HHS Releases Essential Medicines Supply Chain and Manufacturing Resilience Assessment
- As part of the Biden-Harris Administration’s work to revitalize American manufacturing and secure critical supply chains, the U.S. Department of Health and Human Services (HHS) established a public-private consortium for advanced manufacturing and onshoring of domestic essential medicines production.
- As part of the deliverables of the
100-day pharmaceutical supply chain report, the
National Forum to Secure America’s Supply Chain for Essential Medicines was tasked with (1) selecting 50-100 critical drugs, drawn from the Food and Drug Administration’s (FDA)
essential medicines list, to be the focus of an enhanced onshoring effort, and (2) developing strategies to overcome current pharmaceutical supply chain challenges and constraints.
- The Forum, including 183 leading subject matter experts, comprised clinical and industry stakeholder steering committees
that provided input and analysis via 80+ surveys, 40+ interviews, and 4 workshops.
- The Forum’s
clinical stakeholders included leading doctors, nurses, pharmacists, and public health experts from around the country, representing major hospital systems, professional societies, and government agencies providing direct patient care to underrepresented populations.
- The clinical stakeholders
prioritized 86 medicines as most critically needed for acute patient care, a subset of which were further identified for a thorough supply chain analysis.
- HHS is conducting supply chain analyses on these medicines to develop strategies to strengthen the resiliency of the supply chains for these medications.
- The Forum’s
industry stakeholders included experts from across the pharmaceutical supply chain – material suppliers, pharmaceutical manufacturers, group purchasing organizations, wholesale distributors – and thought leaders and innovators from the manufacturing sector.
- These industry stakeholders identified specific pharmaceutical supply chain and manufacturing constraints, characterized the biggest cross-cutting challenges impacting supply chain resilience, and developed strategies for achieving a robust pharmaceutical supply chain.
-
The Forum’s industry stakeholders identified
key solution strategies and specific implementation actions to achieve greater resiliency within the essential medicine supply chain, grouped into four categories:
- Increased Supply Chain Coordination, Security, and Transparency
- Expanded Onshore or Nearshore Production Capacity
- Advanced Manufacturing Capabilities and Innovation Research and Development
- Purchasing, Stockpiling, and Distribution Approaches
- The Forum elevated 8 solution strategies and 21 implementation actions as particularly high priority including: sustaining and increasing investment in platform technologies, incentivizing distributed manufacturing networks and leveraging public-private partnerships to create a shared data infrastructure/network to collectively respond to supply and demand challenges.
- Strengthening the United States’ ability to reliably manufacture and/or supply essential medicines when and where they are needed will enable a greater response to crisis- or market-based demand fluctuations to ensure economic and national security.
- Through investments in R&D and supply chain resilience, the Bipartisan Innovation Act will support the building and reshoring of domestic pharmaceutical manufacturing capacity to ensure that Americans have access to the essential medicines they need.
- To learn more, read the full Essential Medicines Supply Chain and Manufacturing Resilience Assessment.
Essential Medicines Fact Sheet
HHS Releases Essential Medicines Supply Chain and Manufacturing Resilience Assessment
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