When the Trump administration came into office at the beginning of 2025, it was clear that it had big plans for the healthcare industry. One of its goals was to change the regulatory landscape to allow for innovative new treatments to make it market faster while also promoting domestic manufacturing practices.

As a result, FDA launched the Commissioner’s National Priority Voucher program. Drugs entered in the program are awarded with an accelerated 30-to-60 day review window. However, they must also satisfy a set of criteria that is not judged equally for each drug.

The program has sparked a lot of discussion. Pharmaceutical Executive and its sister-publications spoke with several experts about the program and, most importantly, who will likely end up as the winners and losers.

Here are some of the most insightful quotes from our coverage:

Ryan Conrad
Visiting fellow
Center on Health Policy
Brookings Institution

A lot of the drugs awarded CNPV vouchers were already-approved drugs for new indications. Expanding indications is helpful on the payer side as it allows them to cover the drugs for a wider range of treatments.

The workload is potentially an issue since FDA lost some workers this year. While it wasn’t reviewers, workload is always an issue and if these reviews are taking up a lot of time and effort from other reviews, that’s not a good thing. Ultimately, I don’t think there will be a lot of losers.

Thani Jambulingam, PhD
Professor
Arrupe Center Research Fellow
Saint Joseph's University

With the first 15 CNPVs now awarded, we can begin to see a clear pattern: the winners weren’t just those with breakthrough science, but those with operational models ready for an accelerated, politically salient, affordability-linked regulatory environment.

The first two cohorts of voucher recipients, nine on October and six more in November, are not a random mix of assets. They reveal a clear bias in favor of companies that were operationally ready to move fast, willing to make explicit affordability and onshoring commitments, and already deeply engaged with the FDA.

One of the strongest signals embedded in the CNPV is support for U.S.-based manufacturing. This expectation is not symbolic; it is now a prerequisite for accelerated review.

Domestic production enhances resilience, reduces exposure to geopolitical risk, facilitates seamless inspection, and increases predictability in batch release. It also ensures the United States retains control over critical manufacturing capacity during public-health emergencies.

Companies are reconfiguring their supply chains accordingly, dual-sourcing APIs with at least one domestic supplier, securing U.S. fill-finish capacity, investing in modular and single-use manufacturing technologies, and building domestic capabilities for biologics, plasmids, and viral vectors.

John Kirk
Principal regulatory strategist
Veristat

To use a voucher for the short review period, sponsors must submit the CMC section of the marketing application at least 60 days before submitting the complete application. This means that manufacturing must be commercially ready sooner than necessary for a standard NDA. Also, clinical trials needed for the marketing application (or efficacy supplement) must be completed on time and be of high quality to facilitate review and pre-approval inspections. Finally, the short review period could result in information requests that must be addressed on very short notice. Otherwise, it is possible that FDA could request additional time to complete its review.

All these factors require strategic operational preparations to build the marketing application and be positioned to execute the review process in a tightly concatenated fashion. In our experience, sponsors who successfully navigate these compressed timelines integrate their biostatistics, regulatory, and medical writing teams from the outset, creating a unified approach where data flows seamlessly from analysis through narrative to submission, rather than treating these as sequential handoffs.

Ed Schoonveld
Value and access advisor
Schoonveld Advisory

Author
The Price of Global Health

Affordability is described as potentially cost lowering, but it's also describing offsetting medical treatments’ total healthcare costs. There are plenty of opportunities to find other offsets without just focusing on price cutting. For a company to develop a drug and then create a quick launch because of a price cut doesn't intuitively make a lot of sense.

How is FDA going to judge even a price cut? A company could say that they were going to price a drug at $5 million but instead decided to price it at $30,000. It's very hard to judge, so I'm not sure how they will go about that. What's concerning me a little bit is that it seems that FDA is encroaching in the price-setting cost evaluation domain. In Europe, we've seen the EMA do that many times, but its individual countries don't decree that the European organization is going to do that. While this one may not be that damaging, it could also be seen as a step for the FDA towards getting into that field.

Brad Stewart
National life sciences co leader
BDO

The National Priority Vouchers are an evolving opportunity for people. We don't clearly understand yet how the Commissioner's office is going to make the decisions on which drugs or for what reasons they award vouchers. It's clearly a great opportunity, and one of the stated priorities is helping to onshore manufacturing or improve domestic manufacturing for national security, for the interest the United States. There's certainly an opportunity there.

However, out of the vouchers that have been issued, most of them have not been for that reason. There's only been two that were specifically for manufacturing.