ST. LOUIS, March 10, 2026 (GLOBE NEWSWIRE) — The API Innovation Center (APIIC), a nonprofit dedicated to strengthening national health security through U.S. generic pharmaceutical manufacturing and public-private collaboration, today released its 2026 White Paper, From Fragility to Resilience: Aligning Investment and Purchasing to Secure America’s Drug Supply Chain, outlining a policy roadmap to secure the domestic generic drug supply chain.
At a time when more than 200 prescription medicines are currently in shortage nationwide, the report highlights recurring shortages not as isolated disruptions but as symptoms of a structurally fragile supply chain. Limited supplier redundancy, concentrated global manufacturing and persistent underinvestment in domestic production have created systemic risks that leave patients vulnerable to care disruptions.
To move towards measurable resilience, the paper introduces APIIC’s National Fragility Index (NFI), a proposed framework designed to quantify supply chain risk and identify where vulnerabilities are most concentrated. By bringing measurable, risk-based metrics into purchasing decisions, the NFI aims to help policymakers and buyers better understand vulnerabilities across the supply chain.
“Resilience does not happen by accident,” said Tony Sardella, founder and chair of APIIC. “It must be incorporated into the system. When we align purchasing behavior with long-term investment and measure fragility before it becomes a crisis, we strengthen not only our supply chain, but our national health security.”
The report finds that many of the vulnerabilities stem from long-standing economic pressures in the generic drug market. For decades, generic drug procurement has largely prioritized price above all else. While this approach has lowered upfront costs, the relatively low return on investment for manufacturers has also discouraged long-term investment in domestic API production, contributing to offshoring, recurring shortages and supply fragility.
The white paper outlines several priority actions to address these structural challenges. Among them is urging federal agencies to act as first movers by incorporating quality and domestic sourcing considerations into purchasing practices. The report also recommends creating predictable demand through long-term purchasing commitments, guaranteed volume contracts and advance market commitments to de-risk private investment in U.S.-based API manufacturing and advanced manufacturing technologies.
The paper also highlights the critical role of public-private partnerships in rebuilding domestic pharmaceutical manufacturing capability. Through collaboration among government, industry and academic partners, APIIC is modernizing innovative manufacturing processes, activating underutilized U.S. production capability and developing critical APIs and other key components within the U.S.
“We can no longer define value in the generic drug market by price alone,” said Kevin Webb, president and COO of the API Innovation Center. “If we expect manufacturers to invest in domestic capacity and advanced manufacturing, the market must reward reliability, quality and supply security, not just the lowest cost.”
As policymakers, industry leaders and academic stakeholders continue to examine strategies for strengthening domestic generic pharmaceutical manufacturing, APIIC’s white paper provides a structured framework for moving from reactive responses to shortages toward a proactive approach to supply chain resilience. By elevating reliability and resilience alongside cost considerations, the organization argues that the United States can build a more secure and sustainable generic drug supply chain.
Click here to download and access the full white paper. To learn more about APIIC and its National Fragility Index, visit apicenter.org.
About the API Innovation Center:
The API Innovation Center is a 501(c)(3) nonprofit corporation and public benefit organization dedicated to strengthening U.S. health security by rebuilding domestic capability to develop and manufacture key starting materials and active pharmaceutical ingredients (APIs) for critical generic medicines. APIIC is leading the development of six clinically essential APIs and brings together government, industry and academia through public-private partnerships to modernize manufacturing and activate underutilized U.S. production capacity. Our work is supported by grants from the State of Missouri, the Missouri Department of Economic Development and a federal award from the Department of Health and Human Services’ Administration for Strategic Preparedness and Response. Visit apicenter.org to learn more.
