In June 2025, the US Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) pilot programme.
The regulatory framework allows biotechs and pharma companies who receive a voucher to have a shortened FDA review time for a new drug application of up two months, down from the usual 10-12 month timeframe. This is approximately four months shorter than review periods under existing frameworks, such as the rare paediatric priority review voucher (PRV) programme.
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While the CNPV programme shares elements with existing PRV schemes, the eligibility criteria is different. Companies must demonstrate US-focused potential, such as addressing a health crisis in the country, providing an innovative cure for US patients, meeting public health needs or increasing domestic drug manufacturing as a national security issue. Affordability was added as an additional consideration later in the pilot program.
The effects of the CNPV program on US drug development and approval processes are still being assessed.
Big pharma represents awardees
In October, the FDA announced the first batch of nine recipients of a voucher under the CNPV scheme. This included large companies such as Sanofi and Regeneron, and biotechs like Revolution Medicines. FDA commissioner Marty Makary stated that the selection process was primarily driven by reviewers, not applications. Of these first nine recipients, five companies actively applied, while four were nominated by FDA drug review divisions.
The second batch of recipients, announced in November 2025, included six companies, five of which are recognised as large pharmaceutical companies. The list, which included Eli Lilly, Johnson & Johnson (J&J), and Novo Nordisk, amongst others, all have pricing agreements with the White House.
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By GlobalDataIn December 2025, The FDA proactively awarded a voucher to J&J for a combination of Tecvayli/Darzalex in relapsed/refractory multiple myeloma. Makary said: “When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly.” In this instance, the FDA awarded a voucher to another big pharma company with an existing pricing agreement.
In the same month, MSD won a pair of vouchers for two cancer candidates. It brought the total number of products awarded a voucher to 18.
Elizabeth Mulkey, partner at law firm Goodwin, says: “While it’s certainly not a prerequisite to have some sort of formal pricing agreement in place, one thing that’s been interesting to see is that most of the recipients thus far, numerically, have been bigger pharma companies.”
Opacity on award process
As per the FDA, companies must demonstrate eligibility when applying for a voucher. Applicants submit a statement of interest in which they describe how their drug development programmes align with a selected national health priority. This must be done in 350 words or fewer.
However, many vouches have been proactively awarded, which was not originally outlined when the scheme was unveiled.
A former FDA reviewer tells Pharmaceutical Technology that internal nominations may favour drugs that can meet a shorter timeline.
“If you’re an FDA reviewer, you’re likely not going to nominate a high-profile drug that is first-in-class because you can’t get that work done in two months. You’re already self-selecting for easy, low hanging fruit,” says the source, who worked at the FDA Center for Biologics Evaluation and Research (CBER) for 27 years.
Apart from J&J’s case, it is currently unclear when a voucher was awarded in response to an applicant versus proactive nominations by the FDA.
In a statement to Pharmaceutical Technology, an FDA spokesperson said: “Internal nominations are made by FDA scientific experts such as reviewers, review divisions, or Center leadership. The route through which a voucher is awarded does not impact the review process or approval standards.”
The reasons for the centre’s leadership involvement have not been specified; historically they have not participated in selecting recipients for expedited regulatory programmes.
What it does show, according to Mulkey, is where FDA leadership priorities lie in public health.
“The FDA reaching out to companies in response to drug data is something that will be interesting to watch. This can give an insight into the indications or patient populations that the FDA is prioritising internally,” Mulkey comments.
The most common therapy area in the tranche of vouchers is oncology, though this includes both drugs from both applications and proactive allocations.
A scheme beyond the FDA’s remit
Via it’s directives, the scheme resonates with wider goals set by the Trump administration to bolster the US pharma landscape. Several major drugmakers have invested billions of dollars in domestic manufacturing as part of an onshoring initiative to decrease reliance on medicine imports.
While the FDA’s remit falls under Health and Human Services secretary Robert F Kennedy (RFK) Jr, the CNPV scheme is an agency framework that directly incentivises drug development for the US market.
According to the ex-FDA reviewer, the scheme’s directives do not align with the FDA’s role.
“Encouraging onshoring of manufacturing is not a reason to grant any kind of FDA judgement or approval. The agency’s role is to approve safe and effective treatments, not get involved with national security issues, supply chains or medicine pricing.”
The CNPV list includes products such as general anasthesia and pergoveris for infertility, which are not widely cited as national health emergencies in the US, according to public health experts.
“Affordability became the real reason, not infertility, for example. It’s a strange indication to take as your national priority. There are unusual categorisations and interpretations. Overall, there are subjective categorisations to get to the voucher,” the ex-FDA reviewer says.
A brief statement of interest
Medicus Pharma is one of the many companies seeking a voucher. The biotech is developing a non-invasive treatment for basal cell carcinoma, which is the most common cancer in the US. Medicus’ CEO believes it is treating a national emergency, qualifying the company for a voucher.
Pharmaceutical Technology has seen the 350-word statement Medicus sent to the FDA. It describes the product, why it aligns with national priorities, and the ongoing clinical programme.
“The 350 words that we have written, the initial reaction is that it’s very little,” says Medicus CEO Raza Bokhari.
“But it’s there to make applying easier. From socialising informally with high ups at the FDA, the thought is that, through this portal, a lot of people can apply. The FDA can swiftly narrow down the ones of interest and ignore others. As a triage concept, I think the 350 words is plenty.”
But such a relatively easy application method means volumes of those seeking a voucher soared. It is one of the reasons why the FDA started to tap internal resources and proactively award vouchers.
What Bokhari does ask for, however, is more communication from the FDA to applicants waiting to hear if they have been successful.
“We will stay in the queue and see where it goes. I think regular updates would be a good thing, other than just an acknowledgement that the FDA’s received the application,” he says.
Future amid regulatory delays
The past year has seen significant changes at the FDA. Since RFK Jr assumed his role as Health and Human Services secretary, he has implemented notable health policy shifts, most notably in vaccines. This has coincided with several leadership changes at the FDA due to previous incumbents departing due to differences with the new direction. Additionally, the workforce was reduced, as part of a White House initiative to streamline government agencies.
Industry leaders are monitoring whether the FDA, following a period of staffing changes, will be able to meet the shortened review timelines under the CNPV framework.
Big players have been hitting hurdles already on the scheme. As per Reuters, Sanofi, Disc Medicine, and Eli Lilly have all been hit with FDA delays, despite their respective drugs being on the CNPV list.
The overall efficiency of the new voucher framework is yet to be determined.
