Duke-Margolis Drug Shortages Request for Information Comment Letter

July 7, 2023

Dear Chair, Ranking Member, and Members:

The Robert J. Margolis, MD, Center for Health Policy at Duke University (“Duke-Margolis” or “the Center”) appreciates this opportunity to provide comments and recommendations to address nationwide drug shortages. While recent drug shortages, particularly of oncology medications, have been particularly severe and require urgent response, chronic shortage issues have plagued the U.S. healthcare system for decades. The Center thanks the Chair and Ranking Member, and their respective committees, for their focus on the underlying root causes that contribute to repeated drug shortages, and that must be addressed to prevent future shortages.

The recommendations provided in this response are based on the Center’s years of research and stakeholder engagements aimed at promoting drug supply chain resilience and preventing drug shortages. The Duke-Margolis Center for Health Policy earlier this year launched a new Drug Supply Chain Resilience and Advanced Manufacturing Consortium (“the Consortium”), which consists of a group of experts in supply chain, manufacturing, regulatory science, national security, and drug shortages from academia, private industry, and governmental agencies. The mission of the Consortium is to identify effective policy solutions that promote a resilient drug supply chain with advanced manufacturing capabilities and reduce the frequency and severity of drug shortages.

The recommendations herein do not necessarily represent the views of any Consortium Members or Observers, but are informed by the Center’s work with the Consortium. In the coming weeks and months, Duke-Margolis and the Consortium will publish a series of research and recommendations related to supply chain resilience and drug shortages.

We have provided individual responses to the specific RFI questions below. To summarize these responses, our recommendations include:

1. The federal government should create and fund a cross-cutting and sustained federal coordination initiative to address drug shortages. This initiative should connect the pieces to the puzzle that sit in various federal agencies, and set specific goals with parties identified as accountable for implementation.
2. The federal government should support development and implementation of a robust toolkit of resources, most notably FDA’s Quality Management Maturity (QMM) program, that measure supply chain resilience and quality.
3. The federal government should provide well-targeted financial incentives for supply chain resilience through innovative reimbursement mechanisms and other means.
4. The federal government should pursue a proactive, coordinated focus on preventing supply-driven drug shortages.
   1. Refocus ASPR’s mission and provide funding (especially for the new Industrial Base Management and Supply Chain office) to prioritize ensuring availability of the most essential medicines
      1. Regardless of product type. Current focus is solely on medical countermeasures and pandemic-related medicines.
      2. Regardless of the reason for lack of availability. Current focus is solely on emergency events such as bioterrorism and pandemics.

Our team looks forward to working with you, your committees, and your staff to promote a more resilient U.S. drug supply chain and reduce the frequency and severity of drug shortages.

Sincerely,

Stephen Colvill, MBA
Duke University MBA and Research Associate

Marianne Hamilton Lopez, PhD, MPA
Senior Research Director

Gerrit Hamre, MA
Research Director

Cameron Joyce, MPP
Senior Policy Analyst

Thomas Roades, MPP
Senior Policy Analyst