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FDA mulls overseas chemotherapy imports

WINDSOR, ON – MAY 8: Registered Pharmacy Technician Dawn Deslippe carefully labels Diane’s dose of carboplatin, one of two chemotherapy drugs she will receive during this visit. Each step of the process involves the verification of at least two people. The hospital now mixes the chemotherapy drugs themselves rather than having them pre-mixed. Diane Marley, 48, has cancer at Windsor Regional Hospital. She was diagnosed with breast cancer in December. She is finishing her chemo regimen within the next few weeks. She is one of hundreds of cancer patients across Ontario who have received dilute chemotherapy over the past year and are still undergoing treatment to defeat the disease. (Richard Lautens/Toronto Star via Getty Images)

Richard Lautens | Toronto Star | Getty Images

The Food and Drug Administration – facing a nationwide shortage of more than a dozen cancer drugs – is considering allowing the temporary importation of chemotherapy drugs from foreign manufacturers that are currently not authorized for distribution in the United States. United, a spokesperson for the agency told CNBC.

The FDA has not specified which manufacturers would be potential candidates to allow temporary importation of these drugs until approved manufacturers are able to meet patient needs.

But, “in these cases, we very carefully assess the quality of the foreign product, making sure it’s safe for US patients,” the spokesperson said.

In the past, the FDA has taken similar steps to ease import restrictions in the face of drug shortages. In the summer of 2022, the FDA allowed the importation of infant formula from manufacturers not approved by the agency when there was a severe shortage of infant formula in the United States.

The American Society of Clinical Oncology expects shortages to continue through June but will ease after that, particularly if the FDA lifts import restrictions, according to Dr. Julie Gralow, chief medical officer for that group.

“We hope and estimate that once we get through the next month we will have a more stable supply,” Gralow said.

At least 14 cancer drugs are currently in short supply in the United States

But doctors at hospitals across the country say the situation is particularly dire for two drugs – cisplatin and carboplatin – because they are so fundamental and widely used in the treatment of cancer.

The World Health Organization has stated that cisplatin and carboplatin are essential for basic health care.

Intas Pharmaceuticals, one of the largest makers of these drugs, has temporarily halted production and it is unclear when the company will resume manufacturing.

According to the National Cancer Institute, up to 20% of cancer patients rely on platinum-based chemotherapy drugs such as cisplatin and carboplatin for treatment.

And more than 100,000 Americans have been diagnosed in 2022 with cancers that can be treated with carboplatin or cisplatin, generic drugs that have been on the market for decades, according to the American Society of Clinical Oncology.

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 expand their supply and prioritize patients who would benefit most from treatment.

Some cancer patients could die if the shortages are not quickly resolved, doctors have said.

“Lawmakers across the country need to understand that this is a big deal at this point, where unless something changes in the next few weeks, it can lead to a great national emergency from a patient perspective and health care,” said Dr Abdul. Rafeh Naqash, a physician at the Stephenson Cancer Center at the University of Oklahoma.

Naqash said his facility is on the verge of running out of carboplatin. He said the shortages are a national security issue that must be addressed quickly.

“Things have gotten worse on the ground. Something has to happen and change immediately,” said Naqash, a lung cancer specialist.

He said he recently had to inform a patient that he would not be receiving carboplatin due to the shortage.

Such conversations will likely become more common in the coming weeks if help does not come, Naqash said.

Naqash said he does not understand why the United States does not have a national stockpile of these drugs to fill the void in emergency situations.

Philip Schwieterman, director of oncology and infusion services at the University of Kentucky Health System, said: “If I go to the grocery store and want a kiwi, there are usually kiwis there. .”

“It just crosses my mind that if I want cisplatin, I can’t get cisplatin even though it saves lives,” Schwieterman said.

“A cascading drug shortage”

The cisplatin and carboplatin shortages stem from the temporary halt in manufacturing for the US market at a facility in India run by Intas Pharmaceuticals.

Intas decided to halt manufacturing after an FDA inspection revealed a “cascade of failures” in the factory’s quality control unit late last year.

Intas, headquartered in Ahmedabad, India, distributes cisplatin and carboplatin in the United States through its subsidiary, Accord Healthcare.

When cisplatin shortages began in February, many patients switched to carboplatin, which is considered a sister drug, said Marc Phillips, who manages hospital pharmacy supply chain for WVU Medicine, the world’s largest drug system. West Virginia Health Care.

This shift has “led to what we consider to be a cascading drug shortage,” Phillips said.

“One shortage has now caused another,” he said.

Fresenius Kabi, Hikma Pharmaceuticals, Teva and Pfizer produce the drugs, but these companies have been unable to meet demand since the Intas factory closed.

Intas is working on a plan with the FDA to restart manufacturing.

But no date has been confirmed, company spokeswoman Emily King said.

When the plant restarts, production will prioritize drugs based on medical need, King said.

She noted that FDA drug shortage staff and the compliance office have identified carboplatin and cisplatin as a medical necessity for the US market.

The FDA spokesperson said Intas has begun releasing doses of cisplatin and carboplatin in the United States that were previously on hold due to a testing and verification process.

Ensuring the continued production of cancer treatments

Dr. Karen Knudsen, CEO of the American Cancer Society, said the shortages highlight a long-standing economic problem in the generic drug market.

Manufacturers are reluctant to invest more money in producing low-cost drugs like cisplatin and carboplatin, which leaves them vulnerable to shortages when a factory fails, Knudsen said.

Knudsen fears the United States will enter a cycle of cancer drug shortages if the federal government and industry don’t act together to address the problem.

“We need it to be financially viable for manufacturing to be able to produce effective and affordable cancer therapies,” she said.

Knudsen said demand for these drugs will increase in coming years as the population ages, as older people are at higher risk for cancer.

And drugs such as carboplatin and cisplatin use precious metals – platinum – which come largely from South Africa and Russia.

The World Platinum Investment Council predicts a major shortfall in the precious metal this year due in part to disruption in South Africa caused by a power shortage and operational problems in Russia due to sanctions following the invasion of Ukraine by the Kremlin.

Drugmakers are required to notify the FDA of manufacturing disruptions six months in advance or as soon as they can. Knudsen said the early warning system doesn’t seem to be working effectively.

“The fact that we’re sitting here right now talking about this shortage of cancers tells us that the early warning system hasn’t been activated soon enough, or that there aren’t enough manufacturers to be able to overcome the supply chain problem,” she said. .

A trio of Michigan Democratic lawmakers, Sens. Debbie Stabenow and Gary Peters, Rep. Elissa Slotkin, in a letter last month urged FDA Commissioner Dr. Robert Califf to “use all of his existing authorities to alleviate this serious shortage.”

The letter said Congress was working on long-term solutions to drug shortages, which have been a problem for years.

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