FDA allows temporary import of unapproved Chinese cancer drug to ease U.S. shortage
Worker labors on a production line at the factory of Qilu Pharmaceutical in Haikou, Hainan province of China, February 11, 2022.
Su Bikun | VCG | Getty Images
The U.S. Food and Drug Administration has authorized the temporary importation of an unapproved chemotherapy drug from China in effort to ease an acute shortage of cancer drugs in the United States, according to an update posted to the agency’s website Friday.
A letter dated May 24 from Qilu’s deputy general manager notified health care professionals of the approval.
Qilu is coordinating with a Toronto-based company, Apotex, to distribute 50-milligram cisplatin vials in the U.S.
Health care providers can begin ordering the drug Tuesday through their wholesalers.
Cisplatin is a generic drug that has been available for decades in the U.S. and is distributed by several approved manufacturers. Those manufacturers have been unable to keep up with demand. Qilu’s version of cisplatin is not approved in the U.S.
Qilu, which is headquartered in the city of Jinan in Shandong province, says it is one of the 10 largest drug manufacturers in China.
The FDA told CNBC this week the agency was considering imports of unapproved chemotherapy drugs, but it did not at that time disclose the names of any manufacturers who might provide that medication.
An FDA spokesperson said the agency assesses the quality of unapproved drug imports to make sure they are safe for U.S. patients.
Doctors say some cancer patients could die if the national shortage of drugs such as cisplatin is not resolved soon. At least 13 other cancer drugs are in short supply across the U.S.
The cancer drug shortages have forced some hospitals to ration medications by reducing the dosage to extend the supply and prioritizing patients who have a better chance of being cured.
Cisplatin is widely used to treat testicular, lung, bladder, cervical and ovarian cancers among other disease states. 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 the drug is an essential part of basic health care.
The national shortage of cisplatin began in February after a pharmaceutical company based in India temporarily halted production for the U.S. market.
Intas Pharmaceuticals decided to temporarily stop production after an FDA inspection last year found a “cascade of failure” in its quality control unit.
A spokesperson for Intas told CNBC this week the company is working with the FDA to restart production for the U.S., but no date has been set yet.