Duke-Margolis Launches Drug Supply Chain Resilience and Advanced Manufacturing Consortium

For Immediate Release

March 29, 2023

Duke-Margolis Launches Drug Supply Chain Resilience and Advanced Manufacturing Consortium

Diverse Stakeholders to Tackle Major Challenges to Drug Supply Reliability

Washington, DC—The Duke-Margolis Center for Health Policy has launched a new consortium to identify effective policy solutions that promote a resilient drug supply chain with advanced manufacturing capabilities and, ultimately, reduce the frequency and severity of drug shortages. The consortium’s growing membership includes experts in supply chain, manufacturing, regulatory science, national security, and drug shortages from academia, private industry, governmental agencies (as observers), and additional relevant stakeholder groups. The consortium will continue to add new members in the coming months.

“There is both greater need and more opportunity than ever to address longstanding challenges in medication supply chains and manufacturing,” said Mark McClellan, director of Duke-Margolis. “The Duke-Margolis consortium is bringing together stakeholders and policy expertise to meet the moment, and improve the reliability and affordability of our medications.”

Manufacturing quality issues, public health emergencies, natural disasters, bioterrorism, geopolitical issues, and other supply and demand shocks all pose threats to patients in need of life-saving essential drugs. Over 100 drugs are currently on the FDA drug shortage list. Drug shortages cause delays and disruptions to essential patient care, more medication errors, and in some cases, higher mortality rates. Working to locate scarce medications, or find alternative therapies for patients, places even more burden on an already strained health care workforce. And, severe drug shortages can cost the health care system billions in added costs.

“Medicine quality issues routinely threaten supply chain resilience. Further, medicines supply chain disruptions and vulnerabilities often lead to medicines quality issues,” said Ronald T. Piervincenzi, Ph.D., CEO of US Pharmacopeia (USP). “USP is pleased to join the Duke-Margolis Consortium to reduce barriers to the adoption of advanced manufacturing technology, as another step advancing our medicines supply chain resilience portfolio.”

Duke-Margolis will engage members from the Consortium around the following four workstreams:

supporting a coordinated and sustained federal effort to promote drug supply chain resilience and advanced manufacturing;
proposing measurement and tracking mechanisms for drug supply chain resilience;
exploring additional policy and practical approaches to improve drug supply chain resilience; and
promoting the increased adoption of advanced manufacturing technologies.

Policy solutions in these four areas can help reduce drug shortages of both public health emergency response products and established products with chronic shortage issues. Duke-Margolis anticipates creating a series of whitepapers, convenings, and other research and publications with policy recommendations for public and private sector drug supply chain decision-makers, informed by Consortium members’ comments and insights from workstream activities.

Drug Supply Chain Resilience and Advanced Manufacturing Consortium Founding Members:

AARP
AmerisourceBergen
API Innovation Center
Curae Pharma360
Eli Lilly and Company
Healthcare Distribution Alliance (HDA)
Healthcare Supply Chain Association (HSCA)
Lachman Consultant Services, Inc.
National Institute for Pharmaceutical Technology and Education (NIPTE)
US Pharmacopeia (USP)

Government Observers:

ASPE | Office of the Assistant Secretary for Planning and Evaluation
ASPR | Administration for Strategic Preparedness and Response
FDA | Center for Biologics Evaluation and Research (CBER)
FDA | Center for Drug Evaluation and Research (CDER)
FDA | Office of Counterterrorism and Emerging Threats (OCET)

For additional membership information, please visit the Supply Chain Consortium web page or email, Thomas.roades@duke.edu.

###

Contact: Patricia Green, Duke-Margolis

Patricia.s.green@duke.edu, 301.520.6482

About Duke-Margolis

The mission of the Robert J. Margolis, MD, Center for Health Policy at Duke University is to improve health, health equity, and the value of health care through practical, innovative, and evidence-based policy solutions. For more information, visit healthpolicy.duke.edu and follow us on Twitter @DukeMargolis.