The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
While Secretary Robert F. Kennedy Jr. has enjoyed a stable reign at the Department of Health and Human Services, the same cannot be said of some of his highest-level agency leaders. The top role at the CDC has seen no fewer than six names associated with it in the past 18 months. Meanwhile, the two major review units at FDA have each had five directors since Donald Trump took office in January 2025.
This level of turnover within the uppermost echelons of HHS is astounding. Appointed positions often turn over with a new administration, and deputies or other qualified experts are frequently called upon to serve in an acting capacity during those transitions. But atop three of the most powerful HHS divisions—the CDC, the FDA’s Center for Biologics Evaluation and Research (CBER) and its sister division the Center for Drug Evaluation and Research (CDER)—15 people have cycled through. And with all three of these high-turnover positions currently filled by temps, more are sure to come.
A regulatory nightmare for cell and gene therapy, rare disease
The most recent depature was a welcome one for the biopharma industry, with controversial CBER head Vinay Prasad leaving the agency late last week. He is returning to the University of California, San Francisco, after an apparently planned one-year leave of absence, though FDA Commissioner Marty Makary only made this information public in March. At that time, Stifel analysts characterized Prasad’s imminent exit as “a big win for biotech, especially for companies in the rare disease space.”
But the uncertainty around CBER’s leadership still hangs heavy over the industry. The FDA named Katherine Szarama, whom Prasad hired as his deputy in December, as the acting director on the last day of April, but Szarama is reportedly not on the short list to hold the position on a permanent basis.
CBER has been at the center of the FDA’s image problem since long-time regulator Peter Marks announced his sudden exit in late March 2025, despite having pledged to work with the new administration to continue advancing novel therapies to market. This turned out to be untenable, and he was forced out. That news sent the XBI biotech stock index spiraling to its lowest point in over a year.
Makary tapped Prasad to succeed Marks after Scott Steele stepped in on an acting basis for a month. But although he led CBER for a year, Prasad did not bring stability. Just three months into his tenure, he left the FDA in the middle of a spat with Sarepta Therapeutics, only to return 10 days later at Makary’s behest.
Back at CBER, controversy continued to follow Prasad. In addition to being at the center of surprising regulatory decisions, news broke in February that Prasad was being investigated by the FDA for creating a toxic work environment.
“With Prasad gone, there may be less drama, less personnel angst, and perhaps a more informed regulatory approach to FDA decisions,” Capital Alpha Partners said in a May 3 investor note. “However, we think that many of the underpinnings and views that led to some of his questionable actions remain, along with the overall damage done to agency capabilities and experience.”
The FDA’s drug division isn’t any better
CDER has also seen a revolving door of directors and fair share of controversy. George Tidmarsh was the first to serve as permanent director of the center since Patrizia Cavazzoni left of her own accord after serving four years under President Joe Biden, but he lasted barely longer than three months. Tidmarsh resigned amid a probe into his personal conduct after he lambasted Aurinia’s approved lupus nephritis therapy on LinkedIn. The incident resulted in a complaint from Aurinia boardmember and infamous activist investor Kevin Tang followed by a lawsuit from the company, in addition to Tidmarsh’s untimely FDA exit.
Makary eventually persuaded longtime oncology regulator Richard Pazdur to step in, bolstering the XBI and sending optimism through the industry, but his tenure was even shorter than Tidmarsh’s. Three weeks after accepting the role, Pazdur announced his sudden retirement. He later told The Wall Street Journal that he left after being pressured to support a policy shift to requiring only one clinical trial for approval.
“Dr. Pazdur’s departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA,” BIO President John Crowley wrote in a prepared statement at the time. “This constant turmoil is undermining America’s leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.”
Tracy Beth Høeg, Makary’s former aide, now serves in an acting capacity, having stepped up to the plate in December. Six months later, there has been no further news from the FDA on a possible permanent CDER director.
The face of U.S. public health is crumbling
Pazdur’s account of why he left the FDA strikes strong similarities to the leadership churn in the CDC’s chief position. When Trump took office, Susan Monarez became acting CDC director, but after she was nominated for the permanent position, she had to step aside. Once she was confirmed by Congress and reinstated at the end of July, Monarez lasted all of 28 days. She exited HHS in a public he-said-she-said battle with Kennedy, with Monarez testifying in front of Congress that she was told to pre-approve recommendations from a recently revamped vaccine advisory committee, and Kennedy calling her a liar.
Jim O’Neill, deputy secretary at the Department of Health and Human Services, was tapped as an interim solution, but he left abruptly in February, again leaving the CDC without a leader. Currently, the country’s federal public health agency is being overseen by NIH Director Jay Bhattacharya. Trump nominated Erica Schwartz to the position last month, but she has yet to be confirmed by Congress.
Whether she or whoever lands as the next permanent director of CBER or CDER can restore the crumbling public and industry trust in these agencies remains to be seen. But if any of them can last more than a few months, it would be a start.
For now, not only are the CDC, CBER and CDER all lacking permanent stable leadership, but tensions at the FDA are growing to a point where one has to wonder if even Makary’s job is safe. And Kennedy himself has faced plenty of calls to be removed from office.
While I won’t recount the many grievances people have against Kennedy’s decisions as health secretary, I would argue that the inability to fill top positions—and keep them filled—is the ultimate reflection of the men at the top. And the consequences of this leadership instability will affect everyone, from Kennedy himself to the biopharma industry and, most importantly, the American people.
