In November 2025, the FDA released the second batch of recipients under its new National Priority Voucher (NPV) program, a fast-track review pathway intended to speed up medicines tied to US national priorities. According to Commissioner Marty Makary in the press release, the initiative is meant to pioneer “new ways of bringing cures and meaningful treatments to market faster” by convening rapid expert reviews that span clinical, manufacturing, and labeling disciplines.
The latest list features six products spanning oncology, metabolic disease, and global health priorities. They include zongertinib for HER2-positive lung cancer, dostarlimab for rectal cancer, orforglipron and Wegovy for obesity and related conditions, and bedaquiline for drug-resistant tuberculosis in young children, alongside Casgevy gene therapy for sickle cell disease.
Several of the therapies carry significant public health implications, from safety monitoring and resistance risk to the infrastructure and access challenges associated with advanced genetic treatments. Their selection for this new process raises important questions about how the FDA will balance speed and accessibility with the need to safeguard patient safety.
This story is the first in a series exploring the National Priority Voucher program, with upcoming articles examining each therapy in detail, including potential impact, safety considerations, and what accelerated review means for patients both in the US and globally.
Months instead of years
The NPV program, launched in June 2025, promises to compress the typical 10- to 12-month review window into one to two months for qualifying applications. Companies that receive a voucher commit to one or more requirements:
- Addressing a health crisis in the US
- Delivering more innovative cures for the American people
- Addressing unmet public health needs
- Increasing domestic drug manufacturing as a national security issue
- Increasing affordability
The FDA says the accelerated timeline will be enabled by one-day multidisciplinary expert meetings — a model inspired by oncology tumor boards, where specialists convene to reach decisions quickly.
This process is already underway, with the first approval under the program granted on December 10th to Augmentin XR, a US-made formulation of the widely used antibiotic combination amoxicillin and clavulanate potassium. Originally developed by GSK and approved by the FDA in 2002, the new authorization moves production to a domestic facility, aiming to strengthen supply chains and address antibiotic shortages in the US. The review was completed in just two months, proving that the NPV program can drastically accelerate regulatory timelines.
If there are no intentions of increasing or reallocating FDA resources, there is a possibility that these timelines will come at the expense of other programs. Reviewers will still be expected to uphold rigorous scientific standards, but under these compressed timelines. This could unintentionally delay or deprioritise rare disease programs, novel mechanisms, or submissions from smaller companies.
– Richard Tree, Project Farma
The NPV program is not just speeding initial approval; it’s also accelerating new formulations, age expansions, and additional indications. Anshul Mangal, CEO at Project Farma, told DDN, “In some cases, the voucher may help sponsors move more quickly toward expanded indications or new patient populations. Reducing the review times for these programs could bring those updates to patients sooner. While patients may gain access to these updates sooner, the compressed timelines can ultimately limit the depth of regulatory and scientific dialogue put in place for patient safety.”
Richard Tree, President at Project Farma, agreed that this could also put a lot of strain on FDA resources, “If there are no intentions of increasing or reallocating FDA resources, there is a possibility that these timelines will come at the expense of other programs. Reviewers will still be expected to uphold rigorous scientific standards, but under these compressed timelines. This could unintentionally delay or deprioritise rare disease programs, novel mechanisms, or submissions from smaller companies.”
Does a faster review mean greater safety risk?
Academic research consistently suggests that dramatically shortened review times — particularly those under 180 days — are correlated with higher rates of post-approval safety events. Under NPV, the target window is just 30–60 days, a pace unprecedented for gene-editing therapies, complex manufacturing processes, or those with significant safety risks.
A New England Journal of Medicine perspective on the NPV program notes that while the program is designed to address supply-chain vulnerabilities and chronic-disease burdens, it remains largely untested. Compressing regulatory scrutiny into such a short window could increase pressure on FDA reviewers and heighten the risk that safety issues slip through. As more vouchers are awarded, the FDA will face growing pressure to prove that rapid reviews can deliver both speed and safety.
If companies believe that pricing concessions and policy alignment incentives can get expedited reviews for products that are already profitable, it may shift focus towards these resources and away from early innovation. There could be a potential shift in R&D focus towards commercial optimization rather than scientific advancement.
- Anshul Mangal, Project Farma
Since most of the products chosen for vouchers in the second batch have already undergone full FDA approval, it begs the question: Is there anything to worry about? Shelley Preslar, Vice President of Client Solutions at Project Farma, explained, “With these already approved drugs, companies could be submitting anything from new clinical data, post-market safety information, biomarker-based claims, or new manufacturing methods. This extremely truncated timeline leaves less time for iterative questions or a deep dive into manufacturing risks. It also reduces opportunities to explore unexpected safety signals and subgroup findings. With fewer review cycles to fully analyze the data, there’s a greater risk that subtle safety patterns or inconsistencies could be missed.”
On the upside, faster review of label expansions or new age groups could provide meaningful benefits for patients with few treatment options. However, Mangal warned: “If companies believe that pricing concessions and policy alignment incentives can get expedited reviews for products that are already profitable, it may shift focus towards these resources and away from early innovation. There could be a potential shift in R&D focus towards commercial optimization rather than scientific advancement.”
