Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human Services.
The FDA’s vaccines and biologics division will be helmed for the moment by an acting director. Katherine Szarama, who has served as Vinay Prasad’s deputy since December 2025, will ascend to the top job.
Prasad’s tumultuous tenure as head of the Center for Biologics Evaluation and Research (CBER) division came to an end on Thursday—for the second time. Prasad temporarily left the agency at the end of July after coming under fire for how the division handled the saga around Sarepta Therapeutics’ Elevidys. Shipments of the Duchenne muscular dystrophy gene therapy were temporarily halted after the deaths of two teenage patients. Ten days later, Prasad returned.
Before joining the FDA, Szarama worked as a social science research analyst and presidential management fellow at the Centers for Medicare and Medicaid Services and more recently as a program manager at the Advanced Research Projects Agency for Health, according to her LinkedIn profile. Szarama is a biophysicist who trained at Johns Hopkins and the Karolinska Institutet. —She also describes herself on LinkedIn as a “marathon mom.”
Szarama’s appointment, which a Department of Health and Human Services (HHS) spokesperson confirmed to STAT News, comes after FDA Commissioner Marty Makary revealed in early March that Prasad would step down as head of the division at the end of April.
Prasad, an oncologist and epidemiology professor at the University of California, San Francisco, had always planned to depart the agency at the end of a one-year leave of absence from UCSF, FDA Makary told The Wall Street Journal on March 6.
On Thursday, Makary told reporters that the “CBER selection process is going great,” but didn’t provide timeline details, according to Politico, which first reported the news.
For the time being, Szarama joins a long list of temporary directors within the HHS. Former Center for Drug Evaluation and Research Director George Tidmarsh subbed in for Prasad during his 10-day hiatus last summer. Tidmarsh himself was one of five different individuals to serve as CDER director in 2025, and the current division leader, Tracy Beth Høeg, is serving in an acting capacity.
Meanwhile, at the CDC, Jim O’Neill stepped in as acting director after Susan Monarez—the first Senate-confirmed director of the agency—was abruptly fired in August 2025 after a well-publicized spat with HHS Secretary Robert F. Kennedy Jr. O’Neill, who was also deputy secretary at the health department, left HHS in February. National Institutes of Health Director Jay Bhattacharya picked up the baton at the CDC later that month. He will presumably serve as acting head of the agency until the potential confirmation of Erica Schwartz, whom President Donald Trump nominated for the role earlier this month.
