HHS Publishes White Paper on Supply Chain

April 2, 2024
The paper focuses on preventing and mitigating drug shortages

On April 2, the U.S. Department of Health and Human Services (HHS) announced via a press release that it has released a white paper highlighting steps HHS has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider.

The press release says that “Drug shortages have occurred in the nation’s health care system for several decades, largely due to market failures and misaligned incentives. With today’s white paper, HHS offers solutions and stands ready to work with Congress to ensure no patient faces the devastating consequences of drug shortages or goes without needed medicines.”

Further, “Through the Assistant Secretary for Planning and Evaluation (ASPE), Administration for Strategic Preparedness and Response (ASPR), the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and others, HHS has been working to improve how the department monitors the pharmaceutical supply chain and responds to disruptions. HHS has established a new Supply Chain Resilience and Shortage Coordinator role to strengthen implementation of strategies to enhance supply chain resilience for pharmaceuticals and other medical products, and has issued guidance to increase supply chain transparency, while continuing to consider additional long and short-term solutions. FDA discloses certain inspection information to provide the public with an understanding of actions the Agency takes to protect public health and is also developing a quality management maturity framework that may support adoption of manufacturing practices that are more resilient. HHS has also collaborated with other government agencies on this critical issue. For example, last month HHS and the Federal Trade Commission jointly issued a Request for Information to better understand the causes – and potential solutions – of generic drug shortages.”

HHS has also taken steps to increase resilience and redundancy within the market, according to the press release. Additionally, HHS acknowledges that longer-term solutions may require additional input from authorities and resources.

HHS has the press release.