For far too long shortages have occurred with many classes of drugs and the impact on patients has been significant: treatment delays, the use of less effective treatments, or missed doses of therapies, often with life-threatening results. Patient access to needed drugs can mean the difference between life and death.
Shortages are systemic and have long-lasting impacts on patients, health systems, and future innovation.
Economic factors underpin 2023 shortages
Low prices: Drugs with low prices paid to manufacturers face a higher risk of shortage. In 2023, product discontinuation rose by 40%, from 100 in 2022 to 140 in 2023, as tight margins drove manufacturers out of the market.
Manufacturing complexity: Drugs with higher manufacturing complexity are more vulnerable to shortage. Complexity can include therapeutic classes that need dedicated facilities, or active ingredients that require complex chemical synthesis.
Geographic concentration: Drugs in which the active pharmaceutical ingredient (API) and/or finished dose are made in a single or few locations are more at risk of shortage. Among drugs newly in shortage, the U.S. produces nearly half of total volume for solid orals (43%) and sterile injectables (49%).
Quality concerns: Facilities where drugs in shortage are made are more likely to have had inspection issues. Poor inspection results can provide a warning signal about the potential location of future problems.
Get the facts about the factors most correlated with drug shortages:
Policymakers, regulators, industry, payors, health systems and other stakeholders must act to identify and respond to the risks and vulnerabilities in the medicines supply chain – with a goal to ensure patients have access to the therapies they need. The undersigned organizations issued a Call to Action to mitigate and prevent drug shortages in the United States.
Actions should address both short-term and long-term needs and include risk mitigation strategies, public and private investment and partnerships, payment reform to reward reliability and manufacturing quality, coordination and accountability, and policy reforms. Major areas include:
Medicines supply chain resilience and reliability activities should be coordinated among federal agencies and non-governmental stakeholders. Coordination efforts should include the organization of multi-disciplinary efforts, defining measurable outcome metrics for implementation efforts, and strategic planning activities to maximize the utility of new programs and increase the impact of existing initiatives. Additionally, necessary authorities and sufficient funding should be allocated to lead these cross-cutting efforts to improve drug supply chain resilience and reliability.
A critical need exists to invest in early warning capabilities that signal threats to and vulnerabilities within the pharmaceutical supply chain. Recent and ongoing shortages in oncology drugs have made clear that while data signals exist that can help predict upstream pharmaceutical supply chain risk, the data are not integrated in a way that can generate actionable insights to prevent or mitigate drug shortages.
A need exists to establish a vulnerable medicines list in the United States, as a complement to or a component of already established essential medicines lists, which factors in supply chain vulnerabilities. A vulnerable drugs list would be continually updated to reflect conditions that may increase the likelihood that a particular medicine could go into shortage.
Policymakers and public and private drug purchasers should establish and utilize payment and purchasing models that value and incentivize supply chain quality, resilience, and reserves for drugs vulnerable to shortages. This will require developing or adopting objective metrics of quality, resilience, and reserves to drive these incentives.
Policymakers should consider a range of reforms to foster more security in the manufacturing base for U.S. drug products to reduce the risk of disruptions and shortages. Some possible reforms include economic or other incentive measures that will encourage multiple suppliers for key drugs, geographic diversification of manufacturing facilities, and manufacturing location and component supply redundancies. Additionally, the development of tools and standards can help reduce technical barriers and facilitate wider adoption of advanced manufacturing technologies (AMTs) that have the potential to improve manufacturing efficiency, reduce production costs, reduce environmental footprints, and support supply chain resilience.
To better understand the root causes of persistent drug shortages, non-biased and nonpartisan research into the complex market dynamics associated with generic medicines is necessary. Targeted pilots or demonstration projects can test interventions on a limited scope before scaling more broadly.
A fundamental shift in the market for lower-priced drugs is needed to align supply and demand forces to create a predictable, sustainable, and high-quality supply chain that can reliably provide critical drugs to patients. Policymakers and public and private drug purchasers must value quality and resilience through sustainable prices of drugs that demonstrate these characteristics. While the programs and policies to achieve this are being developed and implemented, there will continue to be a need in the near term for better tools to understand supply chain vulnerabilities and shortage risks, and ways to proactively intervene in a coordinated manner.
Only by addressing both the short-term and long-term aspects of this issue will we be able to minimize impacts of the ongoing drug shortage crisis.
Survivor Views: One in ten impacted by recent drug shortages.
National Comprehensive Cancer Network (NCCN) Best Practices Committee: Drug shortage follow-up survey results.
Why cancer medicines are and continue to be vulnerable to drug shortages.
Identifying and addressing vulnerabilities in the upstream medicines supply chain to build resilience and reduce drug shortages.
Drug shortages: Landscape assessment of policy proposals to prevent and mitigate drug shortages.
Drug shortages in the U.S. 2023: A closer look at volume and price dynamics.
Duke Margolis Center for Health Policy: Advancing federal coordination to address drug shortages.
Drug shortages: Causes and solutions.
Drug Shortage Task Force Letter to Congression Leadership on July 26, 2024 and Drug Shortage Task Force
