Duke-Margolis ReVAMP Drug Supply Chain Consortium

About the Consortium

Problem Statement: 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.

Mission of the ReVAMP Drug Supply Chain Consortium: The Consortium’s mission is to generate effective policy solutions that promote a reliable drug supply chain with advanced manufacturing capabilities and, ultimately, to improve patient outcomes by reducing 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.

Consortium Composition and Participation: The Duke-Margolis ReVAMP Drug Supply Chain Consortium consists 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’s mission is to generate effective policy solutions that promote a reliable drug supply chain with advanced manufacturing capabilities and, ultimately, to improve patient outcomes by reducing the frequency and severity of drug shortages.

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.

Consortium Workstreams

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 reliability and advanced manufacturing;

● Proposing measurement and tracking mechanisms for drug supply chain reliability;

● Exploring additional policy and practical approaches to improve drug supply chain reliability; 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 publishes whitepapers, issue briefs, and other publications with policy recommendations for policymakers and private and public sector drug supply chain stakeholders, informed by Consortium members’ comments and insights from workstream activities.

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

Recent Consortium Work: Duke-Margolis Comments and Recommendations to House Ways and Means Committee Regarding Chronic Drug Shortages - Comment Letter, February 2024

Demand-Side Reforms To Prevent Drug Shortages: Medicare’s Role In A Successful National Strategy - Journal Article, Health Affairs, January 2024

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

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

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

Addressing Drug Shortages Through Quality Management Maturity and Supply Chain Reliability Programs - Issue Brief, December 2023

Demand-Side Reforms To Prevent Drug Shortages: Medicare’s Role In A Successful National Strategy - Article, January 2024

Considerations for FDA's New Advanced Pharmaceutical Manufacturing Programs - Issue Brief, March 2024

Related Duke-Margolis Research: 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

Duke-Margolis Comment Letter to the U.S. House of Representatives Ways and Means Committee on Policy Solutions for Chronic Drug Shortages - February 2024

Join the Consortium's Newsletter: 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.

ReVAMP Drug Supply Chain Consortium Members

Advisory Group

Laura Bray Chief Change Maker Angels for Change	Michele Mestrinaro Global Head of Policy Novartis
Janine Burkett President, Strategic Global Sourcing AmerisourceBergen	Fernando Muzzio Immediate Past Chair, Faculty Committee National Institute for Pharmaceutical Technology and Education
Amy Cadwallader Director, Regulatory and Public Policy Development and Quality Institute US Pharmacopeia	Leigh Purvis Senior Director, Health Care Costs and Access AARP
Rena Conti Dean’s Research Scholar and Associate Professor, Markets, Public Policy, and Law Boston University Questrom School of Business	Anthony Sardella President and CEO API Innovation Center
Patrick Day Principal Consultant Lachman Consultant Services, Inc.	Stephen Schondelmeyer Professor and Director, PRIME Institute, Department of Pharmaceutical Care and Health Systems University of Minnesota
Todd Ebert President and CEO Healthcare Supply Chain Association	Stephen Stalker Vice President, Drug Shortages, Pharmaceutical Solutions and Services Generics McKesson
Mark Godfrey Senior Director, Global Public Policy Eli Lilly and Company	David Thompson Professor, Department of Chemistry Purdue University
John Gray Dean’s Distinguished Professor, Department of Operations and Business Analytics, Fisher College of Business Ohio State University	Cecilia Tami Head PTR U.S. Policy Genentech, Inc.
Frank Gupton Floyd D. Gottwald, Jr. Chair in Pharmaceutical Engineering Virginia Commonwealth University	Eric Tichy Division Chair, Pharmacy Supply Solutions; Associate Professor of Pharmacy Mayo Clinic
Diane Hustead Chair, Drug Shortage Initiative Team International Society for Pharmaceutical Engineering	Terri Lyle Wilson Vice President of Pharmacy Children's Hospital Association
Nicolette Louissaint Senior Vice President, Policy and Strategic Planning Healthcare Distribution Alliance

Observers

Trinidad Beleche Senior Economist, Office of Science and Data Policy Office of the Assistant Secretary for Planning and Evaluation	Arlene Joyner Director, Industrial Base Management and Supply Chain Administration for Strategic Preparedness and Response
Jacqueline Corrigan-Curay Principal Deputy Center Director, Center for Drug Evaluation and Research U.S. Food and Drug Administration	Jennifer Maguire Director, Officer of Pharmaceutical Quality/Office of Quality Surveillance U.S. Food and Drug Administration
Brooke Courtney Senior Regulatory Counsel, Office of Counterterrorism and Emerging Threats U.S. Food and Drug Administration	Manuel Osorio Lead, CBER Advanced Technologies Team U.S. Food and Drug Administration
Stuart Evenhaugen Acting Strategy Division Director, Office of Strategy, Policy, Planning, and Requirements Administration for Strategic Preparedness and Response	Carmi Schickler Deputy Chief of Staff and Attorney Advisor U.S. Drug Enforcement Administration
Adam Fisher Director of Science Staff, Office of Pharmaceutical Quality U.S. Food and Drug Administration

Interested in joining the effort? For membership inquiries, please contact Stephen Colvill and Thomas Roades.