Oncology Drug Shortages: Impacts, Policy Reforms, and Advocacy Imperatives

Abstract

Oncology drug shortages have reached unprecedented levels and have had a substantial impact on the treatment of cancer patients, which can include medication rationing, delayed treatments, and inferior therapeutic substitutions. This manuscript outlines systemic drivers of supply chain vulnerabilities that lead to drug shortages, presents medicines supply chain data analyses of ongoing shortages, and proposes actionable policy reforms for advocacy to address patient needs and build resilience and sustainable change in the pharmaceutical supply chain.

DRUG SHORTAGES LANDSCAPE

Introduction

Drug shortages have become increasingly common for many classes of drugs, causing significant impact on patients by challenging the ability of providers to prescribe and treat patients for a variety of diseases, including cancer.¹ At the end of 2024, the US Food and Drug Administration (FDA) reported 98 active and ongoing drug shortages in the United States.^2,3 Policymakers, regulators, industry, payors, health systems and other stakeholders are working 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 US Pharmacopeia (USP) Medicine Supply Map is a tool that uses predictive analytics to provide insights into the global medicines supply chain, aiming to identify and mitigate potential risks and disruptions.^4,5 The Medicine Supply Map leverages multiple sources of information to identify worldwide sites of pharmaceutical ingredients and finished dose medicine manufacturing. Data sets from USP, FDA, the Centers for Medicare & Medicaid Services (CMS), European Medicines Agency (EMA), World Health Organization (WHO), and private sector sources are utilized by the Medicine Supply Map platform. The Medicine Supply Map insights are also informed by information about the use of USP quality standards in most FDA-registered finished dose and active pharmaceutical ingredient (API) manufacturing facilities. These data are enriched with information about risk drivers such as price and ingredients and cover 92% of FDA-approved generic prescription drugs.

Using the tool, USP identified 4 factors that can significantly increase risk for a drug shortage:

• Low prices: Drug products, commonly older generics, with low prices, have a higher risk of drug shortage. The procurement of medicines is typically based on the lowest price, not quality or resilience.

• Manufacturing complexity: Drugs with higher manufacturing complexity, such as sterile injectable medicines, are more vulnerable to shortage. Certain therapeutic classes are also more complex to manufacture. For example, certain antibiotics require dedicated facilities, and certain active medicine ingredients 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 at a higher risk of shortages for several reasons including trade disputes.

• Quality concerns: Quality-related issues that surface after regulatory agency inspections and manufacturer recalls can also inform drug shortage risk and serve as indicators of potential drug shortages.

The Medicine Supply Map calculates a Vulnerability Score based on the 4 factors noted and over 100 additional risk factors including additional measures of market and supply economics (e.g., market concentration), manufacturing complexity [e.g., active pharmaceutical ingredient (API) synthesis complexity], and more, to predict the likelihood of a shortage for a given drug. Higher scores indicate greater risk for a drug to be in shortage in the next 12 months. The score can help stakeholders, including hospitals, distributors, manufacturers, and the US government to prioritize mitigation efforts for the medicines most at risk of drug shortage. The average prescription drug product in the United States has a Vulnerability Score of ∼20%.

ONCOLOGY DRUG SHORTAGES

Oncology medicines have recently been in the media spotlight with reports of hospitals rationing doses.^6–9 To better understand the oncology medicines at risk of shortage, in late October 2023, USP shared data on vulnerabilities in the supply chains of 20 cancer medications, many of which are included on the WHO Essential Medicines List.¹⁰ The analysis found that many of the medicines had inherently vulnerable supply chains and were at greater risk for shortage compared with other generic medicines; 7 of the 20 essential cancer medicines analyzed are 3 to 5 times more likely to be in shortage than the average medicine.¹⁰

Two examples of oncology drug shortages are cisplatin and carboplatin—platinum-based chemotherapy drugs used to treat multiple types of cancer and often used in combination with other chemotherapy drugs to improve treatment outcomes. Figure 1 shows that both drugs have had significantly elevated scores since 2023. Carboplatin has been in shortage since April 2023, according to the FDA.³ Cisplatin experienced a prolonged shortage that lasted from February 2023 until June 2024. The USP Supply Chain Vulnerability Score for cisplatin has remained elevated, indicating a consitently increased risk of shortage. In May 2025, cisplatin reappeared on the American Society of Health-System Pharmacists (ASHP) shortage list,¹¹ as predicted by the USP Medicine Supply Map.

FIGURE 1.

Medicine supply map vulnerability scores of cisplatin and carboplatin.

ROOT CAUSES OF ONCOLOGY DRUG SHORTAGES

The 4 main factors that increase the risk of drug shortage noted previously—low prices, geographic production concentration, manufacturing complexity, and quality concerns—are interrelated and, in combination, can impact the supply chain of medicines and drug products. For example, manufacturing complexity increases the cost of making a medicine, which can yield an unsustainable margin when combined with low prices of certain drug products. To improve margins, the manufacturers may try to reduce costs by geographically concentrating production in large facilities that become single points of failure. The low price and low margin dynamic impedes the ability of industry to create manufacturing redundancies and may lead to underinvestment in quality management systems. Sudden surges in demand or supply disruption can also impact medicine availability by triggering new or worsening existing drug shortages as manufacturers and the market struggle to respond effectively.

For cancer therapies, a combination of these factors is common. Cancer medicines are complex to manufacture due to their inherent properties and mechanism of action; antineoplastics are harmful to human cells by design and the protocols to ensure worker safety in their production facilities are stringent. This complexity can influence the supply of these medicines, with manufacturers reluctant to begin or forgoing production. The low price of older, generic oncology medicines is also a shortage risk factor. Essential injectable cancer drugs in shortage have an average price of $2 per vial, while essential injectable cancer drugs not on the FDA shortage list have an average price of $1423 per vial. The price disparity is less dramatic for solid oral cancer medicines but still noteworthy—the average cost of an oral solid drug in shortage was $1 per pill, while those not in shortage have an average price of $7.50 per pill.¹⁰

Geographic concentration of production location also impacts cancer therapy availability and supply chain vulnerability. Table 1 compares the location of generic cancer therapy production in 2022 and 2025 and provides available Vulnerability Scores. During both time periods, the production of several cancer medicines was concentrated in a single facility. In both years, 100% of the US supply of nivolumab is made in one facility. For tamoxifen, 50% of the US supply was made at a single facility in the United Kingdom in 2022; in 2025, 69% of that cancer drug is made at one facility in India. These data highlight the high vulnerability to disruption of supply posed by concentration of production.

TABLE 1.

Production Locations in 2022 and 2025, Vulnerability Scores as of January 2025, and FDA Shortage Status as of May 2025 for Select Generic Cancer Therapies

Drug (Form)	Production of the US Volume Shares, by Location, for Select Essential Oncology Medicines (%, October 2022)	Production of the US Volume Shares, by Location, for Select Essential Oncology Medicines (%, January 2025)	Vulnerability Score (%, January 2025)	FDA Shortage Status (May 2025)
Etoposide (injectable)	69 India	39, India	56.1	No
Nivolumab (injectable)	100, United States	100, United States	NA	No
Tamoxifen (solid oral)	50, United Kingdom	69, India	5.1	No
Cisplatin (injectable)	69, India	42, India	79.1	Discontinued
Dexamethasone (solid oral)	98, United States	75, United States	5.1	No
Rituximab (injection)	40, Belgium	37, Belgium	NA	No
Docetaxel (injection)	44, India	58, India	63.7	Discontinued
Letrozole (solid oral)	51, India	86, India	4.0	No

In addition, some of the facilities analyzed are responsible for the production of multiple cancer medicines and represent nodes of high vulnerability for the cancer medication supply chain. For example, as of January 2025, one facility in India produces a large amount of the US supply of several oncology therapies, including 24% of cisplatin, 84% of temsirolimus injection, 43% of carmustine, and 8% of carboplatin.⁴

PATIENT IMPACT, CLINICAL CHALLENGES, AND ETHICAL IMPLICATIONS

The impact of a drug shortage on individuals with cancer and their families has been significant and includes delays in treatments, the use of less effective treatments, and missed doses of therapies, often with life-threatening results.^8,12

Clinicians are experts in caring for patients, and until recently, have not been expected to be experts in managing drug shortages and vulnerabilities in medical supply chains. However, because they—and their patients—have increasingly encountered the effects of drug shortages, many are expected to understand how supply chains operate and how a shortage may affect a patient’s treatment plan and care.¹³ During times of drug shortage, clinicians face significant challenges to meet care standards when managing patients and often encounter difficult ethical decisions. Three quarters of oncology pharmacists report delays, dose reductions, or regimen changes due to shortages, often leading to inferior outcomes.¹ Additional challenges faced include managing drug shortages and limited inventory in hospitals,¹⁴ rationing limited supplies of key medicines and equipment,¹⁵ managing consequences of quality control failures or compromised stockpile access,¹⁶ and balancing clinical trial integrity, necessary protocol revisions, and enrollment.^1,12

With the increase of drug shortages, clinician organizations, including the American Society of Clinical Oncology (ASCO), have developed both clinical and ethical guidance for the prioritization of antineoplastic agents in limited supply for first intervention.^17–19 In addition, hospitals and professional societies have developed evidence-based prioritization protocols during shortages, including therapeutic substitutions and clinical trial drug reallocation^12,20 and cancer-drug repositories that repurpose unused medicines have emerged.²¹

ADVOCACY FOCUSED INTERVENTIONS

Coalition Building

In response to the continued unmet need of persistent drug shortages that threaten the health of patients by disrupting access to needed medicines, many—including patients,²² public health advocates,^23,24 and clinicians,^{12,21,25–27} recognize the need for a comprehensive approach and have called on policymakers to take action to mitigate and prevent drug shortages. In 2024, ASCO mobilized 500 oncologists to demand congressional action on drug shortage issues.²⁶

To create a more powerful and focused advocacy message on drug shortages, USP partnered with the American Cancer Society Cancer Action Network (ACS CAN) to establish the Drug Shortage Task Force. The Task Force, made up of nearly 30 stakeholders, includes oncology and other advocacy organizations representing patients, providers and health systems, and public health groups, who face the harms of this systemic issue and who are committed to addressing the root causes of drug shortages.²⁸ Coalescing around its collective Call to Action,²⁸ the Task Force has helped raise awareness of the severe harms of shortages and the root causes behind them. Together, through consistent convening and targeted outreach, the group has worked to educate policymakers on the issue of drug shortages while providing valuable insights and practical, data-informed solutions. The Task Force has helped to raise the awareness about this key issue and bring stakeholders across the supply chain together to drive meaningful change.²⁹

While the Task Force has its own strategy to effectively advocate for these solutions, it is just as important that this strategy and coalition work alongside other groups, consortia, and alliances, representing stakeholders across the supply chain, to help reduce drug shortages.^22,30,31 The need continues to amplify advocacy messages, promote evidence-based solutions to address oncology and all drug shortages, and urge legislation to bolster supply chain resilience.

EVIDENCE-BASED AND DATA-DRIVEN POLICY SOLUTIONS

Shortages are systemic and have long-lasting impacts on patients, health systems, and future innovation and solutions must also be systemic. While drug-specific prevention and mitigation activities are critical, changes are also needed to ensure patient access to necessary medical treatments. Actions should address both short-term and long-term needs and include risk mitigation strategies, public and private investments and partnerships, payment reform to reward reliability and manufacturing quality, coordination and accountability, and actionable policy considerations. Some of the major policy areas that coalitions such as the Drug Shortage Task Force focus on include:

• Coordinating pharmaceutical supply chain resilience and reliability efforts: Disparate medicines supply chain resilience and reliability activities should be coordinated among federal agencies and non-governmental stakeholders—with necessary authorities and sufficient funding—and include the organization of multidisciplinary 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.

• Supply chain visibility: 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.⁵

• Establish and leverage a vulnerable medicines list (VML): A VML is a list of medicines derived from an assessment of their essentiality, demand, and supply chain vulnerabilities and a mitigation strategy that can be used to identify the most critical medicines at risk of shortage, allocate finite resources to improve medicine supply chain resiliency, inform future investments to manufacturers of vulnerable medicines, and preserve patient access to necessary medicines.³² A VML has recently been developed and is intended to complement other resources to identify potential drugs at risk of shortage in the United States and be used as prevention and mitigation tool for policymakers and medicines supply chain stakeholders.³³

• Align the market to incentivize a high-quality and adequate supply chain: 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.

• Bolster manufacturing capacity: Policymakers should consider a range of reforms to foster more security in the manufacturing base for US 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.

CONCLUSIONS

Over the past 2 decades, the drug supply chain has become longer, more complex, and fragmented, which has in turn led to a lack of visibility and vulnerability. The vulnerability has resulted in shortages of critical oncology and other therapies. Successful advocacy to reduce drug shortages must balance short-term drug shortage crisis management with long-term structural reforms to alleviate the root causes of drug shortages. Advocacy coalitions have become an important tool to catalyze action and fight for lasting, evidence-based and data-driven solutions. The collective voices of many stakeholders can transform a fragmented system into one that ensures reliable access to lifesaving therapies.