With the ink barely dry on outgoing commissioner Marty Makary’s resignation, another top regulator may be heading for the exit at the FDA.
Tracy Beth Høeg, M.D., Ph.D.—who was named acting director of the agency’s Center for Drug Evaluation and Research (CDER) following the departure of veteran oncologist Richard Pazdur, M.D., last December—is now expected to depart in Makary’s footsteps, Reuters reported Friday, citing three sources familiar with internal plans at the regulator.
Fierce Pharma has reached out to the Department of Health and Human Services and to Høeg directly for comment on the report.
A spokesperson for HHS told Reuters that “HHS and FDA do not comment on personnel matters.”
Reuters clarified in its report that the CDER chief’s departure is likely, but that the decision has not yet been finalized.
Still, the news outlet suggested that her exit will define a broader shuffling of U.S. health agencies—with the White House reportedly trying to play a more active role in FDA matters to skirt controversy around issues like vaccines ahead of midterm elections this fall.
Specifically, Chris Klomp, the director of Medicare and deputy CMS administrator—who sits just below HHS secretary Robert F. Kennedy Jr.—has been seeking to staff federal health agencies with more conventional leadership picks and purge the FDA of controversial appointees following Makary’s exit earlier this week, according to Reuters.
Fierce asked HHS directly about the allegations regarding Klomp’s role in the reported leadership shakeup but did not receive a response by publication time.
“The news isn’t surprising given Makary’s departure and Høeg’s allyship with him,” Holly Fernandez Lynch, a medical ethicist and regulatory expert at the University of Pennsylvania School of Medicine, told Fierce. “It’s terrible for any organization to have all its leaders depart because it creates loads of uncertainty and can make it difficult to get even the day to day work done.”
What’s more, the murky reasoning behind the suite of departures make it unclear what the overarching vision for the agency is, Fernandez Lynch added.
“We don’t know whether the White House is signaling a shift on vaccines, for example, or if they want a different approach to rare disease or mifepristone,” she said. Though some in the biopharma industry have celebrated the recent departures of Makary and Prasad, the immediate effect of this leadership turnover is more uncertainty.
“I don’t know that we’re going to see the desired predictability for quite some time,” Fernandez Lynch said.
Høeg was tapped to lead CDER on an acting basis late last year after Pazdur, a respected veteran regulator with a storied career at the FDA, departed after a brief stint in the position.
Pazdur has since been a vocal critic of operations at the FDA under the second Trump administration, pointing to the loss of career staff and senior expertise amid reductions in force last year, among other concerns.
A physician, Høeg rose to prominence for challenging U.S. vaccine policy during the COVID-19 pandemic, co-authoring a paper with Makary and another recently departed FDA leader, Vinay Prasad, M.D., on the risks of COVID vaccine boosters four young adults in 2022.
Part of Høeg’s lasting legacy during her stint in the federal healthcare apparatus will likely come down to her leading role in an HHS assessment that led to a gutting of the CDC’s U.S. pediatric vaccine schedule in early January. The assessment, co-led by Høeg, compared U.S. immunization schedules to those in other developed nations, with the data from that inquiry ultimately supporting a “more focused schedule that protects children from the most serious infectious diseases while improving clarity, adherence and public confidence,” former acting CDC director Jim O’Neill said earlier this year.
Those changes to the childhood vaccine schedule have been temporarily blocked after a federal judge in Boston knocked down significant parts of HHS’ recent vaccine maneuvers—an outcome the department has pledged to appeal.
As for Makary, it became clear the embattled commissioner was hanging up his hat on Tuesday, with reports of his exit seemingly confirmed by President Donald Trump later in the day. Now, all eyes are on Kyle Diamantas, the FDA deputy commissioner for food, to lead the agency in an acting capacity, Politico and others have reported this week.
Makary had drawn controversy in recent months around decisions involving the abortion pill mifepristone, as well as fruit-flavored e-cigarettes. The Commissioner’s National Priority Review Voucher program he launched—which seeks to significantly accelerate review timelines for products that align with vague national interests—has also attracted scrutiny over its potential to encourage corruption and erode the FDA’s regulatory rigor.
Hundreds of leaders from across the biopharma spectrum this week signed their support for Pazdur as a potential permanent replacement for Makary, highlighting the stability they believe he could bring to the FDA.
Still, Pazdur told Fierce Biotech in April that he was unlikely to return to the agency under the current presidency.
The recent turbulence atop the FDA is already having a demonstrable impact on the drug approval process. Despite reporting a strong phase 2 win for its Duchenne muscular dystrophy gene therapy yesterday, Regenxbio is holding off on approaching the FDA until the “dust settles,” as the company’s Chief Medical Officer Steve Pakola, M.D., told Fierce.
“Obviously, it’s kind of a pretty dynamic time at the FDA,” Pakola said.
