The FDA has quietly shelved the Commissioner’s National Priority Voucher (CNPV) pilot program, a controversial speedy review process launched by former agency head Marty Makary, M.D., Reuters reports, citing six sources familiar with the matter, as well as internal documents.
Meanwhile, the FDA also appears to have paused publishing complete response letters after briefly halting—and then resuming—the practice in July.
The CNPV was designed to accelerate reviews for drugs and companies that support U.S. national interests, such as meeting large unmet medical needs and onshoring of development and manufacturing. The ultra-accelerated process shortens the FDA’s review from the regular 10 months to just one to two months.
The pilot’s rollout since June 2025 has been controversial, as public concerns run the gamut from political favoritism and lack of transparency to straining the FDA’s bandwidth. So far, 22 drug programs have received the voucher, with 12 approvals and one rejection to date.
The reported pause doesn’t appear to be permanent. In a statement to Fierce, an HHS spokesperson said work under the CNPV is “ongoing.” At least for programs that have already received a CNPV, the FDA is committed to executing on the promised timeline.
“FDA career staff continue to evaluate applications granted a CNPV, meet commitments for accelerated review and enhanced engagement, and assess best practices emerging from the pilot program,” the spokesperson said.
The FDA is still accepting applications for CNPV but is not reviewing or granting new ones, Reuters reported, citing one person familiar with the process. The most recent CNPV grants appear to be for a trio of psychedelics in April following an executive order from President Donald Trump, and one disclosed in May for Partner Therapeutics’ cholangiocarcinoma drug Bizengri. There’s no public record of any new CNPVs following Makary’s resignation as the FDA commissioner in mid-May.
The council of FDA leadership responsible for making critical decisions around CNPV has gone dormant, Reuters asserted, citing internal documents. The FDA’s recent review documents for Revolution Medicines’ pancreatic cancer drug Rasonque, which was among the cohort of nine programs that got the initial batch of CNPVs, do not show any involvement of the council. Instead, the review was conducted and decided by the Oncology Center of Excellence under the pre-existing real-time oncology review framework.
Controversy over the program flared up in May when Sanofi reportedly asked that its diabetes drug Tzield be withdrawn from the CNPV track after then-director of the FDA’s Center for Drug Evaluation and Research, Tracy Beth Høeg, M.D., Ph.D., tried to overturn staff’s recommendation for approval.
After a leadership overhaul, the FDA in June held a public hearing about CNPV. While existing CNPV beneficiaries voiced support for the program by highlighting a sense of collaboration, they also offered suggestions for improvement, such as clearer feedback from the review council.
The medical and academic communities were more critical. Peter Lurie, M.D., a former FDA employee and current president of the Center for Science in the Public Interest, called for the agency to shut down the pilot due to concerns about “politicization in voucher selection and review, strained agency resources and lack of transparency.”
In a statement to Fierce Thursday, the HHS spokesperson said: “FDA will continue advancing reforms aimed at improving efficiency, accelerating scientific review, strengthening public trust, and delivering measurable results for patients, families, and consumers.”
The legality of the CNPV program has also drawn scrutiny. In a February letter (PDF) to Makary, Rep. Jake Auchincloss, a Democratic congressman from the biotech hub that is Massachusetts, suggested that the agency does not have statutory authority to establish CNPV, and he targeted the political nature of the review council.
“My investigation has revealed an FDA replete with conflicts of interest, illegal maneuvers, and political interference,” Auchincloss wrote in the letter.
CNPV isn’t the only initiative launched by Makary that has faced legal pushbacks. Last summer, touting “radical transparency,” the FDA started publishing all complete response letters in a public database in real-time. However, in a Citizen Petition filed in April, the law firm Covington & Burling argued that the practice could be violating federal laws meant to protect confidential information.
As the FDA has included a legislative proposal in its fiscal year 2027 budget request, asking Congress to grant it clear statutory authority to publicly disclose information related to CRLs, the agency appears to have put new releases on hold.
No new entries have been logged into the FDA’s CRL database for the past three months. The most recent one was a manufacturing-related rejection for ITM Isotopes Technologies’ radiopharmaceutical candidate ITM-11 in early August.
Following the legal challenge and after a three-month hiatus, the FDA had initially confirmed to Fierce in July that it had halted the release of those rejection letters. But then the agency released a new batch of CRLs and told Fierce that it plans to publish more “appropriately redacted” CRLs.
In response to Fierce’s questions about CRL disclosure policy Thursday, an FDA spokesperson said: “Transparency and public confidence are central to the FDA's mission. The FDA remains committed to the proactive release of Complete Response Letters and will continue to publish appropriately redacted CRLs.”