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Inside the FDA’s New Voucher Program: First 9 Picks Target Diabetes to Vaping
FDA launches the Commissioner’s National Priority Voucher program, expediting drug reviews for critical health needs.
The United States Food and Drug Administration (FDA) announced the first 9 voucher recipients under its new Commissioner’s National Priority Voucher (CNPV) pilot program, designed to accelerate review timelines for drugs and biologics that address major national priorities on October 16.1 The program aims to encourage innovation in areas such as unmet medical need, public health crises, domestic drug manufacturing, and medication affordability.
The FDA described the initiative as a modernization of the review process that combines expedited timelines with enhanced communication between sponsors and review teams. Under the CNPV pilot, recipients will receive a regulatory decision within 1–2 months of filing a complete application, along with increased interaction with FDA scientists during development and review. If necessary, the agency may extend review time in cases of incomplete submissions or manufacturing violations.
“The goal is to deliver more cures and meaningful treatments—especially ones that have an outsized impact on our most pressing national priorities,” said FDA Commissioner Marty Makary, MD, MPH, in a statement.1 “We must modernize the review process and try new approaches to meet the needs of the American people.”
"This drug would directly compete against a much more expensive option that currently has a monopoly in the American market, and this will bring down costs very significantly," President Donald Trump said about Pergoveris' voucher during the Improving Fertility Care and Expanding Access to IVF for Americans news conference also held on the 16th.1
The FDA noted that the new process reduces the traditional 10–12 month review timeline through a concurrent, team-based evaluation involving physicians and scientists. Once all review components are complete, applications will undergo a final “tumor board–style” meeting to ensure a comprehensive multidisciplinary assessment.
The agency expects to announce additional CNPV recipients in the coming months as it continues to refine and expand the program.
Each FDA drug review division nominated 1 product for inclusion in the CNPV program, with additional applications accepted through direct sponsor submissions. The first 9 recipients include:
Follitropin Alfa + Lutropin Alfa (Pergoveris)
Company: EMD Serono (Merck KGaA)
Indication: Infertility
Background Info:
Follitropin alfa + lutropin alfa is a recombinant gonadotropin approved in multiple countries for ovulation induction; its selection for the CNPV pilot reflects a strategic push to broaden access and lower costs of fertility therapies in the US.2
Teplizumab (Tzield)
Company: Sanofi
Indication: Type 1 Diabetes
A humanized anti-CD3 monoclonal antibody, teplizumab is FDA-approved to delay the onset of stage 3 type 1 diabetes in adults and children aged ≥8 years with stage 2 disease; its CNPV award underscores its potential to address a major unmet autoimmune disease.3
Cytisinicline
Company: Achieve Life Sciences
Indication: Nicotine/vaping dependence
Cytisinicline is an investigational oral nicotinic receptor partial agonist that has received FDA Breakthrough Therapy Designation for e-cigarette (vaping) and nicotine dependence; its CNPV selection aligns with efforts to curb the rising public-health burden of vaping.4
DB-OTO
Company: Regeneron
Indication: Deafness
An investigational gene therapy for OTOF mutation–related congenital hearing loss, DB-OTO has demonstrated meaningful hearing improvements in children and is now in phase 1/2 development; its CNPV designation reflects a major national priority in rare-disease gene therapy.5
Cenegermin-bkbj (Oxervate)
Company: Dompé
Indication: Blindness
Cenegermin-bkbj is a recombinant human nerve growth factor approved for neurotrophic keratitis; though its current use addresses a rare ocular disease, its CNPV award signals broader potential in regenerative ophthalmology and prioritized therapies.6
RMC-6236
Company:
Indication: Pancreatic cancer
RMC-6236 is a novel orally-active RAS(ON) inhibitor in phase 3 for metastatic pancreatic ductal adenocarcinoma; early data show antitumor activity and acceptable safety, making it a high-priority candidate under the CNPV scheme.7
Bitopertin
Company: Disc Medicine
Indication: Porphyria
Bitopertin is an investigational oral glycine transporter 1 inhibitor targeting erythropoietic protoporphyria and X-linked protoporphyria; although a phase 2 study met the primary biomarker endpoint and missed a secondary, its CNPV selection points to unmet need in rare metabolic disorders.8
Ketamine
Company: Phlow
Indication: Domestic manufacturing of anesthetic
Ketamine, a decades-old anesthetic agent and Schedule III substance, has been awarded a CNPV to incentivize US domestic manufacturing of this essential medicine, not specific to a new indication but to strengthen critical drug supply security.9
Amoxicillin and Clavulanate Potassium (Augmentin XR)
Company: USAntibiotics
Indication: Domestic manufacturing of antibiotic
Augmentin XR is an FDA-approved extended-release combination antibiotic used to treat community-acquired pneumonia and acute bacterial sinusitis. The drug is produced by USAntibiotics at its Bristol, Tennessee facility—the nation’s only remaining source of US-made amoxicillin products—and received a voucher to encourage domestic manufacturing of critical antibiotics.10
