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Strengthening U.S. Essential Medicines Supply Chain Resilience
- Advanced Regenerative Manufacturing Institute (ARMI) | NextFab
Nexight partnered with ARMI | NextFab to develop the Essential Medicines Supply Chain and Manufacturing Resilience Assessment to prioritize medicines critical for acute patient care and outline industry-informed strategies to strengthen the resilience of the pharmaceutical supply chain.
The Challenge
How to Address Vulnerabilities in the U.S. Essential Medicines Supply Chain
The COVID-19 pandemic and several natural disasters exposed significant vulnerabilities in the U.S. pharmaceutical supply chain, particularly in ensuring consistent access to essential medicines for acute patient care. These vulnerabilities are exacerbated by economic pressures in the generic drug market, which limit both incentives for and the financial capacity of manufacturers to invest in redundancy and resilience. To improve preparedness and address these gaps, the White House issued Executive Order 14017, initiating a federal review of securing critical supply chains.
In response to the Executive Order, the U.S. Department of Health and Human Services (HHS), through the U.S. Administration for Strategic Preparedness and Response (ASPR), established a public-private initiative to strengthen domestic manufacturing and supply chain resilience for essential medicines. However, translating this mandate into action required addressing several complex challenges:
- Prioritizing the medicines most critical for acute patient care from the U.S. Food and Drug Administration’s Essential Medicines List
- Aligning clinical and industry stakeholders to develop practical, implementable strategies
- Navigating limited visibility into complex, global supply chains
Our Solution
An Industry-informed Approach to Strengthening Essential Medicines Supply Chain Resilience
To address these challenges, ARMI enlisted Nexight to develop a data-driven, stakeholder-informed assessment to prioritize the most critical medicines and identify strategies to strengthen supply chain resilience.
Stakeholder Engagement
Nexight engaged a broad, representative set of clinical and industry stakeholders to ground the assessment in real-world supply chain conditions and constraints.
- Conducted 40+ interviews (80+ stakeholders) across the supply chain
- Analyzed 80+ surveys and led four workshops (30–40 participants each) to validate and refine input
- Engaged clinical leaders nationwide to identify medicines most critical for acute patient care from the FDA Essential Medicines List
- Convened industry stakeholders to define practical, implementable strategies
- Conducted additional interviews with 28 manufacturers (60+ participants) to deepen insights on the most critical medicines
Analysis and Strategy Development
Nexight combined stakeholder input with rigorous research and data analysis to assess vulnerabilities and shape actionable strategies.
- Reviewed 100+ sources and analyzed proprietary supply chain data from the U.S. Pharmacopeia (USP), preparing over hundreds of graphs and other data visualizations
- Identified key risks and constraints affecting critical medicines
- Developed a prioritized set of strategies spanning supply chain coordination and transparency, domestic/nearshore production capacity, advanced manufacturing, and purchasing and distribution approaches
Nexight’s assessment has helped inform federal action and continues to shape national policy discussions and research on supply chain resilience, as biomanufacturing and access to essential medicines remain central to U.S. economic and national security priorities.
Impact
The Essential Medicines Supply Chain and Manufacturing Resilience Assessment and supporting non-public supply chain assessments have informed federal decision-making and shaped national policy discussions on essential medicine supply chain resilience, with findings cited by policymakers, researchers, and other leading institutions.
- Congress: Since its publication, the assessment has been cited in a report published by the U.S. Senate Committee on Homeland Security & Governmental Affairs, as well as in testimony before the U.S. House of Representatives Subcommittee on Oversight and Investigations of the Energy & Commerce Committee.
- Federal Government: The analysis helped inform CMS Medicare hospital inpatient prospective payment policy for Fiscal Year 2025 related to establishing and maintaining access to essential medicines. It was also cited in a 2024 white paper published by HHS’s Office of the Secretary.
- Think Tanks and Industry: The assessment was cited in the Council on Foreign Relations’ report, The Pharma Choke Point, and used to inform a supply chain intelligence company’s AI-driven analysis of the priority medicines identified in the report.
- Academic and Research Community: The assessment has also informed peer-reviewed research, including a landscape analysis published in the Journal of the American Pharmacists Association comparing the assessment’s priority essential medicines list with those from the U.S. Department of Defense, the FDA, and the World Health Organization.