WINDSOR, ON – MAY 8: Registered Pharmacy Technician Dawn Deslippe carefully labels Diane’s dose of carboplatin, one of the two chemotherapy drugs she will receive during this visit. Every step of the process involves verification by at least two people. Hospitals now prepare chemotherapy drugs themselves rather than having them premixed. Diane Marley, 48, was a cancer patient at Windsor Regional Hospital. Last December, she was diagnosed with breast cancer. She will complete her chemotherapy regimen in the next few weeks. She is one of hundreds of cancer patients in Ontario who received diluted chemotherapy over the last year and are still receiving treatment to beat the disease. (Richard Lautens/Toronto Star via Getty Images)
Richard Lautens | Toronto Star | Getty Images
dayFood and Drug Administration Faced with nationwide shortages of more than a dozen cancer drugs, the agency is considering temporarily allowing the import of chemotherapy drugs from overseas manufacturers not currently approved for distribution in the United States, an agency spokesperson told CNBC.
The FDA did not say which manufacturers would be potential candidates for temporary importation of the drugs until approved manufacturers are able to meet the needs of patients.
But, “in these cases, we very carefully evaluate the quality of the overseas product to make sure it is safe for U.S. patients,” the spokesperson said.
The FDA has taken similar action in the past, easing restrictions on imports in the face of drug shortages. In the summer of 2022, the FDA allows imports of infant formula from non-agency-approved manufacturers amid severe shortages in the U.S.
Dr. Julie Gralow, chief medical officer of the American Society of Clinical Oncology, said the shortage is expected to continue through June, but will gradually recede if the FDA lifts import restrictions.
“We hope and estimate that once we get through the next month, we’ll have a more consistent supply,” Gralow said.
U.S. currently in shortage of at least 14 cancer drugs
But doctors in hospitals across the country say the situation is particularly acute for two drugs, cisplatin and carboplatin, because of their importance and widespread use in cancer treatment.
Cisplatin and carboplatin are essential for primary healthcare, according to the World Health Organization.
Intas Pharmaceuticals, one of the largest manufacturers of the drugs, temporarily halted production and it is unclear when the company will resume production.
Up to 20% of cancer patients rely on platinum-based chemotherapy drugs such as cisplatin and carboplatin for treatment. National Cancer Institute.
The American Society of Clinical Oncology says that by 2022, more than 100,000 Americans will be diagnosed with cancer that could be treated with carboplatin or cisplatin, generic drugs that have been on the market for decades.
These drugs are used to treat a variety of diseases, including testicular, ovarian, breast, lung, bladder, and head and neck cancers.
Drug shortages are forcing some hospitals to limit drug supplies by reducing doses and prioritizing patients who would benefit most from treatment.
Some cancer patients could die if the shortage is not addressed quickly, doctors say.
“Legislators in this country need to understand that this is a huge problem right now, and unless something changes in the next few weeks, it could lead to a major national emergency from a patient and healthcare standpoint,” Dr. Abdul said Rafeh Naqash, a physician at the University of Oklahoma Stephenson Cancer Center.
Naqash said his plant is running out of carboplatin. The shortage is a national security issue that needs to be addressed quickly, he said.
“It’s actually getting worse. Something has to happen immediately and change,” said Nakash, who specializes in lung cancer.
He said he recently had to inform a patient that they would not receive carboplatin due to a shortage.
Naqash said, if not eased, such conversations could become more commonplace in the coming weeks.
Naqash said he doesn’t understand why the U.S. doesn’t have a national stockpile of these drugs to fill the gap in emergencies.
“If I go to the grocery store and want kiwis, they usually have kiwis,” said Philip Schwieterman, director of oncology and infusion services at the University of Kentucky Health System.
“It’s unbelievable to me that if I want some cisplatin, even though it’s life-saving, I can’t get cisplatin,” Schwieterman said.
‘Cascading drug shortages’
The shortage of cisplatin and carboplatin stemmed from the temporary shutdown of production for the US market at a plant operated by Intas Pharmaceuticals in India.
Found in FDA inspection “A string of failures” in the facility’s quality control department late last year.
Headquartered in Ahmedabad, India, Intas distributes cisplatin and carboplatin in the United States through its subsidiary Accord Healthcare.
When shortages of cisplatin began in February, many patients switched to carboplatin, which is considered a sister drug, said Marc Phillips, who manages the supply chain for inpatient pharmacies at WVU Medicine, West Virginia’s largest health care system. .
That shift “has led to what we think of as chain drug shortages,” Phillips said.
“One shortage is now causing another,” he said.
Fresenius Kabi, Hikma Pharmaceuticals, Teva and Pfizer make the drugs but have been unable to meet demand since the Intas plant was shut down.
Intas is working with the FDA on a plan to restart production.
But a company spokeswoman, Emily King, said no date had been set.
When factories do restart, production will prioritize drugs based on medical need, King said.
She noted that the FDA’s Office of Drug Shortages and Compliance has identified carboplatin and cisplatin as medically necessary in the U.S. market.
An FDA spokesperson said Intas has begun delivering doses of cisplatin and carboplatin to the U.S. that were previously on hold due to the testing and validation process.
Ensuring Cancer Therapy Continues to Produce
Dr. Karen Knudsen, chief executive of the American Cancer Society, said the drug shortages underscore long-standing economic problems in the generic drug market.
Manufacturers are reluctant to invest more in producing low-cost drugs such as cisplatin and carboplatin, making them vulnerable to shortages when factories shut down, Knudsen said.
Knudsen worries that if the federal government and industry don’t act together to address the problem, the U.S. will enter a cycle of cancer drug shortages.
“We need it to be economically viable so that manufacturing can produce effective, affordable cancer therapies,” she said.
Demand for these drugs will increase in the coming years as the population ages, because older adults are at higher risk of developing cancer, Knudsen said.
Drugs such as carboplatin and cisplatin use large quantities of the precious metal platinum, which comes from South Africa and Russia.
World Platinum Investment Council Forecast major deficit Prices for the precious metal have fallen this year in part due to outages in South Africa due to power shortages and operational problems in Russia over sanctions over the Kremlin’s invasion of Ukraine.
Drugmakers must notify FDA of production disruptions six months in advance, or as soon as possible. Knudsen said the early warning system did not appear to be working effectively.
“The fact that we’re sitting here right now talking about this cancer shortage tells us that either the early warning system wasn’t activated early enough, or that not enough manufacturers were able to overcome the supply chain problem,” she said.
An agency spokesman said the FDA is working with the company to increase supplies to meet patient demand.
A trio of Michigan Democratic lawmakers, Senators Debbie Stabenow and Gary Peters, and Rep. Elissa Slotkin, urged FDA Commissioner Dr. Robert Califf in a letter last month to “use all the powers at his disposal to alleviate this serious disease. shortage.”
The letter said Congress was working on long-term solutions to the drug shortage, which has persisted for years.
