FDA makes acting CDER, CBER chiefs permanent
Michael Davis and Karim Mikhail.
HHS has moved to firm up the leadership at the FDA after a long period of uncertainty and disruption, upgrading the heads of the agency's centres governing drugs and biologics from acting to permanent status.
Michael Davis will now be formalised as director of the Center for Drug Evaluation and Research (CDER), while Karim Mikhail is confirmed as director of the Center for Biologics Evaluation and Research (CBER).
Davis took on the top job at CDER in May on a temporary basis after his predecessor, Tracy Beth Høeg, was fired after just six months in the role, and becomes the seventh director of the unit since the start of President Donald Trump's second term in January 2025.
Høeg was a close ally of former FDA Commissioner Marty Makary, who resigned from the agency earlier that month after 13 months. She stepped into the CDER role after Richard Pazdur stepped down over concerns about the politicisation of the FDA and the direction the agency was heading in vaccine policy.
Former MSD executive Mikhail, meanwhile, replaced Katherine Szarama as acting director of CBER, also in May. Szarama lasted only three weeks in the role, having stepped in after controversial head Vinay Prasad resigned for the second time, and is viewed as a casualty in a purge that followed Makary's resignation. He is the sixth CBER director since the start of 2025.
Kyle Diamantas – the FDA's top food official – has stepped into Makary's role as acting FDA Commissioner, but looks set to be replaced by White House policy aide Heidi Overton, an 'America First' figure who was nominated by Trump as the next FDA leader last month. Overton still has to be confirmed by the Senate, though observers expect her to clear the process.
Industry will be hoping that the appointments of Davis and Mikhail will be the start of a return to stability at the FDA after a turbulent and controversial period under HHS Secretary Robert F. Kennedy Jr, marked by massive job losses, an exodus in senior leadership, low morale, and fights over vaccines, the abortion pill, and the agency's bid to truncate the evidence required for drug approvals.
First FDA AI leader appointed
HHS has also named Jared Seehafer as its first Deputy Commissioner for Technology and Artificial Intelligence, taking the lead on "technology, software, and AI."
Seehafer has been an advisor to the FDA since early 2025 and was previously chief executive of Enzyme Corporation, a regulatory compliance software and services company.
HHS said in a statement that the new role "underscores the Trump administration's commitment to accelerating reliable AI innovation, modernising federal technology, and ensuring an effective regulatory framework for emerging technologies."
