FDA's Support for Onshoring Drug Manufacturing and Increasing Oversight of Foreign Facilities

Since 2000, pharmaceutical manufacturing has increasingly moved offshore. Today, approximately 53% of brand drug products and 69% of generics have at least one manufacturer outside the United States. Additionally, the United States relies on foreign sources even more so when it comes to drug substances, with only 9% of API (Type II) DMF holders in the United States, whereas 22% are in China and 44% in India.[i] The administration views this increasing reliance on foreign sources for U.S. medicines and medical products as a national security concern. Accordingly, in 2025, President Trump and FDA have made a number of announcements aimed at bolstering domestic manufacturing (or onshoring) of drugs and biological products while tightening oversight of foreign facilities.

Building upon his first-term efforts to onshore essential medicines, President Trump issued EO 14293, which directs the Environmental Protection Agency ("EPA") and FDA to reduce regulatory barriers to building and expanding pharmaceutical manufacturing capacity in the United States and improve the predictability of their reviews. The order also promotes an "America First" agenda, seeking to address the more frequent and rigorous inspections at domestic facilities relative to their foreign counterparts and calling for higher fees and more frequent inspections of foreign manufacturing plants. 

In response to that EO, FDA created the FDA PreCheck Program, which is designed to streamline the process for building new domestic pharmaceutical manufacturing facilities through early and collaborative engagement between FDA and manufacturers. FDA also announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities producing medicines, food, and other medical products for the U.S. market to ensure they face the same level of scrutiny as domestic ones. 

Commissioner Makary also doubled down on his efforts to promote the "America First" agenda with his new Commissioner's CNPV pilot program, which is expected to reduce application review time for certain drugs and biologic products to one to two months by utilizing a cross-disciplinary "tumor board style" meeting approach following a sponsor's final application submission. Eligibility for a CNPV involves demonstrating alignment with one or more of the program priorities, which include "onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency" and "increasing affordability … [which] could include a company that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation pricing." 

FDA Shifting Toward More Pervasive and Continuous Oversight 

Notwithstanding the recent developments in support of "America First" manufacturing and innovation, FDA has also made a number of additional changes signaling an intent to bolster its regulatory compliance and enforcement efforts: 

• Using Elsa (FDA's GenAI tool) to "identify high-priority inspection targets"; 
• Finalizing guidance on Remote Regulatory Assessments;
• Increasing the number of for-cause inspections by 250% in 2025; and 
• Reorganizing FDA's inspectorate "to better support the anticipated increases in domestic manufacturing that the Trump Administration has been pushing." 

These changes suggest a shift in FDA's approach toward more proactive, pervasive, and continuous oversight. 

With the administration's priorities to onshore drug manufacturing and lower drug prices, some companies may be considering utilizing a contract drug manufacturing organization ("CDMO") to assist with onshoring their manufacturing operations as a cost-saving measure. In FDA's new era of "anytime, anywhere" inspections and AI-powered "real-time" regulatory oversight, it will be even more important for companies to have robust quality and operational oversight—including at their CDMOs and other contracted facilities. Companies should also evaluate their quality management systems and consider enhancements by strategically building a data-centric quality culture, including with their CDMO partners, aimed toward achieving a continuous state of verifiable compliance and ever-readiness.