The United States "bows its head": allows the import of a chemotherapy injection from Qilu Pharmaceutical, but there is a severe shortage of anti-cancer drugs in factories | Drug | United States
According to the Wall Street Journal website on June 3rd, the US Food and Drug Administration is relaxing regulations on importing certain chemotherapy drugs to address the shortage of anti-cancer drugs.
The institution stated that it will allow Chinese pharmaceutical company Qilu Pharmaceutical to ship a chemotherapy injection called cisplatin to the United States, although the product has not yet been approved by the Drug Administration and the bottle is labeled in Chinese.
The US Food and Drug Administration also announced on the 2nd that it will allow an Indian factory that has temporarily suspended production due to production violations to resume exporting certain anti-cancer drugs to the United States, as long as the latter meets conditions such as third-party certification of their quality.
The institution stated that it will also flexibly increase the supply of other cisplatin products and chemotherapy drugs.
▲ Data image: Workers are working on the formulation production line at the Jinan High tech Formulation Branch of Qilu Pharmaceutical Co., Ltd.
According to reports, cisplatin is a widely used chemotherapy drug. According to data from the National Cancer Institute in the United States, 10% to 20% of all cancer patients use this drug for treatment.
Cisplatin is also used to treat lung cancer, bladder cancer cancer, cervical cancer and ovarian cancer. According to data from the Drug Administration, it has been in a state of supply shortage since February.
The report states that in recent months, doctors have had to administer some cancer drugs.
"The FDA recognizes the importance of stable and safe supply of key drugs for cancer, especially those used for potential healing or life extension," said Robert Kalif, the director of the FDA, in a tweet
Kalif said that the institution will ensure that the products used during the shortage period are safe for patients.
Karen Knudsen, CEO of the American Cancer Society, said last month, "The shortage of certain anti-cancer drugs has become a serious and life-threatening problem faced by cancer patients nationwide. Many scarce drugs lack effective alternatives."
According to the American Society of Clinical Oncology, the shortage of cisplatin supply intensified in late March and early April.
In a recent interview published in Cancer Newsweek, Richard Pazdur, the head of the FDA's cancer program, stated that the shortage of cisplatin is due to manufacturers not investing in production capacity.
According to a report from an institutional inspection, a shortage of cisplatin began to occur in an Indian manufacturing factory after the National Medical Products Administration discovered quality issues in November last year.
Clinical pharmacist Erin Fox from the University of Utah Health Center, who tracks drug shortages, said that the factory is owned by Indian company Inntas Pharmaceuticals and supplies about half of cisplatin to the United States. A spokesperson for the Drug Administration said that TASS Pharmaceutical Company has shut down the production of cisplatin and a similar drug called carboplatin at the factory. Fox said that other pharmaceutical companies are unable to fill this gap, which has prompted many doctors to use carboplatin, another chemotherapy drug that is currently in short supply.
The Drug Administration has detected a shortage of drugs and collaborated with businesses and doctors to alleviate this situation, but it has no authority to force manufacturers to manufacture drugs or take other harsh measures.
Pazdour told Cancer Communications that the FDA has proposed to help cisplatin manufacturers increase their supply. The organization is still exploring whether it is possible to extend the validity period of the drugs already distributed.
