Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
Reforms set in motion by former Commissioner Marty Makary will remain in place at the FDA even after his departure—and even as the agency struggles to find permanent replacements for several of its highest-ranking officers.
In particular, the FDA will continue running the Commissioner’s National Priority Voucher (CNPV) program, Fierce Biotech reported on Tuesday. There will be “no change to the name or direction of the CNPV program at this time,” a spokesperson for the Department of Health and Human Services told Fierce, confirming the continuity of Makary’s programs.
BioSpace has reached out to the regulator for independent confirmation.
First announced in July last year, the CNPV program awards companies that align with certain federal priorities, including addressing key medical needs and lowering drug costs, with a speedy drug review. The effort has been impactful—leading to approvals for Eli Lilly’s weight-loss pill Foundayo and Boehringer Ingelheim’s lung cancer drug Hernexeos—but also controversial.
In February, Rep. Jake Auchincloss (D-MA) blasted the program as being “shrouded in secrecy,” calling it a system “under which drug approvals have been made almost wholly and in an unprecedented manner by the FDA’s political leadership.”
Other Makary-era reforms include the plausible mechanism pathway for personalized therapies, cutting back on animal testing and the one-trial requirement for drug applications. While the HHS spokesperson told Fierce that “additional reforms initiated under the previous commissioner continue to move forward,” it remains unclear if that applies to these particular efforts.
Makary resigned from the FDA earlier this month, ending what analysts at Capital Alpha called the “most damaging period in FDA history.”
The Trump administration hasn’t yet identified a potential permanent replacement for Makary, but temporarily taking the regulator’s reins is Kyle Diamantas, the FDA’s top food executive. More than a year into his tenure as deputy commissioner for Food, Diamantas has earned the respect of his colleagues and industry players, according to a Tuesday report from STAT News, which spoke with more than 10 stakeholders who had worked with Diamantas.
He has “earned the respect of career staff and the FDA stakeholder community. He’s a natural leader, but he isn’t going to rush to the cameras,” Scott Faber, senior vice president of the Environmental Working Group, told STAT. “Kyle is someone who listens to everyone.”
Alongside Diamantas, a handful of other temporary leaders have assumed top spots at the FDA. The Center for Biologics Evaluation and Research will for now be under the stewardship of Karim Mikhail. He succeeds Katherine Szarama, who herself was appointed acting director of the center after the exit of Vinay Prasad—perhaps the most controversial figure at the agency under Health Secretary Robert F. Kennedy Jr.
Meanwhile, Michael Davis will be interim head of the Center for Drug Evaluation and Research. He takes the reins from Tracy Beth Høeg, who herself followed Richard Pazdur, George Tidmarsh and Jacqueline Corrigan-Curay.
