A drug that is the “backbone” of chemotherapy will be imported from China into the United States, the Food and Drug Administration (FDA) has announced.
The cisplatin used by one in five cancer patients has been in shortage since February, due to the closure of a major supplier.
This drug, which has a 90% cure rate for testicular cancer, treats many types of diseases affecting the bladder, cervix, ovaries, lungs, breasts, and head and neck.
To shore up dwindling inventories, the FDA has approved a company based outside Beijing to manufacture and supply doses.
The agency also plans to approve a new supplier for another chemotherapy drug, carboplatin, which has been in shortage since late April.
Nearly two dozen chemotherapy drugs are in short supply nationwide due to a nationwide drug shortage, forcing many doctors to opt for alternatives that may be less effective.
The FDA has approved the import of stocks of the chemotherapy drug cisplatin produced near Beijing (stock)
The FDA revealed last week that it approved Qilu Pharmaceuticals to begin supplying cisplatin in the United States.
The doses will be supplied in 50-milligram vials labeled in Chinese and will be distributed by Canadian company Apotex, with deliveries expected to begin within weeks.
Cisplatin is one of the best chemotherapy drugs available, with Johns Hopkins oncologist Dr. Amanda Fader telling CNN that it is “the backbone of chemotherapy.”
In announcing the deal, FDA Commissioner Dr. Robert Califf, said, “We have taken steps to temporarily import certain approved overseas versions of cisplatin products from FDA-registered facilities.
‘[We’ve] used regulatory discretion to provide continued supply of other cisplatin and carboplatin products to help meet patient needs.’
He added: ‘In these situations, we evaluate product quality very carefully and require companies to take certain steps to ensure that products are safe for patients.
“The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs.”
The US cisplatin shortage erupted when Indian supplier Intas Pharmaceuticals, a major producer, was shut down after failing an inspection.
The inspection was called a “textbook example of what not to do when investigators come knocking,” after the FDA shut down the facility saying it found shredded papers and acid-soaked trash cans at the facility.
This quickly triggered a shortage, with most drug makers already running at full capacity unable to cope with the shortfall.
The United States will begin importing doses of the chemotherapy drug cisplatin from China to help ease shortages. It is administered to patients intravenously
It has led regulators in the United States to turn to China for assistance, which is the country’s fourth-largest drug supplier.
There are concerns in some policy circles that China may weaponize these drugs against America to gain concessions.
Rosemary Gibson, senior adviser on health issues at a New York-based think tank, previously said: “Medicines can be weaponized against the United States.
“Supplies can be withheld. Medicines can be made with lethal contaminants or sold without any real medicine in them, rendering them ineffective.’
Dr. Fader said the shortage has forced doctors to start replacing cisplatin with other drugs.
“In many cases, these drug substitutions will be just as effective in terms of treatment response,” he said.
“However, many of these drugs may have worse side effect profiles or different dosing schedules that require two to three times longer dosing times.”
The FDA also resorted to drug imports last year due to shortages of the chemotherapy drug Doxil, which can be used to treat ovarian and breast cancer.
Cisplatin works by interfering with the DNA of cancer cells to trigger their death, helping to eliminate the disease from the body.
It is typically given intravenously by healthcare professionals, and patients can be on treatment for weeks at a time.
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