health agencies' acceptance of inertial processes, as outlined in a 2021 opinion where he called for new leadership to challenge entrenched norms that prioritize caution over timely evidence assessment. He has specifically targeted internal redundancies and legacy systems, asserting in June 2025 that these elements have extended cycles by years, contributing to America's lag in biotech approvals compared to global peers. Makary attributes part of this overreach to regulatory failures enabling misleading pharmaceutical , which surged after a 1997 FDA policy relaxation on disclosures; he has advocated for stricter enforcement to correct "decades of regulatory failure" without expanding the agency's footprint. In congressional testimonies and writings, he has highlighted cases like gene therapies, where bureaucratic hurdles—such as repeated advisory committee reviews—have overridden preliminary efficacy data, arguing that such processes reflect risk-averse overregulation rather than rigorous science. Makary's views extend to broader overreach in advisory structures, where he has criticized the influence of industry-tied experts and politicized panels, proposing limits on conflicted participants to restore focus on empirical outcomes over procedural theater. He maintains that trimming redundancies, as pursued through staff adjustments targeting duplicative roles, enhances without undermining , countering claims of morale erosion by framing cuts as essential to eliminating bloat accrued over decades. These positions draw from first-hand observations in surgical innovation and , where he posits that causal bottlenecks in approval pathways—verifiable via comparative international timelines—outweigh hypothetical risks of accelerated reviews backed by post-market surveillance.

Alignment with market-oriented health policies

Makary has long advocated for greater price transparency in healthcare as a mechanism to foster and empower consumers, arguing that opaque pricing enables price gouging by hospitals and middlemen. In his 2019 book The Price We Pay, he details how hospitals charge vastly different prices for identical procedures unrelated to quality, citing examples such as a single hospital's charges for the same varying by factors of ten or more, which he attributes to a lack of market discipline due to billing secrecy. He has supported federal rules requiring hospitals to disclose standard charges, noting in interviews that such transparency allows patients and employers to shop for lower-cost providers, as evidenced by outpatient surgical centers that increased business volumes after publicizing prices. He criticizes healthcare consolidations and monopolistic practices that stifle and inflate costs, particularly through Medicare's disparities that incentivize acquisitions of independent physicians and centers. Makary argues that Medicare's higher reimbursements for hospital-based services—up to twice as much for the same procedure—create a "" where hospitals buy competitors to capture these premiums, reducing options for patients and driving national spending higher without quality gains. He has endorsed site-neutral payments to eliminate these distortions, positing that equalizing reimbursements across settings would promote efficiency and curb the merger wave that has concentrated 90% of metropolitan markets in fewer hands. As FDA Commissioner, Makary has pursued to reduce bureaucratic hurdles, lower costs, and accelerate , aligning with market principles by prioritizing provider and patient empowerment over administrative mandates. In May 2025, he co-led a on a deregulatory plan aimed at streamlining approvals and cutting , stating it would "restore to regulation" by identifying rules that hinder timely access to treatments. This builds on his prior calls to address middlemen like pharmacy benefit managers, whose opaque rebates he views as anti-competitive barriers that obscure true drug prices and limit .

Responses to mainstream media narratives

Makary has consistently challenged portrayals of risks, particularly the emphasis on universal vulnerability and the dismissal of age-stratified data. In May 2020, he appeared on platforms to argue that media-driven fear overlooked empirical evidence of low infection fatality rates among children and young adults, citing early seroprevalence studies indicating thresholds were closer than reported and that prolonged school closures would cause more harm than benefit through lost education and social development. He contrasted this with narratives in outlets like , which amplified worst-case projections from models like Imperial College London's, later critiqued for overestimating deaths by factors of 10-100 in multiple jurisdictions when compared to observed outcomes. Regarding vaccine policies, Makary rebutted media claims framing opposition to mandates as anti-vaccine sentiment, asserting in 2023 congressional testimony and subsequent interviews that while prevent severe outcomes in high-risk groups, boosters for healthy lacked robust randomized data justifying universal rollout, especially amid emerging of waning against . He highlighted Israeli Ministry of Health data from 2021 showing natural immunity conferred stronger, longer-lasting protection against Delta variant hospitalization than two-dose (13-fold higher risk reduction), a finding initially downplayed or omitted in U.S. media coverage favoring vaccination-only narratives despite peer-reviewed publication. During his 2025 FDA confirmation hearings, responding to queries echoing media skepticism, Makary affirmed "vaccines save lives" but stressed -based application over , countering portrayals of him as a by referencing post-hoc validations like reduced risks post-reopening. Makary has also addressed media suppression of dissenting views, noting in a March 2024 interview that much censored content—such as the Great Barrington Declaration's focused protection strategy—proved prescient, with subsequent studies confirming minimal COVID mortality in low-risk populations and excess non-COVID deaths from lockdowns exceeding direct viral impacts in some analyses. On emerging issues like acetaminophen and autism, following 2025 FDA announcements citing observational data from over 2,000 studies showing associations (e.g., 20-30% increased odds with prenatal exposure), Makary responded to media dismissals by invoking the , arguing parental choice amid unresolved causation debates rather than outright rejection, as critiqued in fact-checks from outlets like that prioritized null findings from smaller cohorts. This approach underscores his broader critique of institutional media's tendency to align with orthodoxy, often sidelining first-line clinical data in favor of consensus-driven reporting.

Personal life

Family background and personal relationships

Martin Makary was born in , , to parents of Egyptian Coptic Christian heritage who immigrated to the during his early childhood. The family first settled in Baltimore, Maryland, before relocating to , where his father, Adel Makary, took a position as a hematologist at Geisinger Medical Center. Makary's father had earlier worked as a serving a poor community in , continuing a familial emphasis on healthcare access, as Makary's grandfather was also a . Makary remains close to his family, including his mother, whom he has described as sacrificial, and his father, a career role model in medicine. He has a brother and a sister. Makary is married to Jessica Beames, who has held professional roles in finance, most recently at BOK Financial.

Philanthropy and non-professional activities

Makary chairs the medical advisory board of African Mission Healthcare Foundation, a non-profit organization that partners with indigenous churches in to deliver surgical care, train local providers, and build healthcare infrastructure. In this volunteer capacity, he has supported efforts to enhance oxygen access and surgical capabilities amid challenges like the , leveraging his surgical expertise to guide mission-based initiatives without direct compensation. The foundation received its largest private donation in , underscoring the impact of such advisory roles in scaling Christian medical missions. Beyond medical missions, Makary serves on the Board of Advisors for the Foundation for Research on Equal Opportunity (FREOPP), a non-partisan advocating reforms. There, he contributes to analyses of responses and healthcare , distinct from his academic and government duties. These engagements reflect his commitment to equity and policy improvement outside professional remuneration, though specific personal donations or endowments remain undocumented in public records.

Awards and recognition

Surgical and medical honors

Makary was awarded the Nobility in Science Award by the National Pancreas Foundation for his pioneering development of laparoscopic pancreas islet transplant operations, marking a significant advancement in minimally invasive surgical techniques for diabetes treatment. In 2018, Makary was elected to the National Academy of Medicine, recognizing his foundational contributions to patient safety, including co-developing the surgical safety checklist adopted globally to reduce operative errors and leading early research on surgical frailty assessment and minimally invasive pancreatic procedures. Makary has held leadership positions in the World Health Organization's Patient Safety Program, contributing to international standards for reducing medical errors in surgical settings. His clinical roles, including chief of Islet Transplant Surgery and endowed chair in gastrointestinal surgery at , reflect institutional acknowledgment of his expertise in hepatobiliary and pancreatic oncology.

Policy and literary accolades

Makary's literary works on health policy have garnered significant recognition, including New York Times bestseller status for Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care (2012) and The Price We Pay: What Broke American Health Care—and How to Fix It (2019). The Price We Pay, which critiques opaque pricing and advocates for market-driven reforms in healthcare, received the 2020 Business Book of the Year Award from the Association of Business Journalists. His other policy-focused books, such as Blind Spots: Why We Ignore Dangers That Stare Us in the Face (2024), address cognitive biases in public health decision-making but have not been noted for formal literary awards. In policy circles, Makary's expertise has been acknowledged through high-level appointments reflecting his advocacy for evidence-based regulation and reduced bureaucratic overreach. On November 22, 2024, President-elect Donald J. Trump announced Makary's nomination as , praising his work on transparency and . The U.S. confirmed him on March 25, 2025, leading to his swearing-in as the 27th on April 1, 2025, a role that positions him to influence on drug approvals, , and medical innovation. This appointment underscores recognition of his prior policy contributions, including testimonies before on healthcare pricing and responses, though no standalone policy-specific awards beyond his literary honors are documented.

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  117. https://www.medpagetoday.com/publichealthpolicy/fdageneral/114494
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  120. https://www.copticsolidarity.org/2024/11/23/dr-martin-makary-chosen-to-head-the-f-d-a/
  121. https://freopp.org/team/marty-makary/
  122. https://www.help.senate.gov/download/makary-opening-statementpdf
  123. https://africanmissionhealthcare.org/amhs-transforming-healthcare-in-africa-campaign/
  124. https://africanmissionhealthcare.org/02-africa-the-gift-of-oxygen/
  125. https://www.jpost.com/international/christian-medical-missions-receive-largest-private-gift-ever-from-jews-680274
  126. https://springconference.nic.org/speakers/martin-makary-m-d-m-p-h-f-a-c-s/
  127. https://www.goodreads.com/author/show/5786795.Marty_Makary
  128. https://www.bloomsbury.com/us/price-we-pay-9781635575910/
  129. https://www.presidency.ucsb.edu/documents/statement-president-elect-donald-j-trump-announcing-the-nomination-marty-makary
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