Marty Makary

Makary launched a programme allowing substantially accelerated reviews of medicines considered aligned with 'national priorities'. Employees, lawyers and external experts feared that selection by political leadership and review periods of one to two months could undermine reviewers' independence or politicise drug approvals.

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Bloomberg reported, citing people familiar with the matter, that Makary had requested a delay to a mifepristone safety review until after the midterm elections, although HHS and the FDA publicly claimed to be conducting a review. The allegation prompted accusations of political calculation on an exceptionally sensitive issue.

Makary resigned as FDA commissioner on 12 May 2026 after approximately thirteen months. His departure followed months of tensions with administration officials, industry representatives, anti-abortion activists and vaping interests, together with a succession of senior departures. Sources notably linked his exit to a dispute over approval of flavoured e-cigarettes.

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Makary co-signed with Jay Bhattacharya and Mehmet Oz a memorandum recommending that the CDC overhaul the childhood vaccination schedule. The change reduced from 18 to 11 the number of diseases for which immunisation was universally recommended and moved vaccines against hepatitis A and B, rotavirus, influenza and meningococcal disease, among others, into more restricted categories. The American Academy of Pediatrics and other organisations denounced the absence of the usual ACIP process and brought legal proceedings to block the reform.

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Makary supported a more restrictive FDA approach to COVID vaccines for young and healthy people. When HHS announced the withdrawal of certain recommendations for healthy children and pregnant women without awaiting the usual ACIP process, specialists denounced a departure from established procedure and regulatory science. Makary described ACIP as a 'kangaroo court' that 'rubber stamp' vaccines.

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The FDA initiated a labelling change indicating a possible association between acetaminophen use during pregnancy and neurodevelopmental disorders. Makary publicly claimed that an academic official had referred to a 'causal relationship', whereas the scientific review cited indicated only an association compatible with possible causation and the need for further research. Numerous medical societies stressed that a causal link had not been established.

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Under Makary, the FDA began removing certain broad boxed warnings on menopausal hormone treatments, a decision supported in some respects by many specialists. The controversy primarily concerned communications by Makary and Robert F. Kennedy Jr., who presented hormone therapy as potentially delivering very substantial cardiovascular, cognitive and longevity benefits, citing estimates considered selective.

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Early in his tenure, the FDA lost approximately 3,500 employees, nearly one-fifth of its workforce, as part of broader administration job cuts. Employees interviewed described very low morale, loss of expertise, increased political involvement in certain decisions and distrust of management announcements. Further departures of senior executives deepened the governance crisis.

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In opinion pieces and media appearances, Makary argued that post-infection immunity was sometimes undervalued, criticised vaccine mandates and made categorical claims about the absence of benefits from masks or school closures for children and certain vaccine-related risks. Scientific reviews of his statements concluded that they mixed accurate information with misleading, insufficiently substantiated or inaccurate claims.

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In a Wall Street Journal opinion piece, Makary predicted that the United States would reach herd immunity against COVID-19 by April 2021, relying notably on a very high estimate of the proportion of the population already infected. Epidemiologists considered that the assumptions about undetected infections, fatality rates and immune protection were insufficiently supported; the prediction did not materialise as announced.

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Makary and Michael Daniel published a BMJ analysis estimating that approximately 250,000 deaths annually in the United States could be associated with medical errors, making them the third leading cause of death. The estimate received extensive coverage but was criticised by patient safety specialists for extrapolating from several heterogeneous studies and relying on assumptions considered too strong concerning the preventability of deaths.

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