On May 5, 2025, an executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines“ was signed by the administration. The order seeks to revitalize domestic pharmaceutical manufacturing by reducing regulatory barriers, decreasing reliance on international supply chains, and enhancing national security.
Key Provisions of the Executive Order
Streamlining FDA Approval Processes: The agency is directed to eliminate redundant requirements, expedite plant approvals, and collaborate with manufacturers before facilities become operational.
Enhancing Oversight of Foreign Manufacturers: The FDA is instructed to improve enforcement of active pharmaceutical ingredient (API) source reporting by foreign drug producers and consider publicly displaying a list of non-compliant facilities. To strengthen oversight, the FDA issued a press release announcing it will expand the use of unannounced foreign inspections to ensure consistent enforcement across global and domestic manufacturing sites.
Accelerating Facility Construction: The Environmental Protection Agency (EPA) is tasked with expediting the construction of facilities designed to manufacture prescription drugs, APIs, and other necessary raw materials. The executive order directs the EPA to update its regulations and guidance within 180 days to eliminate unnecessary red tape and make the review process for pharmaceutical manufacturing facilities faster and more predictable.
Coordinated Permitting Processes: Federal agencies issuing permits for domestic pharmaceutical manufacturing facilities are required to designate a single point of contact to coordinate applications, ensuring an efficient and coordinated process with support from the White House Office of Management and Budget. Additionally, the U.S. Army Corps of Engineers is tasked with reviewing existing nationwide permits to determine whether a new, activity-specific nationwide permit is necessary to further streamline the permitting process for pharmaceutical manufacturing facilities
These measures aim to bolster the U.S. pharmaceutical supply chain and reduce dependence on foreign sources for essential medicines.
Turning Trade Challenges into Strategic Opportunities
In Axendia’s article, “Turning Trade Challenges into Opportunities for Life Sciences” we discuss how the global life sciences industry has been navigating an “Age of Continuous Disruption,” characterized by natural disasters, geopolitical developments, and shifting trade policies. Most recently, tariffs have emerged as a significant factor affecting global trade, impacting the medical device and pharmaceutical sectors.
While tariffs can raise the cost of importing medical devices and pharmaceutical products, they also present opportunities to incentivize domestic production. Recent announcements underscore this momentum:
- Eli Lilly announced substantial investments in U.S.-based manufacturing facilities, aiming to reduce dependence on foreign supply chains and enhance resilience.
- Johnson & Johnson committed to investing over $55 billion in the United States over the next four years, including four new manufacturing sites, starting with a $2 billion biologics facility in North Carolina.
- Merck & Co. is investing $1 billion in a new 470,000-square-foot biologics manufacturing facility in Delaware.
These investments reflect a broader industry shift toward strengthening local supply chains and building manufacturing agility within the U.S. To successfully navigate these shifts, Axendia recommends companies adopt Smart Shoring strategies—strategically locating production facilities to optimize cost, logistics, and risk. By leveraging future-ready technology platforms and modern manufacturing execution systems (MES), organizations can build more flexible and resilient operations that are prepared for continued disruption and regulatory scrutiny.
Embracing a New Era of FDA Leadership
Life sciences companies must proactively adapt to a new FDA by enhancing data governance, investing in robust infrastructures, and fostering closer collaborations with regulators to expedite secure innovations.
In Axendia’s article, “The FDA’s New Chapter,” we noted the appointment of Dr. Marty Makary as the new FDA Commissioner will bring a unique perspective to the agency. His background as a surgical oncologist and advocate for transparency suggests a leadership style focused on patient safety, regulatory reform, and data-driven decision-making. His tenure is expected to influence the FDA’s priorities, potentially leading to more stringent data transparency requirements and streamlined approval processes for innovative therapies and digital health tools.
From Vision to Reality: Building the Factory of the Future, Today
The Factory of the Future is characterized by an operating model where quality, compliance, and performance are embedded across the entire value chain. It leverages digital twins, real-time analytics, predictive maintenance, and integrated Quality Management Systems (QMS) to ensure speed and reliability without compromising regulatory rigor.
Our research emphasizes the necessity for life sciences companies to transition from legacy, siloed systems to connected, intelligent, and compliant manufacturing environments. This vision underscored the importance of digital factories that support closed-loop manufacturing and workforce optimization across the product lifecycle.
With the recent executive order prioritizing domestic pharmaceutical production, this vision is more pertinent than ever. Building agile, automated, and digitally native facilities that prioritize quality is no longer a long-term aspiration. It is now a strategic necessity for national competitiveness and supply chain resilience.
Organizations that act now to modernize infrastructure and digitize operations will be better positioned to meet regulatory expectations, respond to global disruptions, and accelerate time to market. Many life sciences companies are focusing on upgrading legacy systems and retrofitting brownfield sites with modern technologies. This pragmatic approach allows manufacturers to enhance quality, ensure data integrity, and improve operational performance without the cost and delays of greenfield construction.
Companies that have proactively laid the groundwork for modernization are best positioned to respond to the call for domestic manufacturing. For these organizations, the Factory of the Future is not a distant concept but a present reality under construction.
Digital Transformation Starts in the Lab
While the executive order focuses on accelerating domestic pharmaceutical manufacturing, it’s important to recognize that production readiness begins long before a product reaches the shop floor. Embracing the future of laboratory operations is more urgent than ever.
Digitally transforming laboratory operations is a foundational step in building the resilient, quality-driven infrastructure needed to support reshoring efforts. By creating connected lab ecosystems that generate FAIR (Findable, Accessible, Interoperable, and Reusable) data, companies can improve product development cycles, strengthen data integrity, and accelerate tech transfer into commercial operations. These lab-based digital initiatives also support compliance and audit readiness which are critical capabilities as FDA oversight will be intensified under new leadership.
Investments in digital labs help ensure that domestic manufacturing facilities are not only built faster but operate with a high degree of quality and transparency from the start.
In Brief
The executive order represents a concerted effort to revitalize domestic pharmaceutical manufacturing by reducing regulatory barriers. However, the successful implementation of these initiatives will depend on effective collaboration between industry stakeholders and regulatory bodies. Embracing technological innovations within a clear regulatory framework will be crucial to achieving the goals set forth in the executive order.
As the life sciences industry continues to evolve, companies must build a culture of continuous innovation and improvement as it is the foundation for resilience in the age of continuous disruption.
By aligning strategic vision with agile execution, the industry can meet current challenges while unlocking new opportunities to strengthen the nation’s healthcare infrastructure and ensure long-term supply chain security.
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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.