Employee labors on a production line on 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 USA, in response to an update posted to the agency’s website Friday.
Qilu Pharmaceutical, which makes and markets cisplatin injections in China, received FDA permission to export the drug to the U.S. market weeks ago, a document shows.
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 within 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 many years within the U.S. and is distributed by several approved manufacturers. Those manufacturers have been unable to maintain up with demand. Qilu’s version of cisplatin shouldn’t be approved within the U.S.
Qilu, which is headquartered in town of Jinan in Shandong province, says it’s considered one of the ten largest drug manufacturers in China.
The FDA told CNBC this week the agency was considering imports of unapproved chemotherapy drugs, however it didn’t at the moment disclose the names of any manufacturers who might provide that medication.
An FDA spokesperson said the agency assesses the standard of unapproved drug imports to make sure that they’re secure for U.S. patients.
Doctors say some cancer patients could die if the national shortage of medication resembling cisplatin shouldn’t be resolved soon. Not less than 13 other cancer drugs are in brief supply across the U.S.
The cancer drug shortages have forced some hospitals to ration medications by reducing the dosage to increase the availability and prioritizing patients who’ve a greater likelihood of being cured.
Cisplatin is widely used to treat testicular, lung, bladder, cervical and ovarian cancers amongst other disease states. As much as 20% of cancer patients are treated with cisplatin and other platinum-based chemotherapy drugs, in response to the National Cancer Institute.
The World Health Organization says the drug is an important a 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 yr found a “cascade of failure” in its quality control unit.
A spokesperson for Intas told CNBC this week the corporate is working with the FDA to restart production for the U.S., but no date has been set yet.
