The FDA’s PreCheck Pilot Program And The New Marketing Mandate For Domestic Pharma Manufacturing
- Natalie Hussey
- Jul 12
- 8 min read
On June 29, 2026, the FDA selected seven companies for the first cohort of its PreCheck Pilot Program, a new initiative designed to support the development of domestic pharmaceutical manufacturing facilities.
The seven participants include Eli Lilly, Regeneron, Amneal Pharmaceuticals, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin. Together, their proposed facilities cover sterile medicines, biologics, cell and gene therapies, and other products tied to critical supply needs and unmet medical demand.
What is really telling is that the FDA received more than 80 participation requests during the one-month application window. The level of interest is just as important as the companies selected for the program. Two things are clear:
Pharmaceutical manufacturers see a serious strategic opportunity in domestic production.
Reshoring is about to become a crowded narrative space.
New American manufacturing facilities strengthen supply resilience, improve regulatory coordination, create jobs, reduce geographic exposure, and move production closer to the market. Those are meaningful advantages. However, these benefits are not a market position.
Building the facility is an operating strategy. Explaining why it matters to customers, partners, investors, policymakers, employees, and local communities is a commercial strategy. Companies need both strategies.
PreCheck Moves FDA Engagement Earlier
The FDA launched the PreCheck Pilot Program to make the development of new U.S. pharmaceutical manufacturing facilities more predictable. The program includes two phases:
The Facility Readiness Phase: Selected companies can engage with the FDA while facilities are still being designed, built, and prepared for operation.
The Application Submission Phase: FDA and participating manufacturers can address manufacturing information, assessments, and inspection issues connected to product applications.
The phases represent a notable change in timing. Historically, manufacturers have had to make expensive facility, equipment, and quality-system process decisions before receiving detailed regulatory feedback tied to an operating site. PreCheck allows selected companies to surface potential issues earlier, when design and implementation decisions may still be changed.
The commercial lesson is similar. Companies should not wait until a facility opens to determine how domestic production changes the market story. Messaging, customer education, stakeholder engagement, sales enablement, and reputation strategy should develop alongside the physical operation. Otherwise, the organization reaches a major milestone and communicates it with little more than a press release about square footage, capital investment, and projected jobs.
Domestic Manufacturing Is Not A Differentiator By Itself
FDA’s current reshoring push is rooted in legitimate supply-chain concerns. According to the agency, more than half of the pharmaceuticals distributed in the United States are manufactured overseas. As of 2025, approximately 53 percent of branded drug products and 69 percent of generic drug products were manufactured outside the country. Only 11 percent of active pharmaceutical ingredient manufacturers were based in the United States, compared with 22 percent in China and 44 percent in India. Those numbers create a compelling national policy argument for domestic investment.
However, the customer's argument is more specific. A hospital system does not purchase a drug solely because it was manufactured in the United States. A biotech sponsor does not choose a contract manufacturing partner only because the facility is domestic. A payer does not create favorable coverage because a company opened a plant in New Jersey or North Carolina. Each stakeholder still wants to know what the investment changes for them.
Your messaging needs to answer the following questions:
Does domestic production reduce lead times?
Does it create more reliable access during shortages?
Does it improve communication and technical support?
Does it reduce exposure to geopolitical disruptions?
Does it provide greater supply visibility?
Does it support faster scale-up?
Does it make quality oversight easier?
Does it provide additional manufacturing flexibility?
Does it reduce the likelihood that patients will experience treatment interruptions?
These are all market-facing benefits. They are stronger than a generic claim about bringing manufacturing back to America because they connect the facility to an operating or patient outcome.
The Commercial Story Depends On The Audience
One reason reshoring messages often remain vague is that companies try to tell one story to every stakeholder. The value of domestic manufacturing changes depending on who is listening:
Health systems may care about continuity of supply, shortage risk, contracting stability, and confidence in fulfillment.
Pharmaceutical and biotechnology partners may care about technical transfer, development timelines, access to capacity, regulatory coordination, intellectual property protection, and communication across manufacturing teams.
Investors may focus on capital efficiency, market demand, utilization rates, strategic control, operating margins, and the time required for the facility to generate revenue.
Regulators and policymakers may prioritize national resilience, critical-medicine capacity, product quality, supply-chain transparency, and reduced reliance on concentrated foreign sources.
Employees and local communities may care about skilled jobs, technical training, infrastructure investment, regional economic development, and the facility’s long-term commitment to the area.
These audiences are connected but not interchangeable. A strong market-education strategy establishes a single corporate position and then translates it into the language, evidence, and commercial priorities of each stakeholder.
The Market Needs More Than A Facility Announcement
Manufacturing announcements tend to follow a predictable formula. The company states the investment amount, location, facility size, expected production capacity, construction timeline, and number of jobs. Executives describe the project as an investment in innovation, resilience, patients, and the future.
The announcement describes the asset. However, it does not fully explain the strategy. A stronger narrative would show where the facility fits within the company’s broader manufacturing network, which supply constraints it addresses, what capabilities it adds, which customers or patient populations may benefit, and how the operation changes the company’s ability to respond to market demand. You need these explanations because most stakeholders cannot evaluate a manufacturing investment from technical specifications alone.
A flexible biologics facility may be strategically valuable because it supports multiple products, changing demand, or faster technology transfer. A sterile-fill operation may matter because shortages in injectable medicines can have immediate consequences for hospitals and patients. A cell-therapy facility may create value by reducing complex handoffs across collection, production, logistics, and treatment. The company has to make those connections explicit in its messaging.
Market Education Should Begin During Facility Development
A domestic facility may take years to bring into commercial operation. That period should not be treated as dead time from a marketing perspective because it is an opportunity to educate the market gradually. During development, the company can explain:
Why the facility is being built
Which industry problem does it address
What technical capabilities will it provide
How the operation supports the company’s long-term strategy
What milestones stakeholders should expect.
Marketing strategy for these messages includes:
Executive thought leadership
Technical explainers
Supply-chain content
Investor communications
Community engagement
Partner education
Conference presentations
Recruiting materials
Construction updates
Validation updates
The objective is to build an informed market before capacity becomes available. These activities are especially important for contract development and manufacturing organizations, advanced-therapy manufacturers, and companies entering new production categories. Their future customers may need to make sourcing, development, and capacity decisions well before a facility formally opens. A company that begins market development after commissioning may have already missed part of the buying cycle.
Resilience Claims Need Evidence
The word “resilience” appears in nearly every discussion of domestic pharmaceutical manufacturing. It is a useful language, but it can become meaningless when companies do not define it. Resilience may refer to:
Geographic diversification
Redundant capacity
Domestic sourcing
Safety stock
Shorter transportation routes
Flexible manufacturing systems
Better demand visibility
Multiple qualified suppliers
The ability to shift production between lines.
For example, a facility located in the United States may still rely heavily on foreign APIs, equipment, or suppliers. FDA’s PreCheck selection criteria explicitly prioritized facilities that use U.S.-manufactured finished dosage forms, drug substances, APIs, or key starting materials, while also considering projects that address critical products and supply vulnerabilities.
The source of input is a distinction that matters commercially. Companies should be precise about what they have actually localized and what risks remain in the broader supply chain. Sophisticated buyers will ask. A credible resilience story should specify:
Which supply-chain exposures does the facility reduce
Which materials or production stages remain internationally sourced
What redundancy or surge capacity does the operation create
How quickly can production respond to demand changes
Which critical products or therapeutic areas does the facility support
How the company will measure supply performance
General claims create awareness, but specific claims build buyer confidence.
Domestic Capacity Still Needs A Demand Strategy
The FDA’s selection process considered the products to be manufactured, manufacturing innovation, and market supply needs. Those are sensible criteria for a government pilot. However, a company still needs to answer a separate set of commercial questions.
Who will use the capacity?
How much demand already exists?
How much future demand depends on unapproved products?
What happens if market conditions change before the facility is operational?
Which customers should be secured during construction?
How will the company differentiate its capacity from other domestic projects?
What utilization rate does the business model require?
How will the sales team explain the economic value of the facility?
The volume of PreCheck applications suggests that domestic production will attract significant investment. It also means companies cannot assume that being early to reshoring will be enough. Several manufacturers may eventually make similar claims about resilience, advanced technology, and proximity to American patients. The commercial winners will be the companies that define a clearer reason to choose their capacity.
Manufacturing Innovation Needs Translation For The Market
PreCheck also prioritizes innovation in facility development and manufacturing operations. The FDA has indicated interest in facilities that could serve as replicable models, use innovative approaches, or strengthen the broader domestic manufacturing base.
Now this can create another communication challenge. Manufacturing leaders may understand the value of modular construction, automation, or replicable facility platforms. The market, on the other hand, may not.
A customer does not automatically understand why a modular facility improves access. An investor may not know how continuous manufacturing affects cost, quality, or scale. A community stakeholder may hear “automation” and assume the facility will create fewer jobs. Technical innovation needs to translate into business outcomes.
The useful story for the market is not that a facility uses advanced manufacturing. The useful story is that the technology may improve consistency, reduce waste, provide stronger process visibility, or make additional capacity easier to deploy. Manufacturing innovation needs to be shown as commercially relevant.
Sales Teams Need A Strong Manufacturing Narrative
Once the facility enters the market, the sales and business development teams will be responsible for turning the investment into revenue. So they need more than a corporate fact sheet.
They need to understand which customers face the greatest supply risk, which buyers place a premium on domestic production, and which objections will arise around pricing. They’ll also need to know how the facility compares with established international capacity and what evidence supports the company’s claims. Most importantly, they need a clear answer to a difficult question that will come up:
Why should the customer pay “more” for domestic manufacturing?
In some markets, domestic production will be more expensive. In those markets, the sales team must be prepared to discuss total value rather than unit cost alone. They need to highlight factors such as lower disruption risk, intellectual property considerations, or better alignment with customer sourcing policies. Without that framework, the company risks positioning domestic manufacturing as a patriotic premium rather than a sound business investment with a strong return.
Reshoring the Factory Is Only Half the Job
FDA’s PreCheck program signals that domestic pharmaceutical manufacturing is becoming a serious national and industry priority. The initial cohort, the more than 80 applications, and the agency’s broader manufacturing initiatives all point toward increased investment in U.S. capacity. Reshoring presents a very strong opportunity. It also raises the standard for how companies position themselves.
“Made in America” may attract attention, but it will not answer commercial questions. Buyers still need to understand how the facility improves quality, access, and speed. Companies should begin developing that story while they are developing the facility by:
Defining the audiences
Researching their priorities
Quantifying the value offered
Translating the technical capabilities into commercial value
Preparing the sales organization
Building market understanding before capacity comes online
As more companies invest in U.S. pharmaceutical production, the firms that communicate those advantages with precision will be better positioned to build demand, secure partnerships, and differentiate their capacity before it comes online.
Build the Market Story Alongside the Facility
Borrowed Pen helps manufacturers translate complex manufacturing investments into credible market narratives. We develop the research, positioning, and messaging needed to connect manufacturing capabilities to buyer value.
Building domestic capacity? Book a call and let’s give the market a reason to care.
Read More
U.S. Food and Drug Administration, “FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing”
U.S. Food and Drug Administration, “FDA PreCheck Pilot Program”
U.S. Food and Drug Administration, “FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing”
U.S. Food and Drug Administration, “FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing”
U.S. Food and Drug Administration, “FDA Actions to Support and Strengthen Domestic Drug Manufacturing”
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