BY Blinn E. Combs, Esq. and Michael R. Alexander, Esq., Brown & Fortunato, P.C.
On June 17, 2025, a little over two months after initiating large-scale layoffs at the agency, the federal Food and Drug Administration (“FDA”) announced a new Commissioner’s National Priority Voucher (“CNPV”) program. The CNPV aimed to give voucher recipients the opportunity to shorten new drug approval timelines from 10-12 months down to 1-2 months.
The program aims to address four stated national priorities, fast-tracking new drugs or enhanced production methods that address national health crises; introduce innovative therapies; address large, unmet medical needs; or improve affordability. Applicants need not address all four priorities. Each developer is limited to one voucher application which, if rewarded, would need to be applied within two years of receipt. Vouchers are applicable to any stage of development. In addition, the CNPV would not disrupt or alter existing expedited review programs, such as priority review, accelerated approval, fast-track designation, or breakthrough therapy designation.
Although the announcement included few details about the review or selection process, an accompanying FAQ noted that submissions were being accepted and would be “evaluated by a multidisciplinary review committee.” Further information was released in late July. This announcement noted the additional priority of onshoring drug development and manufacturing to strengthen the domestic pharmaceutical supply chain. It also noted additional benefits, including enhanced communication through the review process and the maintenance of the FDA’s current safety and efficacy standards. It invited eligible companies to submit statements of interest (limited to 350 words) outlining the particular priorities that their drug development addressed.
Although the second announcement had included a five-voucher cap during the CNPV’s first year, the first nine recipients were announced on October 16, and include seven drug therapies and two proposals to increase domestic drug manufacturing. Therapies include:
- The recombinant gonadotropin Follitropin Alfa + Lutropin Alfa (Pergoveris), a fertility treatment produced by EMD Serono, a division of Merck KGaA;
- The anti-monoclonal antibody Teplizumab (Tzield), a treatment designed to delay the onset of stage 3 type 1 diabetes produced by Sanofi;
- The investigational oral nicotinic receptor agonist Cystisinicline designed to curb vaping addiction and related nicotine dependence produced by Achieve Life Sciences;
- The investigational genetic therapy DB-OTO produced by Regeneron, targeting a genetic mutation related to hearing loss; the recombinant human nerve growth factor Cenegermin-bkbj (Oxervate), targeting nerve regeneration produced by Dompé, who is investigating expanded uses to reverse or mitigate some forms of blindness;
- The pancreatic cancer therapy RMC-6236 showing antitumor activity produced by Revolution Medicines; and
- The investigational oral porphyria treatment Bipertin, produced by Disc Medicine.
The two remaining voucher recipients included Phlow’s proposal to incentivize domestic production of Ketamine and USAntibiotics’s proposal to incentivize domestic production of the antibiotic Amoxicillin and Clavulanate Potassium (Augmentin XR).
Although the CNPV is new, it has attracted a range of criticism from policy analysts. An October 3rd commentary from Brookings notes several potential problems with the program. First, the incentive offered by the CNPV—expedited review—does not neatly align with the program’s public health priorities. In particular, the benefit of expedited review is faster market entry and, at least potentially, reduced up-front capital costs related to standard longer-track review. However, the CNPV includes no mechanisms to promote increased domestic production or lower costs. Because of this, although initial statements of interest and meetings might include proposals for, e.g., onshoring, or discount programs, absent any tools of enforcement, these would be little more than proposals. Although estimates of the financial value of early market entry are potentially large, reasonable assumptions likely set an upper bound in the area of $70M, which would be insufficient capital to increase domestic production capacity.
Another concern relates to the potential conflict between the goals of maintaining rigorous review standards and drastically shortening the planned review duration. Prior to using the vouchers, companies would need to complete presubmissions, including the chemistry, manufacturing, and controls (“CMC”) submissions along with the labeling sections of the application at least 60 days prior to the start of the streamlined review. This amounts to a tacit acknowledgment that the process will require at least 90 to 120 days if every step runs according to plan. The program includes plans to prioritize drugs with complete applications, less complex reviews, and lower risk profiles. But it is unclear whether the agency, especially in light of recent workforce reductions, will be able to meet the administrative burden of accelerated review. The initially announced limit of five vouchers during the pilot stage was intended to address this limitation; the more aggressive release of nine initial vouchers may signal a higher than usual risk tolerance at the agency.
An October 25th Perspective in the New England Journal of Medicine extends these criticisms. While acknowledging that long review timelines have long been a bottleneck in the drug development process, the authors note that as of 2024, 66% of newly approved drugs qualified for at least one expedited review program, and 94% of approvals came within 10 months. Between the 1980s and the 2020s, median review times have gone down over 70%.
The authors note that unlike the other fast-track review programs, the CNPV was not legislatively authorized and included no agency budget appropriations to maintain the requisite personnel, effectively rendering it an unfunded mandate. The CNPV was initiated by the executive branch without going through the standard agency process of notice-and-comment, and similar to other Department of Health and Human Services (“HHS”) programs, the CNPV rules and selection criteria remain largely opaque. Its rollout, opacity and locus—directly under a political appointee, Commissioner Makary, could signal increased politization of the FDA’s drug approval process.
Criticisms notwithstanding, only time will tell whether the CNPV can deliver its advertised public health priorities without undermining the FDA’s effectiveness or trustworthiness.