Drug Supply Chain Resilience and Advanced Manufacturing Consortium

COVID-19 and other disruptions have highlighted the need for a more resilient drug supply chain. Manufacturing quality issues, natural disasters, bioterrorism, geopolitical issues, and other supply and demand shocks all pose threats to U.S. patients in need of life-saving essential drugs. Over 100 drugs are currently on the FDA drug shortage list, and adverse patient outcomes, including increased mortality rates and medication errors, are occurring too frequently.

The Consortium’s mission is 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. Based on input from a wide range of experts involved in manufacturing, distributing, purchasing, prescribing, and regulating prescription drugs, the Consortium will put forward written policy recommendations and other work products as necessary to advance these aims. We look forward to working together to build a drug supply chain that ensures patients access to safe and effective drugs, in adequate quantities, when they’re needed.

The Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium will consist of a group of experts in supply chain, manufacturing, regulatory science, national security, and drug shortages from academia, private industry, governmental agencies, and additional relevant stakeholder groups.

The Consortium operates on a membership model. All organizations are expected to contribute in-kind participation at the organizational level through routine public and private convenings as well as feedback on Consortium written products. Industry partners also contribute financial support as a condition of membership. The Consortium will advance its mission by convening members on a regular basis, conducting policy research, and developing recommendations for key private and public sector leaders.

Duke-Margolis will engage a consultative group composed of representatives from member organizations 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.

The Consortium will focus on these four workstreams in its effort to reduce the frequency and severity of drug shortages. Policy solutions in these four areas can help reduce drug shortages of both public health emergency response products and legacy products with chronic shortage issues. Duke-Margolis anticipates publishing a series of whitepapers with policy recommendations for policymakers and private and public sector drug supply chain stakeholders, informed by Consortium members’ comments and insights from workstream activities. 

COVID-19 and other recent supply chain disruptions have focused significant attention on vulnerabilities in U.S. drug supply chains. Shocks or disruptions on the supply or demand side can lead to significant shortages, and they have – over 100 drugs were on the FDA Drug Shortage List in 2022. Shortages can lead to billions of dollars in costs to the healthcare system, and more critically, worse outcomes, even mortality, for patients.

A resilient drug supply chain ensures patients have safe and effective drugs, in adequate quantities, when they’re needed. These “Four S’s” contribute to resilience: a supply chain with sufficient staff, stuff, space, and systems will be more resilient to supply- or demand-side disruptions.

Duke-Margolis Comment Letter to CMS on Buffer Stock Proposed Rule - September 2023

Advancing Federal Coordination to Address Drug Shortages - White Paper, September 2023

Duke-Margolis Comment Letter - Stop Drug Shortages Act - August 2023

Building a Resilient Drug Supply Chain Webinar - April 2021

Supporting Resilient Drug Supply Chains in the United States - Policy Brief, July 2021 

Duke-Margolis presents at Innovations in Pharmaceutical Manufacturing on the Horizon: A Virtual Dissemination Workshop - October 2021

PREVENT Pandemics Act Duke-Margolis Proposal Comments - February 2022

Duke-Margolis Drug Shortages Request for Information Comment Letter - July 2023

The Consortium will send out regular newsletters sharing our ongoing work and highlighting our members. If you would like to follow along with us, please subscribe to the newsletter here.