Doctors treating cancer patients nationwide are facing a shortage of essential generic chemotherapy drugs, a situation that many fear could lead to widespread rationing.
The shortages stem from manufacturing problems, shipping delays and decisions by some companies to stop producing the medications, according to the Food and Drug Administration.
The decades-old medicines are challenging to make in sterile plants and command a very low price in the United States. But they are considered among the most effective treatments for some cancers without more targeted options, including some breast, lung, and head and neck cancers.
In the case of an injection called ifosfamide, which is used to treat sarcomas, lymphomas and testicular cancers, doctors are already convening to decide who to treat.
“There are some individuals who won’t be able to receive this drug, even if it is the best option for them, which puts pharmacists, doctors, patients and families in a horrific situation,” said Dr. Andrew Shuman, a head and neck cancer surgeon and professor at the University of Michigan who has testified to Congress about previous drug shortages.
In Michigan, where Dr. Shuman practices, some doctors are prioritizing scarce doses for patients who are most likely to see the greatest benefit, he said. It is a process that tends to favor younger patients with a chance for a full recovery.
Hospitals and cancer clinics working with Premier, a company that negotiates discounts on drugs and supplies for health providers, have seen only 38 percent of their orders for ifosfamide filled and about two-thirds for the drug cisplatin, which is for ovarian, testicular and bladder cancers, according to Amanda Forster, the company’s vice president of integrated communications. The company works with about 4,200 hospitals and health systems nationwide.
While rationing does not appear to be widespread, some medical practices have begun spacing out the time between doses and scheduling patients in consecutive appointments to ensure that not a drop of the medication is wasted.
Securing supply for several older chemotherapy drugs, carboplatin, cisplatin and oxaliplatin, “has been very difficult” for the Florida Cancer Specialists and Research Institute, said Dr. Lucio Gordan, the company president.
“These three drugs remain the backbone of many cancer therapies (lung, ovarian, head and neck, testicular, breast, colon cancers),” Dr. Gordan said in an email.
Emily Hilliard, a spokeswoman for the Department of Health and Human Services, which includes the F.D.A., said the agency was working to alleviate the shortages and considering temporarily allowing imports of medications from companies that do not typically send supplies to the United States.
The shortages have already made waves worldwide, with regulators in India raising price caps to account for the soaring cost of platinum, a key part of making carboplatin and cisplatin. Regulators in Europe warned that ifosfamide supplies may not rebound until next year.
Three years ago, two of the other chemotherapy drugs currently in tight supply went into a monthslong shortage. Rationing of the 40-year-old medications, carboplatin and cisplatin, touched off intense discussions in Washington among lawmakers and experts about finding a durable solution but few measures were put in place.
“From a systemwide policy change, not a single thing has changed,” said Laura Bray, the executive director of Angels for Change, a nonprofit that works to alleviate drug shortages. “It’s time for Washington to get involved and help the citizens of the United States ensure that we have lifesaving medicine.”
Ms. Bray, who began to work on drug supply issues after her daughter faced a chemotherapy shortage in 2019, said her organization provided funding to begin U.S. manufacturing of two shortage-prone chemotherapy medications. The Mark Cuban Cost Plus Drug Company recently began to make carboplatin and another cancer medication, methotrexate, at a Texas facility.
She said she believed the supply from Texas would help in the shortage if oncology providers refrained from panic buying. “There is enough supply for everyone to keep moving forward if everybody works together,” she said.
Baxter, a medical product company based near Chicago, said in a statement that it relied on a contract manufacturing facility in Halle, Germany, to make its supply of the drug ifosfamide. Last year, F.D.A. inspectors discovered sterility problems at the facility, including bacteria in a product-filling area and a “forest cockroach” elsewhere in the plant, according to the agency’s inspection report.
The F.D.A. sent the manufacturer a warning letter in March. An F.D.A. shortage report said Baxter estimates that the medication will be available again in October.
Baxter said that the manufacturer had reduced operations and interrupted manufacturing and product release. The company said it was working to increase supply and had started a process to “help ensure fair and appropriate distribution of available product.”
The situation is well known to policymakers, said Dr. Shuman, the Michigan oncologist, who said there had been a decade of discussion about problems around an aging manufacturing base for many sterile generic drugs. Experts have also examined a complex payment system in which intermediaries draw up contracts that distort the typical forces of supply and demand.
“These are going to keep happening until we address the root cause,” he said.
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