Today, the U.S. Department of Health and Human Services (HHS) released a white paper highlighting the steps HHS has taken to prevent and alleviate drug shortages and recommending additional solutions for policymakers to consider. The country’s health care system has experienced drug shortages for decades, largely due to market failures and misaligned incentives. With today’s white paper, HHS stands ready to propose solutions and work with Congress to ensure that no patient faces the devastating consequences of drug shortages or is unable to take the medications they need.
“Across the Department, we are working to ensure that millions of Americans have access to the medicines, treatments, and services that save lives and improve health outcomes. It is critical that we take forward and implement the policy, and we urge MPs and all supply chain stakeholders to consider and act on the policy options set out in today’s white paper. ” said HHS Secretary Xavier Becerra.
HHS, through the Assistant Secretary for Planning and Evaluation (ASPE), the Office of Strategic Preparedness and Response (ASPR), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and others, is responsible for the department’s oversight of the pharmaceutical supply chain and its efforts to address disruptions. Improve how you respond. HHS has established a new Supply Chain Resilience and Shortage Coordinator role to enhance implementation of strategies to strengthen supply chain resiliency for pharmaceuticals and other medical products. Guidance issued To increase transparency in our supply chain while continuing to explore additional long-term and short-term solutions. FDA discloses certain testing information to help the public understand the actions FDA is taking to protect the public health. We are also developing a quality management maturity framework that may support the adoption of more resilient manufacturing practices. HHS has also worked with other government agencies on this important 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 to generic drug shortages.
HHS is also taking steps to increase resiliency and redundancy within the market. This effort includes supporting domestic manufacturing of key ingredients and medicines to address a range of vulnerabilities. ASPR has invested $500 million to date to support active pharmaceutical ingredient (API) manufacturing and is exploring ways to leverage it. new authority It was authorized by the President last year to facilitate the introduction of essential medicines, medical countermeasures, and their critical components into the country. Additionally, HHS is developing policies that promote resiliency by considering Medicare payments and additional requirements to support a more diverse supply chain.
While the progress described above is important, HHS believes that effective long-term solutions require additional authorities and resources to align market incentives to reward investments in supply chain resilience. We conclude that this may be necessary. By developing and implementing manufacturer resiliency assessment programs and hospital resilient supply programs, we move toward these goals.
Today’s white paper outlines how these programs operate and help address broader market issues that lead to drug shortages. This white paper focuses on generic sterile injectables (GSIs), which form the foundational layer of hospital care and account for the majority of shortages occurring across therapeutic areas. However, HHS recognizes that these challenges impact other medical products and anticipates that the concepts and solutions described in this white paper may apply to other markets as well. I am.
Key highlights of the white paper include:
- Drug shortages impact patients, families, caregivers, pharmacists, hospitals, nursing homes, hospices, and other individuals and organizations throughout the health care system.
- Drug shortages have been a problem for decades, driven in part by market forces that affect stakeholders across the drug supply chain: suppliers, pharmacies, manufacturers, and intermediaries in the system. I am. Key issues include a widespread lack of transparency, concentration among intermediaries, and generic drug prices that have been pushed to very low levels, making manufacturing, distribution, and purchasing more focused on redundancy and resiliency. This is due to insufficient incentives. These market failures leave pharmaceutical supply chains vulnerable, prone to disruption, and slow to recover from shortages.
- Supply chain resilience involves facilitating processes that are less likely to face disruptions and establishing the ability to withstand and mitigate disruptions to limit the impact if they occur . This resiliency comes from supply diversification through manufacturing capacity redundancy and a balance of domestic and diversified foreign sourcing, and the presence of reliable, efficient, sustainable and robust manufacturing practices.
- HHS has made significant progress in strengthening the system’s ability to respond to shortages. Nevertheless, more effective and durable solutions require additional legal powers and funding to address the root causes of shortages. All supply chain participants participate in these solutions.
- This paper discusses policy concepts to consider, including collaboration with the private sector to develop and implement Manufacturer Resilience Assessment Programs (MRAPs) and Hospital Resilient Supply Programs (HRSPs). As previously mentioned, these programs combined will bring transparency to the market, link purchasing and payment decisions to supply chain resilience practices, and improve supply chain resilience and supply chain resilience, including domestic manufacturing. Investment in chain diversification will be encouraged at scale. Changes that have a major impact on the market. This document focuses on generic sterile injectable drugs used in the inpatient setting, given their importance in acute inpatient care and the relative risk of supply disruption. However, HHS recognizes that these challenges impact other products, so the solutions described here may be applicable to other healthcare organizations. other markets.
The white paper, “Policy Considerations to Prevent Drug Shortages and Reduce Supply Chain Vulnerabilities in the United States,” is available at: https://aspe.hhs.gov/reports/preventing-shortages-supply-chain-vulnerabilities.
