The Commissioner’s National Priority Voucher program is coming to an end. That is, companies can still submit applications, but if they do, they won’t go anywhere. That’s according to six anonymous sources who spoke with Reuters.
As Heidi Overton’s Senate confirmation for FDA commissioner hangs in the balance, awaiting a vote from the now lame-duck legislative body, the FDA has shelved the CNPV program, which was launched by former Commissioner Marty Makary in July 2025 to shorten review times for certain products aligning with national priorities.
Of the 22 drugs that secured a voucher, 12 have been approved since the program’s inception in June 2025, according to Reuters, including five since Makary’s departure in May.
There have been no new vouchers awarded since Makary left, however, and an executive council of political appointees that oversaw drug reviews “has gone dormant,” according to internal documents reviewed by Reuters.
Neither of the most recent approvals for CNPV-holder—Revolution Medicines’ pancreatic cancer drug Rasonque and Merck’s cholesterol pill Lipfendra—were vetted by the executive council, Reuters reported.
Companies were told by agency leadership that the FDA is not moving forward with the CNPV program but is keeping applications open, one source told Reuters. When companies submit them, however, they don’t advance, according to this source.
There has been no official guidance from the FDA on the program, “nor is it clear the extent to which this may impact companies with an existing CNPV rather than new applicants to the program, ” RBC Capital Markets analysts wrote to investors on Thursday morning.
“FDA’s commitment to its core mission remains unchanged, and work under the Commissioner’s National Priority Voucher (CNPV) Pilot Program is ongoing,” an FDA spokesperson told BioSpace in an email. “FDA career staff continues to evaluate applications granted a CNPV and meet commitments for accelerated review and enhanced engagement as we assess best practices learned under this pilot program.”
Two CNPV holders, Compass Pathways and Usona Institute, have recently submitted applications for their psychedelic therapeutics, COMP360 for treatment-resistant depression and PSIL201 for major depressive disorder, respectively.
Compass Pathways has completed an FDA filing for COMP360, with an expected launch in the first half of next year. The update follows a reported regulatory submission for Usona Institute’s own psilocybin candidate for depression last Monday.
November 9, 2026
·
3 min read
·
“While it is not fully clear how these updates may impact COMP360, this may add incremental risk to timelines,” RBC said. But the analysts noted that COMP360 has breakthrough status and should thus be eligible for priority review, the analysts added, so the impact from any change in timing “should be manageable.”
RBC remained positive on Compass’ shot at a regulatory greenlight, saying they “do not see added risk on an approval (est. 85% PoS) given CMPS’s strong data which stands on its own and should clear a traditional FDA review.”
Overton vote next week
News about the CNPV program’s possible closure comes as industry watchers are debating Overton’s chances of passing an upcoming Senate vote to become FDA commissioner.
“While a vote on Dr. Overton’s nomination has been scheduled for Nov. 18, there is clearly uncertainty over whether a majority can be reached amongst members present at the vote given impending changes in the committee members,” William Blair wrote on Thursday after a conversation with representatives from LMH Strategic Solutions on the implications of the recent midterm elections for the healthcare and life sciences sector.
“Should Dr. Overton not pass the committee vote, there could also be changes in the current acting commissioner, with news outlets reporting that Sara Brenner could return as acting commissioner in 2027,” the analysts wrote.
During a Senate hearing in late September, U.S. senators grilled Overton on her ability to “stand up” to President Donald Trump.
“This committee needs to know whether you’ll be radically honest, whether you will use your authority to stand up for sound science and protect children’s health,” outgoing Senate Health, Education, Labor, and Pensions (HELP) Committee chairman Bill Cassidy (R-LA) said during hearing.
HPS Group President and regulatory consultant Steven Grossman cast doubt on Overton’s chances of securing the position.
“Controversial nominations rarely advance during a lame-duck session,” Grossman wrote in a piece for MedPage Today last Friday.
“Given the White House affiliation with Heidi Overton, MD, PhD, and her weaker credentials compared to her predecessors, I see no way senators would confirm her as FDA commissioner in the lame-duck session,” Grossman continued. “Obviously, her odds would be even worse next year with a Democratic-led Senate.”
In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as about her views on vaccines and abortion drugs.
September 24, 2026
·
4 min read
·
