As the FDA adjusts to life without Marty Makary, M.D., Fierce has learned that the numerous policy reforms he put in motion are set to remain intact, including the controversial Commissioner’s National Priority Voucher (CNPV) program.
Makary resigned two weeks ago following reports that President Trump planned to fire him, after the commissioner's reluctance to approve new fruit-flavored vaping products reportedly stoked Trump’s ire. Kyle Diamantas, head of the FDA’s food division, has stepped in as acting commissioner.
Of all Makary's initiatives, the CNPV—under which certain drug candidates are granted expedited reviews through an opaque selection process—grabbed the most headlines. The program has drawn concerns about increasing the risk of corruption and political influence entering the drug approval process, most notably after three psychedelic biotechs received vouchers following communications between President Trump and podcaster Joe Rogan.
Despite the controversy, the CNPV program—which has already led to approvals for Eli Lilly’s GLP-1 pill, Foundayo, and Regeneron’s gene therapy for a rare genetic deafness—will continue as-is under Diamantas.
A Department of Health and Human Services spokesperson told Fierce that there will be “no change to the name or direction of the CNPV program at this time.”
“Additional reforms initiated under the previous commissioner continue to move forward,” the spokesperson added.
Diamantas, a lawyer by training, previously led the FDA’s food division. With no scientific background to draw on, the acting commissioner may defer to career experts in the agency and avoid overriding their decisions. A key sore spot in Makary’s relationship with the biopharma industry was his agency’s tendency to reverse previous guidance when making approval decisions, frustrating sponsors.
Though it drew the most scrutiny, the CNPV is far from the only reform Makary put forward during his approximately one-year tenure. The FDA, along with other health agencies, started a vocal push to phase animal testing out of the drug development process, including building on efforts launched under former President Biden. Makary and former biologics head Vinay Prasad, M.D., whose appointment and tumultuous tenure became another point of conflict for the former commissioner, also together unveiled the plausible mechanism pathway to support approval of bespoke therapies.
When speaking about his reform efforts, Makary often shared a PowerPoint slide demonstrating how he wanted the FDA to enact change across the drug development timeline.
In addition to the CNPV program and reducing animal testing, the slide also highlighted the agency’s push for the use of Bayesian statistics, a real-time clinical trials pilot currently underway with AstraZeneca and Amgen and the adoption of artificial intelligence tools.
Notably, Makary and many of his deputies departed from the agency before they could announce what might have been their biggest reform effort yet—changes to the investigational new drug (IND) application and institutional review board (IRB) processes.
“We are looking to reduce and defer requirements for the IND application,” Makary said during a press conference last month for the FDA’s real-time trial initiative. “We are looking to reform the IRB process.”
At the time, Makary said a series of announcements to outline the details of these IND and IRB reforms would appear in the next one to two months, so that the U.S. “can retain our leadership position” in biotech over China. Less than a month later, Makary was out of a job. No such announcements have yet been made.