FDA contemplating abroad chemotherapy imports

WINDSOR, ON – MAY 8: Pharmacy technician by training, Dawn Deslippe, carefully labels Diane’s dose of carboplatin, one of two chemo medications she will be given at this visit. Each step of the process requires verification by at least two people. The hospital now makes the chemo drugs themselves instead of having them pre-mixed. Diane Marley, 48, is a cancer patient at Windsor Regional Hospital. She was diagnosed with breast cancer in December. She will finish her chemotherapy in the next few weeks. She is one of hundreds of Ontario cancer patients who have received diluted chemotherapy in the last year and are still undergoing treatment to fight the disease. (Richard Lautens/Toronto Star via Getty Images)

Richard Lautens Toronto Star | Getty Images

The Food and Drug Administration — which is facing nationwide shortages of more than a dozen cancer drugs — is considering allowing temporary imports of chemotherapy drugs from foreign manufacturers that are not currently approved for distribution in the United States, a spokesman for the agency said to CNBC.

The FDA has not said 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 check the quality of the foreign product very carefully and make sure it’s safe for US patients,” the spokesman said.

The FDA has taken similar action in the past to ease import restrictions amid drug shortages. In the summer of 2022, the FDA allowed the import of baby formula from non-regulated manufacturers when there was a severe infant formula shortage in the United States

The American Society of Clinical Oncology expects shortages to continue through June, but will then ease, especially when the FDA lifts import restrictions, according to Dr. Julie Gralow, the chief physician of this group.

“We hope and expect to have a more stable supply by the end of next month,” Gralow said.

At least 14 cancer drugs are currently in short supply in the US

But doctors in hospitals across the country say the situation is particularly acute with two drugs — cisplatin and carboplatin — because they’re so important and widely used in cancer treatment.

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

Intas Pharmaceuticals, one of the largest manufacturers of these drugs, has temporarily halted production and it is not clear when the company will resume production.

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

And more than 100,000 Americans will be diagnosed in 2022 with cancer treatable with carboplatin or cisplatin, generic drugs that have been on the market for decades, the American Society of Clinical Oncology says.

These drugs are used to treat a variety of diseases, including testicular, ovarian, breast, lung, bladder, and head and neck cancer.

Drug shortages have forced some hospitals to ration drugs, reducing doses to expand their supplies and prioritizing patients who would benefit most from treatment.

Some cancer patients could die if the shortage isn’t fixed quickly, doctors said.

“Legislators in the country need to understand that this is a big problem at this point. If nothing changes in the next few weeks, it could create a major national emergency from a patient and healthcare perspective,” said Dr. Abdul Rafeh Naqash, a physician at the University of Oklahoma’s Stephenson Cancer Center.

Naqash said his facility was close to running out of carboplatin. He said the shortages are a national security issue that must be addressed quickly.

“It’s getting worse locally. Something has to happen and change immediately,” said Naqash, who specializes in lung cancer.

He said he recently had to tell a patient that he would not receive carboplatin due to the deficiency.

Such talks are likely to occur more frequently in the coming weeks barring relief, Naqash said.

Naqash said he doesn’t understand why the US doesn’t have a nationwide stockpile of these drugs to fill the gap 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 I want a kiwi, they usually have kiwis.”

“It baffles me that if I want some cisplatin, even though it saves lives, I can’t get cisplatin,” Schwieterman said.

“A cascading drug shortage”

The shortages of cisplatin and carboplatin are due to the temporary closure of production for the US market at a plant in India operated by Intas Pharmaceuticals.

Intas decided to halt production after an FDA inspection late last year found a “cascade of errors” in the plant’s quality control unit.

Headquartered in Ahmedabad, India, Intas 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 leads the in-patient pharmacy supply chain for WVU Medicine, West Virginia’s largest health care system.

That shift has “resulted in what we think are cascading drug shortages,” Phillips said.

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

Fresenius Kabi, Hikma Pharmaceuticals, Teva and Pfizer make the drugs, but these companies have not been able to keep up with demand since the Intas plant shut down.

Intas is working with the FDA on a plan to resume production.

However, a date has not yet been confirmed, said company spokeswoman Emily King.

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

She noted that FDA’s drug shortage staff and Office of Compliance have identified carboplatin and cisplatin as medical necessity for the US market.

The FDA spokesman said Intas has begun releasing doses of cisplatin and carboplatin into the United States that were previously on hold pending a testing and verification process.

Ensuring the production of cancer treatments continues

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 making low-cost drugs like cisplatin and carboplatin, making them vulnerable to shortages if a factory goes down, Knudsen said.

Knudsen worries that unless the federal government and industry work together to solve the problem, the US will fall into a vicious cycle of cancer drug shortages.

“We need financially viable manufacturing to make effective and affordable cancer therapies,” she said.

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

And drugs like carboplatin and cisplatin use precious metals — platinum — mostly sourced in South Africa and Russia.

The World Platinum Investment Council is forecasting a large deficit in the precious metal this year, due in part to disruptions in South Africa due to power shortages and operational problems in Russia due to sanctions over Ukraine’s Kremlin invasion.

Drug manufacturers are required to notify the FDA of production stoppages six months in advance or as soon as they are able. Knudsen said the early warning system does 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 soon enough or there aren’t enough manufacturers to address the supply chain problem,” she said.

The FDA is working with the company to increase supply to meet patient demand, the agency’s spokesman said.

A trio of Democratic lawmakers from Michigan, Sen. Debbie Stabenow and Gary Peters, Rep. Elissa Slotkin, wrote in a letter last month calling on FDA Commissioner Dr. Robert Califf to “use all existing authorities to mitigate this serious deficiency”.

The letter said Congress was working on long-term solutions to the drug shortage that has been a problem for years.

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