Cancer drugs have once again become one of the top five drugs in short supply. On February 10, 2023, the FDA reported a shortage of carboplatin and cisplatin: two critical chemotherapy drugs needed to treat ovarian cancer and testicular cancer, respectively. These platinum-based treatments are also used to slow the growth of cancer cells in lung, bladder, breast, cervical, endometrial, head, and neck cancer.
Currently, these drugs are on backorder and expected to be intermittently available by this summer at the earliest. The majority of drug makers (Eugia, Fresenius Kabi, and Pfizer) have reported the shortages are due to increased demand, while one company, Accord, cited manufacturing delays.
These aren’t the only drug shortages impacting patients, either. Other cancer treatments facing shortages include Tice BCG Intravesical Injections, Pluvicto, Methotrexate Injections, and Fluorouracil Injections. Shortages of normal drugs like local anesthetics, IV antibiotics like penicillin, basic hospital drugs, asthma drugs, ADHD treatments, and common oral medications have contributed to growing uncertainty—and national security concerns.
Homeland Security Report on Drug Shortages
In March 2023, Homeland Security & Governmental Affairs released a report on the risks of these drug shortages. The report highlights that drug shortages are not a new problem. At the end of 2022, active drug shortages reached a high of 295 different drugs. While the average shortage lasts 18 months, some drugs have already been in short supply for over a decade. As of May 25, 2023 there are 137 drugs listed as “Currently in Shortage” by the US FDA—and the threat of shortage is increasing.
According to the report, the increase in shortages has been caused by economic factors, lack of supply chain visibility, and over-reliance on overseas sources for medications and raw materials. Sterile injectable products, like the cancer treatments noted above, are at increased risk due to 90 to 95% of these drugs originating in India and China. Additionally, nearly 80% of active pharmaceutical ingredient (API) manufacturers are located overseas.
With so many manufacturers highly concentrated in certain geographical areas, it makes these drugs that much more susceptible to disruptions. For example, in 2021, a major ice storm in Texas resulted in a manufacturing plant closure in Texas. This closure led to a shortage of the material needed to make syringes.
Other Causes of Recent US Drug Shortages
In addition to increased demand, foreign manufacturing, and lack of visibility into the supply chain, other factors have contributed to the recent drug shortages as well. According to Resilinc’s EventWatchAI data, the Life Science industry faced a total of 10,700 disruptions in 2022—marking a 32% YoY increase. The top five types of disruptions in Life Sciences were factory fires, mergers & acquisitions, business sales, leadership transitions, and labor disruptions.
Financial difficulties and quality control issues are also a major factor. According to a recent article in the New York Times, currently, drugmakers are more incentivized to prioritize lower costs as opposed to higher quality. This means companies often cut corners which can lead to halts in production and factory shutdowns when the FDA requests issues to be remedied. For example, in February, when Akorn Pharmaceuticals filed for bankruptcy, its products were recalled because no staff were available to address quality control concerns.
Another company, Intas Pharmaceuticals, produces three chemotherapy drugs that are currently in short supply: methotrexate, carboplatin, and cisplatin. Intas Pharmaceuticals had to temporarily shut down due to serious quality-control violations issued by the FDA.
Many of the cancer drugs in shortage are generic medications, which are often not profitable for drugmakers to produce. This is leading to scarcity and consolidation, with only a few key players remaining. To remedy this issue, officials are debating measures like tax incentives for generic drugmakers and greater transparency around generic drug quality.
Recommendations for Improving Drug Shortages in the US
Many of the recommendations from the report (on pages six and seven) point to increased supply chain visibility and resiliency, such as conducting supply chain risk assessments, monitoring supply chain vulnerabilities, and streamlining efforts to predict and mitigate potential disruptions.
The report notes: “Neither the federal government nor industry has end-to-end visibility of the pharmaceutical supply chain—from the key starting materials, APIs, finished dosage and various other manufacturers that are “upstream”—to the “downstream” suppliers, which include purchasers and providers. This lack of transparency limits the federal government’s ability to proactively identify and address drug shortages.”
Resilinc recommends that drug and medical device manufacturers report increased demand and export restrictions to the FDA. This will help the FDA respond to and prevent potential drug shortages. Next, companies should find alternative sites for those that are facing production cuts, shortages, or recalls—as companies continue to cut production of drugs that do not create revenue due to high production costs.
For a quick fix, Resilinc echoes the recommendations of the report: companies should utilize AI mapping to gain visibility into their most likely sub-tier supply chain network. Resilinc’s Autonomous AI Mapping solution helps companies gain rapid visibility into their “most-likely” supply chain network—leveraging over a decade of supplier intelligence harnessed from public domain sources, and cleansed by Resilinc’s advanced analytic techniques.
Finally, companies should collaborate with their suppliers to create long-term contracts for drugs to ensure they will not be impacted by future shortages. Having a close relationship with your suppliers is a valuable tool. Better relationships often mean getting preference when supplies are low and receiving more timely updates from suppliers.
To learn more about notable recalls and steps to take to prevent impacts to your supply chain, download Resilinc’s Special Report: Rising Drug Shortages – Root Causes and Potential Solutions.