The FDA allows the import of unapproved Chinese chemotherapy drugs
Workers work on a production line at the Qilu Pharmaceutical factory in Haikou, east China’s Hainan province, 11 February 2022.
Su Bikun | vcg | Getty Images
The U.S. Food and Drug Administration has approved the temporary importation of an unapproved chemotherapy drug from China to help alleviate the acute shortage of cancer drugs in the United States, according to an update published on the agency’s website on Friday.
A document shows that Qilu Pharmaceutical, which makes and markets cisplatin injections in China, received FDA approval weeks ago to export the drug to the US market.
A May 24 letter from Qilu’s deputy general manager informed health workers of the approval.
Qilu is partnering with Toronto-based company Apotex to distribute 50-milligram vials of cisplatin in the United States
Healthcare providers can start ordering the drug through their wholesalers from Tuesday.
Cisplatin is a generic drug that has been available in the US for decades and is distributed by several licensed manufacturers. These manufacturers could not keep up with the demand. Qilu’s version of cisplatin is not approved in the United States
Qilu, headquartered in the city of Jinan in Shandong province, claims to be one of the ten largest drug manufacturers in China.
The FDA told CNBC this week that the agency is considering importing unapproved chemotherapy drugs, but at the time did not disclose the names of manufacturers who might offer those drugs.
A spokesman for the FDA said the agency assesses the quality of unapproved drug imports to ensure they are safe for US patients.
Doctors say some cancer patients could die if nationwide shortages of drugs like cisplatin aren’t fixed soon. At least 13 other cancer drugs are in short supply in the US
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Cancer drug shortages have forced some hospitals to ration drugs, reducing dosages to expand supplies and prioritizing patients with a better chance of recovery.
Cisplatin is commonly used to treat testicular, lung, bladder, cervical, and ovarian cancer, among others. 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 nationwide shortage of cisplatin 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 found a “cascade of errors” in its quality control unit.
A spokesman for Intas told CNBC this week that the company is working with the FDA to resume production for the US, but no date has been set.
