Is Makary on the way out, and who might replace him?

Marty Makary's position as FDA Commissioner is in jeopardy and he could soon be ousted, according to media reports, in what would be yet another example of the chaos in the Trump administration's health leadership.

The Wall Street Journal has suggested that the White House is preparing to fire Makary, citing sources familiar with the matter, one of whom said President Trump has already signed off on the decision. However, the President told reporters on Friday that there was no plan to change the FDA leadership when asked about the matter.

The uncertainty has led to speculation about who could step into Makary's shoes, but it is likely that the current Deputy Commissioner of the agency's food division, Kyle Diamantas, would serve as acting Commissioner while a new nomination is sought.

Names being ground out at the rumour mill include former FDA Commissioner Stephen Hahn, who was appointed during Trump's first term and led the agency from 2019 to 2021, and former Acting Commissioner Brett Giroir, who led the agency on an interim basis before Hahn took over.

Makary's time at the FDA has coincided with a major upheaval at the agency, with sweeping layoffs stripping the agency of experienced staff and the replacement of senior staffers with divisive appointments that have led to plunging staff morale and allegations of politicisation of regulatory and scientific decisions.

There has been a lot of debate and controversy about the direction the FDA has taken under Makary and HHS Secretary Robert F Kennedy Jr.

That includes allegations of inconsistency in drug reviews, the ultra-quick appraisals of some new products under the Commissioner's National Priority Voucher (CNPV) programme, the move toward relying on one, rather than two, pivotal trials to support approvals, vaccine rollbacks, and a failure to release public results of investigations into the safety of COVID-19 and shingles vaccines that some claim do not support Kennedy's anti-vaccine agenda.

It's possible that if Makary does go, the tipping point for Trump could have been far more banal, stemming from a disagreement between Makary and the President over the approvability of fruit-flavoured vapes, which are seen as encouraging young people to take up vaping.

The FDA Commissioner initially blocked their approval, but in an about face last week gave them the green light, reportedly giving in to Trump's wish to score a win with younger voters ahead of the midterms.

The FDA's chaotic leadership is also apparent in the changes to its two main drug regulatory divisions, CDER and CBER – which have seen multiple changes under Kennedy and Makary and are both led at the moment by acting directors – while other agencies, including the CDC and NIH, have also seen a rapid turnover.