From Scarcity to Sufficiency: Understanding and Resolving the Cancer Drug Shortage in the United States

The US has been struggling with a severe cancer drug shortage for several years. This shortage mainly impacts the chemotherapy drugs, a critical component of cancer treatment, resulting in alterations in the timing and regimen of doses and even missed doses, leaving aside the emotional trauma the patient and caregivers go through. A full dose on the correct schedule is a critical predictor for gauging a patient’s treatment response.

The issue has been deteriorating, with shortages of critical drugs surging by nearly 30% in 2022, reaching their highest point in almost half a decade. While old drug storages remain unresolved, new shortages come up.

This article discusses the underlying reasons behind these shortages, the decisions taken to address the problem in the short term, and provides recommendations for long-term solutions.

Shortages of 14 cancer drugs are posing a threat to the treatment of US cancer patients.

As many as 14 cancer drugs have faced shortages in recent times, affecting the care and well-being of hundreds of US patients with cancer. Some oncology drugs in short supply include Pluvicto, which is a radioligand therapeutic agent that treats prostate cancer; cisplatin, for ovarian, testicular, cervical, bladder, head and neck, and lung cancers; Bacillus Calmette-Guerin (BCG— intravesical immunotherapy), which treats early-stage bladder cancer; methotrexate for breast and soft tissue cancers; fluorouracil, which treats skin cancer, etc.

Top reasons behind the US cancer drug shortage

In this section, aiming to provide a comprehensive understanding of the issue, we will talk about: 1. the drug supply chain vulnerability, as happened with the Intas case — an Indian pharma manufacturer producing cisplatin and carboplatin that suspended production after FDA revealed serious violations of manufacturing protocols with the most striking one being intentional destruction and disposal of documents, as a means to conceal the truth — and 2. the low profit of generic drugs, both contributing to recurring drug shortages.

Vulnerable Supply Chain due to over-reliance on few manufacturers

The US has been dependent on a handful of foreign drug manufacturers to produce certain cancer medications. As a result, the supply of these drugs has been susceptible to interruptions caused by issues such as manufacturing problems, regulatory hurdles, limited production capacity, low-quality drugs, and insufficient supply to meet the rising demands.

The Intas case: At the end of 2022, Intas, an India-based pharma company that supplied 50% of the key cancer drugs (generic cisplatin and carboplatin included) in the US, failed to pass the FDA inspection that took place in November and December 2022 at its facility in Sanand (India), and suspended its production. Then, Intas failed to address the FDA 483 observation regarding its severe control crisis, putting itself on an Import Alert (1st June 2023) that escalated to a warning letter (28th July 2023). Other manufacturers could not compensate for the abovementioned shortages because increasing their cisplatin and carboplatin production capacity requires FDA approval to ensure that the expansion of production lines would maintain stringent sterile conditions.

Generic drug manufacturers experience declines in their profits.

Generic drug manufacturers see their profits sink due to low generic drug prices as a result of intense competition and ever-increasing measures intermediaries take to keep bringing down wholesale prices.

The Teva case: Teva, one of the world’s largest generic producers, plans to reduce low-margin molecules from its portfolio and reallocate its R&D resources, shifting to brand-name drugs and high-value generics.

Short-term solutions to address cancer drug shortages.

While oncologists raise concerns about liability and suboptimal patient care, with the latter worsening due to the lack of guidelines for alternatives, all involved stakeholders are working towards employing tactics and taking initiatives to fix drug shortages, at least in the short term.

Oncologists deliver medicines at low or less frequent doses to cope with the shortage.
Some medical institutes are compelled to take on rationing in care, where patients are prioritized, something that raises ethical concerns.
ASCO has formed an advisory group to release clinical guidance for diseases treated with cisplatin and carboplatin.
The FDA allowed imports of unapproved cisplatin (with non-U.S. Labeling) from China to address the shortage temporarily.

The Cancer Drug Shortage Crisis in the US calls for a holistic approach to address the issue.

The dire need to fix and streamline supply chain issues for cancer drugs calls for a holistic approach that translates into public-private partnerships ensuring patient access to medicines. More specifically, well-orchestrated initiatives and interventions from all stakeholders (government, industry bodies, healthcare providers, and not-for-profit organizations) must come together.

Though there is no single prescription for tackling the cancer drug shortages, incentives for domestic production, buffer stockpiles, innovative business models, and better hospital purchasing decision-making are tactics and solutions that can alleviate the problem.

Incentives for domestic manufacturing

As the challenges of regulating the quality and safety of generic drugs from non-US drugmakers remain, incentives for domestic manufacturing are an answer to drug shortages. To maintain quality, especially in older generic drugs, expensive updates to equipment and facilities are required. Without reward and incentivization for sustained quality, it is unlikely that generic manufacturers will continue to produce crucial generic drugs, posing a threat to supply chain resilience.

Maintaining a “buffer stockpile”

However, the FDA cannot force companies to manufacture above capacity. This means that in cases of high demand, even if the FDA incentivizes production, there is likely to be a gap in the supply.

One of the viable solutions can be to maintain a “buffer stockpile”. The government would need to sign contracts with manufacturers to keep this buffer stockpile handy for contingency situations, as over-reliance on manufacturers can lead to a pricing war.

In its 2020 report, the FDA already highlighted that it would emphasize promoting private-sector contracts to ensure continuity in the supply of essential cancer drugs.

Innovative Business Models

There is a need for innovative business models that address drug shortages. That is the case of Civica Rx, a non-profit organization founded in 2018 to address the drug shortage challenge.

Civica conducts quality control, buys straight from the manufacturers, and builds a six-month inventory that supplies over 55 health systems representing 1,550 hospitals across the US. It ensures manufacturers can continue their operations by employing transparent pricing without rebates. In January 2021, it announced the construction of a sterile injectable manufacturing facility in Virginia to ensure uninterrupted consumables production for injectable drugs.

Better hospital purchasing decision-making

Hospitals should be encouraged and rewarded for making more informed purchasing decisions by choosing reliable vendors or participating in programs like Civica to prevent drug shortages. The FDA could support such a scheme by working on its Quality Management Maturity (QMM).

Key takeaway: Only a preventative mindset can mitigate the risk of cancer drug shortages in the US.

According to the findings of a survey (September 2023) conducted by the American Cancer Society Cancer Action Network (ACS CAN), 1 in 10 cancer patients reports that they have been affected by drug shortages either by having met difficulty in getting alternative medication or having experienced a significant delay in their treatment protocol.

In today’s world, the incidence of cancer in people under 50 years old has increased by 80% globally over the past 30 years, and cancer diagnosis rates are increasing among younger adults in the US. The collective responsibility of all stakeholders is to ensure that cancer treatment advancements are accessible and offer hope for cancer patients.

A preventative mindset and decisive action, in terms of a multi-faceted approach, including proactive measures such as strengthening supply chain resilience, increasing domestic production, and fostering communication and collaboration among all stakeholders, can reduce the risk of cancer drug shortages in the US, ultimately safeguarding the well-being and futures of those in need.

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Sources:

Cancer drug shortages have plagued the U.S. for years. Can they be fixed?

Drugmakers are abandoning cheap generics, and US cancer patients can’t get meds | Health News Florida

Some cancer drugs are in short supply, putting patients’ care at risk. Here’s why

Generics 2030: Three strategies to curb the downward spiral

Teva (TEVA) to Cut Back Generic Drug Production Amid Shortages – Bloomberg

Cancer experts demand action to end ongoing drug shortage: ‘People’s lives are really at stake’ | CNN

Cancer drugs among top 5 most affected by shortages in the US | CNN

The Cancer-Drug Shortage Is Different

Cancer Drug Shortages: Liability Concerns and Fears for Patient Care

https://www.fda.gov/media/169001/download

Clinics ration supplies as cancer drug shortages proliferate –