. He can be reached at nsaraceno@mjhlifesciences.com.

Nicholas Saraceno, Editor

Is Faster FDA Review Enough to Justify Onshoring?

, 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.

Given the high cost of building or expanding US manufacturing capacity, do you think the shortened review time provides enough return on supply chain investment? Why or why not?

 Certainly, there’s definitely an incentive for people to think about their supply chains and how they can produce more of those products in the United States, whether they're the finished goods, it could be drug substance, drug product, or even people who are producing materials like single-use products we use in biomanufacturing. Part of that is, you're exactly right, Nico, the challenge of the timelines to onshore manufacturing, move it from one place to another are challenging.

But I think that if you look at what's changed over the last few years, two years ago, there was a big perceived risk, about doing manufacturing in China with the BIOSECURE act. A lot of times, companies, if they didn't change their manufacturing locations, they were deciding partnerships with CDMOs, those sorts of things they might have favored friendshoring, or near- shoring production in Europe or other places outside of China.

Now, that's even changed during this administration, where it's onshoring rather than those choices. I think the dynamic issues make that challenging, but certainly in the context of National Priority vouchers, that's one of the things they consider. We've seen a lot of those being issued for large-scale public health threats. There's one that was issued for vaping, tuberculosis was one. These applications are something the companies get to write themselves to create sort of that interest within the FDA.

I think there are companies that might have compelling drug candidates that can create a narrative which pulls all these together. Not only do I have something that's going to address a critical unmet need for healthy United States, I'm going to produce this in the United States for our patients. I think those are opportunities for people to stand out in the crowd.

Videos

In the second part of his Pharma Commerce video interview, Brad Stewart, BDO’s national life sciences co leader, reveals how National Priority Vouchers—and geopolitical pressure—are reshaping decisions around supply chain investment.

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and let’s get into today’s headlines.

First up, a look at an ongoing public health concern: Long COVID. A 

 highlights that patients are experiencing highly varying trajectories and, critically, that most continue to face symptoms long after their initial infection. While some see improvement, the persistence of issues like fatigue, cognitive dysfunction, and pain underscores the massive and evolving burden on both patients and the healthcare system. The findings stress the urgency for dedicated research to understand the underlying causes and develop targeted treatment strategies for this diverse and debilitating condition.

Switching gears to industry infrastructure, the US drug supply chain is getting a significant boost. Novartis has announced an 

 in North Carolina. This strategic move is poised to enhance the company's production capacity for key medicines, reinforcing the industry-wide push toward supply chain resilience. Bringing advanced manufacturing capabilities stateside is a crucial step in ensuring a stable and secure supply of essential drugs for patients in the US.

Lastly, in related news, Moderna is also doubling down on its domestic footprint. The company is 

 into a new clinical development and manufacturing facility in Marlborough, Massachusetts. This substantial investment further cements the trend of large-scale capital being directed into US-based biopharma innovation.

. For more insights on trends transforming pharmaceutical access and care delivery, visit 

Thanks for listening—until next time, stay well and stay informed.

Podcasts

While studies reveal the complex, varying, and long-lasting burden of Long COVID symptoms, biopharma giants Novartis and Moderna commit significant capital to new facilities, reinforcing US drug supply resilience in today’s Pharma Pulse.

Pharma Pulse: Long COVID's Enduring Challenge Amid Major US Manufacturing Surge

Image Credit: Adobe Stock Images/OleksKao.com

Novartis is growing its operations in North Carolina, with the production of a new flagship manufacturing hub that is expected to provide end-to-end manufacturing services.

 The commitment represents the Big Pharma company’s latest push in not only making sure that all of its drugs are produced domestically in the United States, but done so in an efficient manner.

The strategic investment—a component of the company’s greater mission to investment $23 billion over the next five years toward US infrastructure—is meant to serve as a way to fortify pharma’s US supply chain.

New facilities strengthen biologics, gene therapy, and solid dosage capabilities

Novartis’ latest moves in North Carolina will feature:

The construction of a new site in Durham, including two new facilities that’ll prioritize biologics production, along with sterile packaging

Growing the services of the current Durham plant—featuring gene therapy production as it stands—by expanding its services to include the sterile filling of biologics into syringes and vials

A Morrisville plant that will contain one facility for solid dosage tablet and capsule production, including packaging processes

A unified 700,000-square-foot manufacturing campus by 2027–2028

Together, the new and existing facilities will create a single hub, expanding capabilities to produce medicines across the company’s main therapeutic areas: oncology, immunology, neuroscience, and cardiovascular, renal, and metabolic. 

By integrating the new and future facilities, Novartis is aiming to establish one unified manufacturing hub that is expected to be ready for 2027-2028, totaling more than 700,000 square feet among the current and new facilities, simplifying yet enhancing the company’s ability to produce treatments across its main therapeutic areas, including cardiovascular, immunology, metabolic, neuroscience, oncology, and renal diseases. Having the plants be located close to one another will allow for the teams and production stages to operate more seamlessly.

The new investments are also anticipated create 700 new Novartis jobs, along with more than 3,000 indirect jobs across the supply chain by the end of the decade.

“This announcement is a commitment to American innovation and to the patients we serve,” said Vas Narasimhan, CEO of Novartis. “By building a full, end-to-end manufacturing presence in North Carolina for our broader portfolio, we are expanding our capacity to deliver medical breakthroughs, securing a more resilient US supply chain, and investing in the local communities that make our mission possible.”

Fast facts: Novartis’ new NC manufacturing hub

 Create a unified, 700,000-square-foot manufacturing hub supporting oncology, immunology, neuroscience, cardiovascular, renal, and metabolic therapies.

 Part of Novartis’ $23B commitment to US infrastructure over the next five years.

Broader US manufacturing strategy spans CGT, xRNA, and radioligand therapies

Currently, Novartis is now set up to manufacture various forms of tech in the US via:

CGTs that are produced in both Morris Plains, NJ, and Durham, NC

xRNA therapies to be manufactured at a new facility at a location that is TBD until announced in the near future

Radioligand therapies whose plants span from the East to West coasts, with plants located in Millburn, NJ, Indianapolis, IN, and Carlsbad, CA, along with two additional sites in the works for Florida and Texas

Novartis’ aforementioned Carlsbad plant spans 10,000 square feet and is intended to help the company prepare for future demand—as noted by the boost in capacity—enhancing its supply chain services in the process.

RLTs are a type of precision medicine that connect a tumor-targeting molecule—also known as a ligand, to a therapeutic radioisotope—which allows radiation to be delivered directly to cancer cells, while also limiting harm to any surrounding healthy tissue. Being that each RLT dose is custom-made and highly time-sensitive (its radioactive half-life is measured in only hours), proximity to treatment centers and transportation hubs are critical in order to ensure patients receive therapy both quickly and safely.

Onshoring momentum grows amid tariffs and supply chain pressures

Efforts to onshore manufacturing are continuing to become a bit more commonplace, as a way to combat tariffs that were enacted by the current administration.

This week, as a way to increased is drug product manufacturing in the US, Moderna announced

 a new $140 million investment in its onshore manufacturing that’ll bring its manufacturing capabilities to its Norwood, MA Moderna Technology Center (MTC), which is anticipated to be completed by H1 2027.

"By onshoring drug product manufacturing to our campus in Norwood, Massachusetts, we have completed the full manufacturing loop under one roof in the US," commented Stéphane Bancel, Moderna’s CEO. "As an American company committed to building and producing in America, we are proud to strengthen our domestic footprint while bringing meaningful new jobs to the community."

1. Novartis Announces Plans to Build Flagship Manufacturing Hub in North Carolina. Novartis. November 19, 2025. Accessed November 20, 2025. 

https://www.novartis.com/us-en/news/media-releases/novartis-announces-plans-build-flagship-manufacturing-hub-north-carolina

2. Saraceno N. Novartis Expands US Footprint With New Radioligand Therapy Manufacturing Facility in California. 

. November 12, 2025. Accessed November 20, 2025. 

https://www.pharmaceuticalcommerce.com/view/novartis-expands-us-footprint-new-radioligand-therapy-manufacturing-facility-california

3. Jacobus N. Moderna Investing $140 Million in Massachusetts Manufacturing Facility. 

. November 19, 2025. Accessed November 20, 2025. 

https://www.pharmexec.com/view/moderna-investing-140-million-massachusetts-manufacturing-facility

Articles

Novartis is expanding its operations in North Carolina with a new manufacturing hub, enhancing its US supply chain and creating 700 new jobs. This strategic investment is part of a $23 billion plan to bolster US infrastructure over five years. The facilities will focus on biologics, gene therapy, and solid dosage production, forming a unified 700,000-square-foot campus by 2027-2028. Novartis aims to strengthen its capabilities in oncology, immunology, neuroscience, and cardiovascular, renal, and metabolic diseases, while also advancing its manufacturing of CGT, xRNA, and radioligand therapies.

As part of its multi-billion-dollar investment, the company will be creating a unified, end-to-end manufacturing campus spanning biologics, gene therapy, solid dosage, and packaging operations.

Novartis Unveils Expansive North Carolina Manufacturing Hub to Strengthen US Drug Supply Chain

How CNPVs Could Reshape US Drug Manufacturing

What operational and financial challenges do manufacturers face when committing to on-shore production in order to qualify for a CNPV?

 The National Priority Vouchers are sort of 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.

So far out of the vouchers that have been issued, most of them have not been for that reason. There's only been two I can think of off the top of my head that were specifically for manufacturing. Those have been focused on pretty large-scale drugs to try and bring manufacturing back to the United States, or increase manufacturing in the United States. One was for an antibiotic, and the other is for an anesthetic.

I think, based on the data that's available now, the first is, do I have something like that? Is there a very large-volume product that's needed in the United States, where most of the supply comes from outside the United States? If you think back to the pandemic, the drugs that we really struggled to get here, that that may be the most immediate opportunity for manufacturers.

In the first part of his Pharma Commerce video interview, Brad Stewart, BDO’s national life sciences co leader, explains why large-volume, high-need drugs—especially those heavily sourced overseas—may be the strongest candidates, and how the pandemic’s supply chain lessons are influencing the program’s future direction.