- The Food and Drug Administration has given Qilu Pharmaceutical permission to ship cisplatin to the United States to alleviate a national cancer drug shortage.
- A pharmaceutical company’s cisplatin injection is manufactured and sold in China. Cisplatin is widely used in chemotherapy to treat testicular, lung, bladder, cervical and ovarian cancer.
- The FDA earlier said it was considering allowing the importation of unlicensed drugs to alleviate shortages.
- Doctors say cancer patients could die if the shortage is not resolved soon.
Workers work on a production line at the Qilu Pharmaceutical (Hainan) Co., Ltd. factory in Haikou, China’s Hainan province, on February 11, 2022.
Su Bikun | VCG | Getty Images
of Food and Drug Administration It has reportedly allowed temporary imports of unapproved chemotherapy drugs from China to ease a severe shortage of cancer drugs in the United States. update It was posted on the agency’s website on Friday.
Qilu Pharmaceuticalto manufacture and sell Cisplatin Injected in China FDA Authorizations were obtained several weeks ago to export the drug to the U.S. market, according to documents.
A May 24 letter from Qilu’s deputy general manager notified the medical experts of the approval.
Qilu is coordinating with Toronto-based company Apotex to distribute 50-milligram vials of cisplatin in the United States.
Health care providers can start ordering the drug through wholesalers starting Tuesday.
Cisplatin has been available as a generic drug in the United States for decades and is marketed by several approved manufacturers. These manufacturers are unable to keep up with demand. Qilu’s version of cisplatin is not approved in the US
Qilu, headquartered in Jinan, Shandong Province, says it is one of China’s 10 largest pharmaceutical companies.
The FDA told CNBC this week that it is considering importing unapproved chemotherapy drugs. But at the time, it did not name a potential manufacturer of the drug.
An FDA spokesperson said the agency evaluates the quality of imports of unlicensed drugs to ensure they are safe for US patients.
Doctors say some cancer patients could die if nationwide shortages of drugs such as cisplatin are not resolved soon.At least 13 other anticancer drugs are in national shortage
Shortages of anticancer drugs have forced some hospitals to distribute drugs at lower doses to extend supply, prioritizing patients with a higher chance of cure.
Cisplatin is widely used to treat diseases such as testicular cancer, lung cancer, bladder cancer, cervical cancer, and ovarian cancer. 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 integral part of basic medical care.
A nationwide cisplatin shortage began in February after an India-based drugmaker suspended production for the U.S. market.
Intus Pharmaceutical decided to temporarily suspend production after an FDA inspection last year uncovered a “series of deficiencies” in its quality control department.
It’s unclear when Intus will resume producing drugs for the U.S. market.
A spokeswoman for Intas told CNBC this week that it is working with the FDA to resume production for the U.S., but has not yet set a date.
