The official departure of the embattled US Food and Drug Administration (FDA) commissioner Marty Makary on 12 May, following public tension between him and the Trump administration, is the latest high-profile shake-up at the agency since Donald Trump returned as US president last year. The Biotechnology Innovation Organization (BIO), which primarily represents the biotech sector in the US, blamed Makary’s resignation – which was foreshadowed by media reports that the President intended to fire him – on ongoing turmoil at the agency.
‘Makary inherited an FDA in crisis after the DOGE [Department of Government Efficiency] changes, which included the firing of thousands of employees,’ said BIO president John Crowley. ‘These staffing and morale challenges were compounded by constant leadership changes over the past year and questions around shifting FDA standards for drug approvals,’ he added.
Crowley argued that the FDA needs ‘strong, stable and science-driven leadership’ right now, warning that the US is ‘losing the biotech race with China’. He said the agency ‘must be strengthened immediately to ensure that patients continue to benefit and that the United States leads the world in biomedical innovation.’
The Trump administration’s messaging on Makary’s resignation was mixed. In announcing the departure on social media, Trump thanked him for ‘having done a great job at the FDA’ and stated that ‘so much was accomplished under his leadership.’ However, in same-day remarks to the media he said Makary ‘was having some difficulty’. When asked whether he had asked Makary to resign or had fired him, Trump replied: ‘Well, I don’t want to say, but Marty is a great guy.’
Kyle Diamantis, the FDA’s deputy commissioner for food, will temporarily take over Makary’s role.
Media reports suggest that the friction between the White House and Makary was the result of his resistance to fruit-flavoured vapes – the FDA just approved marketing for four such products on 5 May – and because he was seen as delaying an internal review of the abortion drug mifepristone.
Details aside, analysts have described Makary’s tenure as ‘the most damaging period in FDA history,’ stating that about 3500 employees have left the agency since Makary was confirmed in March 2025. During Makary’s tenure, the FDA’s Center for Drugs Evaluation and Research went through four directors and the agency’s Center for Biologics Evaluation and Research (CBER) has had three different directors, following the resignation of long-time leader Peter Marks in April 2025 over insurmountable conflicts with Robert Kennedy, the Secretary of Health and Human Services (HHS), the FDA’s parent department. Among those most recent CDER leaders is Vinay Prasad, who resigned the post under pressure last year and was then rehired just weeks later. He ultimately left the FDA for good in at the end of April and is currently a professor of epidemiology and biostatistics at the University of California, San Francisco.
It is apparent that the White House and HHS ‘have separate agendas’ for the FDA, according to Chemjobber, a Chemistry World contributor and US-based process chemist. He suggests that both are ‘attempting to use the legal and regulatory imprimatur of the FDA for their own purposes […] while neglecting the actual science and process that has made the FDA the standard for approval of medicines globally for the past century.’
Ultimately, Chemjobber says, ‘it is clear that Makary was either finally pushed to face his scruples’ regarding topics like vaping, or he was ‘simply a victim of the power struggles’ between HHS and the White House. He adds: ‘We won’t know which until the behind-the-scenes books are written three years from now.’
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