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FDA allows import of unapproved Chinese chemo drugs

A worker works on a production line at Qilu Pharmaceutical’s factory in Haikou, China’s Hainan province, Feb 11, 2022.

Su Bikun | CGV | Getty Images

The U.S. Food and Drug Administration has authorized the temporary importation of an unapproved chemotherapy drug from China in an effort to alleviate an acute shortage of cancer drugs in the United States, according to an update. day posted Friday on the agency’s website.

Qilu Pharmaceutical, which manufactures and markets cisplatin injections in China, received clearance from the FDA a few weeks ago to export the drug to the US market, according to a document.

A letter dated May 24 from Qilu’s deputy general manager informed medical professionals of the approval.

Qilu is coordinating with a Toronto-based company, Apotex, to distribute 50-milligram vials of cisplatin in the United States

Healthcare providers can start ordering the drug Tuesday from their wholesalers.

Cisplatin is a generic drug that has been available for decades in the United States and distributed by several licensed manufacturers. These manufacturers were unable to meet demand. Cisplatin version of Qilu is not approved in the United States

Qilu, headquartered in Jinan city, Shandong province, claims to be one of the top 10 drugmakers in China.

The FDA told CNBC this week that the agency was considering importing unapproved chemotherapy drugs, but it did not release at that time the names of manufacturers who might supply the drug.

An FDA spokesperson said the agency assesses the quality of imports of unapproved drugs to ensure they are safe for American patients.

Doctors say some cancer patients could die if the nationwide shortage of drugs such as cisplatin is not resolved soon. At least 13 other cancer drugs are in short supply in the United States

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Cancer drug shortages have forced some hospitals to ration drugs by reducing dosage to expand supply and prioritizing patients who have a better chance of recovery.

Cisplatin is widely used to treat cancers of the testicles, lungs, bladder, cervix, and ovaries, among other disease states. According to the National Cancer Institute, up to 20% of cancer patients are treated with cisplatin and other platinum-based chemotherapy drugs.

The World Health Organization says the drug is an essential part of basic health care.

The national cisplatin shortage began in February after an India-based pharmaceutical company temporarily halted production for the US market.

Intas Pharmaceuticals decided to temporarily halt production after an FDA inspection last year revealed a “cascade of failures” in its quality control unit.

A spokesperson for Intas told CNBC this week that the company was working with the FDA to restart production in the United States, but no date has yet been set.

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