A newly published staff manual for the FDA Commissioner’s National Priority Voucher program provides the most extensive documentation yet for an initiative that has come under criticism for its lack of transparency. The FDA plans to provide additional information, including possibly draft guidance, in the “coming months,” according to newly updated information on the agency’s website.
The Commissioner’s National Priority Voucher program: A recap
- The CNPV program offers selected drugmakers a voucher for participation in a new FDA acceleration mechanism “that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission,” according to an agency announcement on June 17, 2025. Key features of the program include enhanced communications with the agency, the opportunity for advance submission of the chemistry, manufacturing and controls section of the application and a “tumor board”-style review from a multidisciplinary team. (A tumor board is a process for planning cancer treatment by convening specialists from different health care areas.) Companies can submit a brief statement of interest to the agency requesting the inclusion of a drug program, while agency staff may also nominate candidates. [Read AgencyIQ’s initial analysis here.]
- The program was initially intended to benefit applications meeting at least one of four criteria: Addressing “a health crisis in the U.S.,” delivering “innovative cures,” meeting “unmet public health needs,” or helping increase domestic drug manufacturing of a critical medicine, according to the announcement and an accompanying Q&A page. A few weeks after the original announcement, a fifth criterion joined the list – affordability. Unlike the agency’s other priority review vouchers, CNPVs are not transferable.
- AgencyIQ previously noted how the CNPV program repurposes the agency’s existing authorities to prioritize certain product applications, with an approach that mirrors that of existing programs such as the STAR pilot program, Real-Time Oncology Review pilot program, rolling review authorities and coronavirus treatment action program.
- The FDA has selected 18 drug programs for inclusion in its voucher program and approved one. The first group of nine drug products was announced Oct. 16, 2025, followed by the Nov. 6 announcement of six additional designated drugs. The FDA on Dec. 9, 2025, granted the first CNPV approval, to a U.S.-manufacturing version of the generic antibacterial drug Augmentin XR (amoxicillin/clavulanate potassium). Soon thereafter, the FDA revealed it had “proactively” awarded a CNPV to Johnson & Johnson’s multiple myeloma drug combination following presentation of trial results at a medical meeting earlier in the month. And on Dec. 19, 2025, the agency issued two more to drugs from Merck for cholesterol and cancer. [AgencyIQ is monitoring all the CNPV awards as they get announced. We’ve also done a deep dive on the program’s first six months, which you can read here.]
- There have been signs of strain. According to Reuters, the agency delayed reviews of two selected medicines, Sanofi’s Tzield (teplizumab-mzwv) and Disc Medicine’s bitopertin, after agency scientists raised questions about their safety and efficacy. Assessment of two other designated drugs, Boehringer Ingelheim’s zongertinib and Eli Lilly’s orforglipron, are also taking longer than expected, according to Reuters. The CNPV program has also come under fire for its potential to politicize the scientific review process. Speaking at a STAT News event at the J.P. Morgan Healthcare Conference on Jan. 13, 2026, former FDA leader RICHARD PAZDUR said the firewall between political leaders and the agency’s scientific reviewers “has been breached,” highlighting the CNPV program’s lack of transparency and process. Others, such as ousted Center for Drug Evaluation and Research Director GEORGE TIDMARSH, previously raised concerns.
- Political objectives are central to the program, however. While criticism has focused on the role played by political appointees in decisions, the program’s stated goal is to advance national priorities such as domestic manufacturing and affordability. Makary emphasized this on a “Freakonomics” podcast released Jan. 16, 2026: “At the FDA, we’re telling companies that if they promise to provide prices comparable with other developed nations around the world – that is, give us the best price – then we’ll give them priority in the review,” Makary said. The FDA awarded a voucher to EMD Serono in October 2025, Eli Lilly and Nov Nordisk in November 2025, and Merck in December 2025 as part of “most-favored nation” pricing deals announced by President DONALD TRUMP.
Staff manual offers sought-after details on CNPV operations
- The FDA provided extensive new documentation about the CNPV program and its operation on Feb. 9, 2026, publishing online a staff manual and updating the program’s website. Taken together, this newly released information helps clear up questions about the role of the tumor board-style council, its membership and who ultimately signs off on decisions regarding voucher selection and drug approval. The agency also signaled that it plans to release additional documentation in the coming months, possibly through draft guidance, and solicit stakeholder input through a public comment period.
- The FDA intends for the office or division director of the relevant review team to “serve as final signatory” on approval decisions for CNPV-designated drugs, according to slides from a Feb. 3 town hall that the agency posted online Feb. 9. Supervisors above them in the FDA hierarchy “may override pursuant to existing procedures.” Previously, the tumor board-style council was reportedly tasked with making the final call on approval. This deviated enough from the agency’s normal procedures that former CDER director Tidmarsh raised questions about the program’s legality. And a recent Associated Press report indicated Principal Deputy Commissioner SARA BRENNER previously declined to sign off on decisions “after looking further into the legal implications.” An online Q&A document updated Feb. 9 now indicates that the council only makes a non-binding recommendation to the relevant center director. STAT News reported this change on Feb. 3.
- The council still plays a central role, however. The newly released staff manual, which was first approved Dec. 5, 2025, and updated Jan. 15, 2026, describes two principal tasks. The council provides recommendations to a certain “delegated official” on voucher selection, and to the relevant center director on CNPV drug approvals. In the first role, the council convenes to discuss voucher candidates with relevant subject matter experts, providing input that the delegated official uses to make a final determination on selection. The manual indicates this official would typically be the deputy chief medical officer, a position currently filled by MALLIKA MUNDKUR. For the second task, the council will meet in the weeks prior to a CNPV drug’s target action date to hear a presentation and decision recommendation from the primary review team. They’ll then make their own recommendation by simple majority vote, which the relevant center director considers alongside other information to make a final call on approval. Following that, the manual indicates the FDA will “proceed through normal administrative procedures,” such as finalization of reviews, final labeling discussions and action letter preparation.
- The manual also describes the documentation that should accompany these processes. The deputy chief medical officer (or other delegated official) memorializes the initial screening of CNPV nominations in a “Selection Consideration Summary,” which documents a candidate’s alignment with national priorities, its likely public health impact, the overall application readiness, any review resource constraints and known risks or uncertainties. Voucher selection is maintained in the administrative record in a memorandum that describes the “high-level” rationale behind the decision, the national priority areas implicated and the council’s input. Documentation of the CNPV approval decision and the council meeting that precedes it is more extensive. An agenda and background materials for each council meeting on drug approvals will be stored by the Office of the Chief Medical Office and, if an approval is granted, published on the FDA’s website alongside the rest of a drug’s “action package.” The FDA will also maintain in an official system of record minutes for each council meeting that identify attendees and describe the voting outcome.
- The council includes 10 members in addition to “relevant subject matter experts,” such as an office or division director or the director’s delegate. The FDA Commissioner chairs the council and moderates discussions but does not vote. The other members include the principal deputy commissioner, the chief medical and scientific officer, deputy chief medical officer, the heads of both CDER and the Center for Biologics Evaluation and Research, their respective deputies, the principal medical advisor to the commissioner and the senior advisor to the commissioner for clinical sciences. As CBER director and chief medical and scientific officer, VINAY PRASAD currently holds two of the designated titles, but the manual indicates he will represent only one council seat. Prior to her elevation as CDER Director, TRACY BETH HØEG was senior adviser to the commissioner for clinical sciences. It’s not clear whether her prior role has been backfilled since her promotion.
- In the Q&A document, the FDA signaled it intends to provide “additional documentation” in the “coming months.” That will likely come in the form of draft guidance, the FDA indicated in its town hall slides. The slides also show the agency plans to incorporate center feedback into a draft Standard Operating Procedures and Policies document, which are used by CBER. Outside stakeholders may also get an opportunity to provide feedback, as the FDA indicated in its Q&A that it plans to solicit comment through a Federal Register notice and through “listening sessions.”
Analysis: The FDA has been implementing, then documenting
- The FDA moved quickly to expand the CNPV program following its June launch, issuing 18 vouchers after initially indicating it planned to select “no more than five during the initial year.” Now, the agency appears to be prioritizing the caseload it has already built up. In the Q&A document, the agency indicated that is “primarily focused on implementation of the pilot.” It will continue to accept statements of interest from companies, however, and “may award” additional vouchers. The new staff manual – as well as plans to issue draft guidance and solicit outside feedback – also signal the agency is working to move the program out of pilot phase and into something more sustainable. The FDA has also provided more clarity regarding the intended one- to two-month review timeline by adjusting its presubmission requirements and setting a target timeline for filing review.
- This documentation is happening after the agency already made many of its CNPV decisions, however. The staff manual guide was originally approved by Makary on Dec. 5, 2025, according to a change log at the bottom of the document. It was subsequently updated and Makary approved the current version on Jan. 15, 2025. The FDA issued 15 of the 18 total vouchers it’s granted prior to the Dec. 5 memorialization of a process and procedure for selection. A Nov. 21 report from Stat News indicated that the CNPV council held its first vote on approval of a voucher program in October and, at that time, did not include the relevant review team. This is not typical for the agency, as RICHARD PAZDUR, the former head of the FDA’s Oncology Center of Excellence and briefly CDER director before leaving the agency, recently pointed out: “One of the problems, I think, when this was brought out wasn’t a clear delineation of what the process was going to be,” Pazdur said an event hosted by the Friends of Cancer Research on Feb. 5, 2026. “It’s the proverbial building the plane while you’re flying it.”
- The FDA’s decision to place CNPV approvals back in the hands of review teams addresses some of the criticism levied against it. For example, Representative JAKE AUCHINCLOSS, (D-Mass.), who serves on the House Energy & Commerce Committee, wrote to the FDA in September 2025 about his concerns the initial CNPV decision-making process would “politicize the FDA’s approval process.” A follow-up letter Auchincloss sent in February raised further questions about the agency’s voucher selection, noting that the FDA had not publicly posted any documents explaining its process. In a Nov. 2, 2025, interview following his ouster as CDER director, Tidmarsh told The New York Times that he thought the CNPV was “going to basically change the entire paradigm of the legal underpinnings of drug approvals that have for decades supported the actions on the safety and effectiveness of drugs.” Shifting the council to a recommending role and charging office or division directors with making a final recommendation on approval moves the CNPV process closer to the FDA’s usual review procedure. Publishing some documentation, meanwhile, could head off criticism over lack of transparency (or, possibly, spur demands for more.)
- While council votes no longer represent the final recommendation on approval decisions, the group still exerts considerable influence. Office and division directors report into center heads, who are represented on the council. While the staff manual guide indicates a reviewing director can apply “independent discretion,” it also asks them to formally consider the recommendations of both the review team and the council, which consists of the agency’s most senior leadership. A council vote that’s unanimous or strongly in favor one way would represent significant institutional pressure on an office or division director, regardless of that director’s or the review team’s opinion. The manual does note that the reviewing director will present in writing a final recommendation to the primary review team “whether or not the rest of the council agrees.”
- The manual provides more detail on the internal factors that may be considered in screening and selecting voucher recipients. The manual indicates the council should seek input from FDA offices or review divisions on operational feasibility concerns, anticipated review complexity, and timing or staffing constraints. The delegated official, such as the deputy chief medical officer, can then select voucher recipients, defer a decision “pending additional information,” or decline selection “without prejudice to future consideration.”
- More changes could come. The manual explicitly notes the CNPV program’s status as a pilot and indicates the selection process will “maintain flexibility appropriate to a pilot program.” For instance, the FDA may refine selection criteria or processes over time, the manual indicates, while process deviations “may occur when justified by programmatic needs.” Should any material deviations take place, the agency intends to document them to “support transparency and learning.” Already, the FDA has “enhanced” its presubmission requirements based on its initial experience, asking sponsors to submit additional information before filing. The town hall slides, meanwhile, indicate the existence of a “CNPV Pilot Advisory Group,” with whom the offices of the commissioner and chief medical officer intend to meet to “discuss implementation of the program and necessary refinements.” When posted, the planned Federal Register notice soliciting stakeholder input is likely to draw substantial comments as well.
Featuring previous research by Amanda Conti.