WINDSOR, ON – May 8: Registered pharmacy technician Don Deslip carefully labels Diane’s dose of carboplatin, one of two chemo drugs she will receive during the visit. Each step of the process involves verification from at least two people. Hospitals now prepare chemo drugs themselves instead of pre-mixing them. Diane Marley, 48 is a cancer patient at Windsor Regional Hospital. She was diagnosed with breast cancer in December. He is finishing up his chemo regimen in the next few weeks. He is one of hundreds of Ontario cancer patients who received chemotherapy last year and who are still undergoing treatment to beat the disease. (Richard Lautens/Toronto Star via Getty Images)
Richard Lautens Toronto Star | Getty Images
me Food and Drug Administration – facing a national deficit More than a dozen cancer Medicines – is considering allowing the temporary importation of chemotherapy drugs from foreign manufacturers that are not currently approved for distribution in the United States, an agency spokeswoman told CNBC.
The FDA did not say which manufacturers would be potential candidates to allow them to be temporarily imported of medicine Until authorized manufacturers are able to meet the needs of patients.
But, “in this case, we very carefully evaluate the quality of the foreign product, ensuring that it is safe for US patients,” the spokesperson said.
The FDA has taken similar steps in the past to relax restrictions on imports when faced with drug shortages. In the summer of 2022, the FDA allowed imports of infant formula from non-agency-approved manufacturers when there was a critical shortage of formula in the United States.
The American Society of Clinical Oncology estimates that shortages will continue through June, but especially if the FDA lifts the import ban, according to Dr. Julie Gralow, the group’s chief medical officer.
“We’re hoping and assuming we’ll have a more stable supply once we get through next month,” Gralow said.
At least 14 cancer drugs are currently in short supply in the United States
But doctors at hospitals around the country say the situation is particularly acute for two drugs — cisplatin and carboplatin — because they are so fundamental and widely used in cancer treatment.
The World Health Organization says cisplatin and carboplatin are essential for basic health care.
Intus Pharmaceuticals, one of the largest manufacturers of these drugs, temporarily stopped 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.
And the American Society of Clinical Oncology says more than 100,000 Americans in 2022 will be diagnosed with cancers 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 wide range of diseases, including testicular, ovarian, breast, lung, bladder, and head and neck cancers.
Drug shortages have forced some hospitals to ration drugs by reducing doses to increase their supplies, and to prioritize patients who would benefit most from treatment.
Doctors say some cancer patients may die if the deficiency is not addressed quickly.
“The country’s lawmakers need to understand that this is a big problem right now, where if something doesn’t change in the next few weeks it could lead to a major national emergency from a patient and health care perspective,” said Dr. Abdul Rafeeh Nakash, Stephenson Cancer Center at the University of Oklahoma. A doctor at the center.
Nakash says he is about to run out of carboplatin. He said the deficit is a national security issue that needs to be addressed urgently.
“The situation on the ground is getting worse. Something needs to happen and change immediately,” said Nakash, an expert in lung cancer.
He said he recently had to inform a patient that they would not receive carboplatin because of a shortage.
If relief doesn’t come, such conversations will likely become more common in the coming weeks, Nakash said.
Nakash said he doesn’t understand why the U.S. doesn’t have a national stockpile of the drug to fill the gap in emergencies.
“If I go to the grocery store and I want a kiwi, there’s usually kiwi,” says Philip Schwetterman, MD, director of oncology and infusion services at the University of Kentucky Health System.
“It boggles my mind that if I want some cisplatin, I can’t get cisplatin even though it saves lives,” Schwetterman said.
‘A cascading drug shortage’
The shortage of cisplatin and carboplatin is due to the temporary cessation of production for the US market at a plant in India operated by Intus Pharmaceuticals.
Intus decided to stop production after an FDA inspection found one “Cascade of Failure” At the facility’s quality control unit late last year.
Intus, headquartered in Ahmedabad, India, distributes cisplatin and carboplatin in the US through its subsidiary, Accord Healthcare.
When the cisplatin shortage began in February, many patients switched to carboplatin, which is considered a sister drug, said Mark Phillips, who manages the inpatient pharmacy supply chain for WVU Medicine, West Virginia’s largest health-care system.
Phillips said this change “has led to what we consider a cascading drug shortage.”
“One deficit has now led to another,” he said.
Fresenius Kabi, Hikma Pharmaceuticals, Teva and Pfizer make the drug, but those companies have been unable to meet demand since the Intus plant went offline.
Intas is working on a plan with the FDA to resume production
But no date has been confirmed, company spokeswoman Emily King said.
When the plant reopens, manufacturing will prioritize drugs based on medical need, King said.
He noted that the FDA’s drug shortage staff and the Office of Compliance have identified carboplatin and cisplatin as medically necessary for the US market.
An FDA spokesperson said Intus has begun releasing doses of cisplatin and carboplatin in the US that were previously held up due to a testing and validation process.
Ensuring cancer treatment continues production
Dr. Karen Knudsen, CEO of the American Cancer Society, said the shortage highlights chronic economic problems in the generic drug market.
Knudsen said manufacturers are reluctant to invest more money in producing low-cost drugs like cisplatin and carboplatin, which leaves them vulnerable to shortages when a plant goes down.
Knudsen fears the U.S. is entering a cycle of cancer drug shortages if the federal government and industry don’t work together to solve the problem.
“We need to be financially viable for manufacturing to be able to develop effective, affordable cancer therapies,” he said.
Knudsen said demand for these drugs will increase as the population ages because older people are at higher risk of cancer.
And drugs like carboplatin and cisplatin use the precious metal – platinum – which is found in large quantities from South Africa and Russia.
The World Platinum Investment Council has made a forecast Major deficiency The precious metal is in part this year due to disruptions in South Africa due to power shortages in Russia and operational problems due to sanctions over the Kremlin’s aggression in Ukraine.
Drug manufacturers are required to notify the FDA of production disruptions six months in advance or as soon as possible. Knudsen said the early warning system did not seem to be working effectively.
“The fact that we’re sitting here right now talking about this cancer shortage tells us that early warning systems either weren’t activated early enough, or there aren’t enough manufacturers to be able to overcome the supply chain problem,” he said. .
The FDA is working with the company to increase supply to meet patient demand, an agency spokeswoman said.
A trio of Michigan Democratic lawmakers, Sens. Debbie Stabenow and Gary Peters, Rep. Elisa Slotkin, FDA Commissioner in a letter last month. Robert urged Calif to “use all its existing authorities to alleviate this dire deficiency.”
The letter says Congress is working on long-term solutions to drug shortages, which have been a problem for years.
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