While outgoing Commissioner Marty McCulley’s resignation is still pending, another top regulator may be on his way out of the agency.
Tracy Beth Hogue, MD, who was appointed acting director of the agency’s Center for Drug Evaluation and Research (CDER) following the retirement of veteran oncologist Richard Pazdol, MD, in December, is expected to follow in McCurry’s footsteps, Reuters reported on Friday, citing three sources familiar with the regulator’s internal plans.
Fierce Pharma has contacted the Department of Health and Human Services and Mr. Høeg directly for comment on this report.
“HHS and FDA do not comment on personnel matters,” an HHS spokesperson told Reuters.
Reuters said in a report that the CDER chief’s resignation is likely, but the decision has not yet been finalized.
Still, news outlets have suggested that her departure will mark a broader reorganization of the U.S. health agency, with the White House reportedly seeking to take a more active role in FDA matters to avoid controversy over issues such as vaccines ahead of this fall’s midterm elections.
Specifically, Medicare Secretary and CMS Deputy Administrator Chris Klomp, who ranks just below HHS Secretary Robert F. Kennedy Jr., is seeking to purge the FDA of controversial appointees in favor of more traditional leadership at the federal health agency following McCurry’s resignation earlier this week, Reuters reported.
Mr. Fierce asked HHS directly about the allegations regarding Mr. Klomp’s role in the reported leadership shakeup, but did not receive a response in time for publication.
Holly Fernandez Lynch, a medical ethicist and regulatory expert at the University of Pennsylvania School of Medicine, told Fiers: “This news is not surprising given Mr. McCurry’s resignation and his alliance with Mr. Hague.” “It’s scary for any organization to have all its leaders leave, because it creates a lot of uncertainty and can make it difficult to even carry out day-to-day operations.”
Additionally, the vague reasons behind the series of departures make it unclear what the agency’s overarching vision is, Fernandez-Lynch added.
“We don’t know, for example, whether the White House is signaling a shift on vaccines or whether they want a different approach to rare diseases or mifepristone,” she said. While some in the biopharmaceutical industry celebrate the recent departures of McCurry and Prasad, the immediate impact of this leadership change brings further uncertainty.
“I don’t know if we’re going to have the predictability we’re hoping for for a while,” Fernandez-Lynch said.
Mr. Hegg was appointed to lead CDER late last year on behalf of Mr. Pazdur, a well-respected veteran regulator with an illustrious career at the FDA, who stepped down after a short stint.
Mr. Pazdur has since been a vocal critic of the agency’s operations under the second Trump administration, particularly pointing to the loss of career employees and senior expertise in last year’s layoffs.
Hague, a doctor who became famous for challenging U.S. vaccine policy during the COVID-19 pandemic, co-authored a paper with McCurry and fellow recently retired FDA leader Dr. Vinay Prasad on the risks to four young people of the 2022 coronavirus vaccine booster.
Part of Hoog’s legacy during her time at the federal health agency will likely come down to her leading role in the HHS evaluation that led to the CDC’s repeal of the U.S. pediatric vaccine schedule in early January. The review, co-led by Hagg, compared the U.S. immunization schedule with schedules in other developed countries, and the data ultimately supported “a more focused schedule that protects children from the most serious infectious diseases while increasing clarity, compliance, and public confidence,” former CDC acting director Jim O’Neill said earlier this year.
Those changes to the childhood vaccination schedule were temporarily blocked after a federal judge in Boston rejected key parts of HHS’s recent vaccine policy, a finding the agency has promised to appeal.
As for Mr. McCulley, it was revealed on Tuesday that the commissioner had hung up his hat in the face of the issue, and reports of his resignation appeared to be confirmed by President Donald Trump later that day. Politico and other outlets reported this week that Kyle Diamantas, currently the FDA’s deputy commissioner for food, will lead the FDA on his behalf.
McCurry has been at the center of controversy in recent months over decisions regarding the abortion drug mifepristone and fruit-flavored e-cigarettes. The Secretary’s National Priority Review Voucher Program, which he launched and is designed to significantly speed up the review schedule for products that meet vague national interests, has also come under scrutiny for potentially encouraging corruption and undermining the FDA’s regulatory rigor.
This week, hundreds of leaders from across the biopharmaceutical field signed their endorsement of Pazdur as a candidate to replace Mr. McCurry, underscoring the stability 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 turmoil surrounding the FDA is already having a clear impact on the drug approval process. Despite yesterday reporting a major victory in Phase 2 of its Duchenne muscular dystrophy gene therapy, Regenxbio is refraining from approaching the FDA until “the issues are resolved,” the company’s chief medical officer Steve Pacora, MD, told Fierce.
“Obviously, the FDA is in a very dynamic period,” Pacora said.
