Workers work on a production line at the Qilu Pharmaceutical Factory in Haikou, China’s Hainan Province, February 11, 2022.
Sue Bacon VCG | Getty Images
The US Food and Drug Administration has authorized the temporary import of an unapproved chemotherapy drug from China in an effort to ease an acute shortage of cancer drugs in the United States, according to an update posted on the agency’s website on Friday.
A document showed that Qilu Pharmaceutical, which manufactures and markets cisplatin injections in China, obtained the Food and Drug Administration’s permission to export the drug to the US market weeks ago.
A letter dated May 24 from Qilu’s deputy general manager notified healthcare professionals of the approval.
Qilu is coordinating with Toronto-based Apotex to distribute 50-milligram vials of cisplatin in the United States
Health care providers can start ordering the drug Tuesday through wholesalers.
Cisplatin is a generic drug that has been available for decades in the United States and is distributed by several approved manufacturers. These manufacturers could not keep up with demand. The Qilu version of cisplatin is not approved in the United States
Headquartered in Jinan, Shandong Province, Qilu says it is one of the top 10 pharmaceutical manufacturers in China.
The FDA told CNBC this week that the agency is considering importing unapproved chemotherapy drugs, but did not disclose at the time the names of any manufacturers that might supply the drug.
A spokesperson for the US Food and Drug Administration said the agency evaluates the quality of imports of unapproved drugs to ensure they are safe for American patients.
Doctors say some cancer patients could die if a national shortage of drugs like cisplatin is not resolved soon. There are shortages of at least 13 other cancer medications across the United States
Cancer drug shortages have forced some hospitals to ration drugs by reducing dosage to expand supply and prioritize patients with the best chance of recovery.
Cisplatin is widely used to treat cancers of the testicle, lung, bladder, cervix, and ovary, among other conditions. Up to 20% of cancer patients are treated with cisplatin and other platinum-based chemotherapy drugs, according to the National Cancer Institute.
The World Health Organization says medicine is an essential part of basic healthcare.
A national shortage of cisplatin began in February after a pharmaceutical company based in India temporarily halted production for the US market.
Intas Pharmaceuticals decided to pause production after last year the US Food and Drug Administration found a “chain of failures” in its quality control unit.
An Intas spokesperson told CNBC this week that the company is working with the Food and Drug Administration to bring the production back to the United States, but no date has been set yet.