The Unwritten Requirement for CNPVs

In a recent discussion with Pharmaceutical Commerce, Brad Stewart, BDO’s national life sciences co-leader, dives into the role of the Commissioner’s National Priority Vouchers (CNPVs)—a program designed to incentivize pharmaceutical activities that support US national interests, including domestic manufacturing. The industry is still waiting to see how the FDA Commissioner’s office will determine which drugs or manufacturers qualify for these vouchers, as the decision-making framework has not yet been fully clarified. Although CNPVs are widely viewed as a valuable opportunity, the criteria for selection remain somewhat opaque.

One of the program’s stated goals is to bolster domestic drug production, particularly for products considered essential for national security or for strengthening the US healthcare supply chain. However, Stewart notes that most CNPVs issued to date have not been tied directly to manufacturing-related reasons. Only two vouchers so far have been awarded specifically for domestic production, each aimed at bringing large-volume, medically important drugs back to US manufacturing sites. These cases involved one antibiotic and one anesthetic—both categories of drugs that the US has historically struggled to maintain stable access to, especially during global disruptions.

Stewart highlights that the strongest candidates for future CNPVs may be high-volume products critical to the US healthcare system where the majority of supply is currently sourced internationally. He points to lessons learned during the COVID-19 pandemic, when the nation faced acute shortages of several foundational medicines. Drugs that demonstrated vulnerability in supply during that time—particularly those with heavy overseas reliance—could represent the most immediate opportunities for manufacturers seeking to qualify for an NPV.

Overall, while the pathway to securing a voucher is not yet firmly established, Stewart emphasizes that companies with essential, widely used drugs and a compelling case for onshoring production may be best positioned as the program’s direction becomes clearer.

He also shares whether he believes the shortened review times offers enough return on supply chain investment; the definition of manufacturing commitment; how to measure the long-term value of CNPV; and much more.

A transcript of his conversation with PC can be found below.

PC: What level of manufacturing commitment do you believe is necessary for a CNPV applicant to meaningfully improve US supply chain resilience?

Stewart: Great question—the answer doesn't exist. I think that's one of the challenges. Currently, these have come through a couple of different ways. You can submit an application and sort of describe how you're going to meet the Commissioner’s priorities, one of which is supply chain resiliency and onshoring manufacturing. More of the designations, or the voucher designations that have been received so far have been related to unique drugs or treatments, or secondary indications for existing treatments. I think that will evolve.

You know, Flow received a voucher for producing ketamine, which is in short supply in the United States. I think that there are, like I said, some large volume products people have near-term opportunities. For particularly areas like oncology, which is always an area where there are a large number of diseases or types of cancer which don't have effective treatments, certainly that's an opportunity for people who have unique therapies, or for rare diseases to make the effort to also onshore manufacturing for those drugs, which might help take their applications and move them closer to the top of the pile for selection.