After refusing to resign, CDER head Høeg is fired

The turmoil at the FDA continues with the news that Tracy Beth Høeg has been fired as acting head of the FDA's Center for Drug Evaluation and Research (CDER) after just six months in the role.

According to the FDA website, Høeg has been replaced by deputy CDER head Michael Davis, who has been in that role for around a year and previously served in the agency's Office of New Drugs (OND).

A close ally of former FDA Commissioner Marty Makary, who resigned from the agency earlier this month, Høeg was a controversial appointment at CDER. A sports medicine physician and epidemiologist with little in the way of experience in medicines regulation, she stepped into the CDER role on the departure of Richard Pazdur, a respected regulator who said his decision to retire stemmed from concerns about the politicisation of the FDA and the direction the agency was heading down in vaccine policy.

Høeg has a history of vaccine scepticism, and like Makary and another ally – the now-departed Center for Biologics Evaluation and Research (CBER) head Vinay Prasad – opposed federal COVID-19 policies during the pandemic.

She made the move to CDER from CBER, where she was working as a senior advisor for clinical sciences in the Office of the Commissioner, and has been a prominent figure in the drive to reduce the number of recommended shots in the US's childhood immunisation schedule, and led a panel investigating the safety of antidepressants in pregnancy that has been accused by medical groups of spreading misinformation.

In a social media post on Saturday, Høeg confirmed that she was fired, telling the MD Reports Substack blog that she was told by unidentified senior FDA officials that she should resign just days after Makary announced his departure. The FDA has also now confirmed that Karim Mikhail has been named as acting CBER director to replace Prasad.

Kyle Diamantas – the FDA's top food official – has stepped into Makary's role as acting FDA Commissioner, and calls have already gone out for Pazdur to return, with more than 100 biopharma leaders signing a letter to President Trump recommending him for the role.

Many consider it unlikely that he would return to an administration in which vaccine sceptic Robert F Kennedy Jr is still HHS Secretary, with other potential runners reported to be 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.

With Makary, Prasad, and now Høeg leaving the FDA – already hit hard by sweeping job losses and the departure of a raft of experienced regulatory leaders – questions are now being asked about the direction of the FDA and potentially a return to more conventional operations.

Controversy surrounds the FDA's push for fast-tracked product approvals and other measures, such as relying on one, rather than two, pivotal trials to support approvals, that some fear are undermining established processes and patient safety.

Industry, meanwhile, has been unhappy about what it claims has been inconsistency in drug reviews and policy changes involving vaccines, while there has also been concern about a failure by the FDA to release public results of investigations into the safety of COVID-19 and shingles shots that some claim do not support Kennedy's anti-vaccine agenda.