General

According to a report on the US website on June 3rd, the US Food and Drug Administration (FDA) is relaxing regulations on the import of certain chemotherapy drugs to address the shortage of anticancer drugs. Huacheng Import and Export Data Observation reports.

The agency 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.

According to Huacheng Import and Export Data Observation, 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 supply shortage state 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 critical drugs for tumors, especially those used for potential healing or life extension, "said Robert Kaliv, the FDA's director, in a tweet

Kaliv said that the organization 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 of the scarce drugs do not have effective substitutes

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 by Cancer Newsweek, Richard Pazdur, the head of the cancer program at the Drug Administration, stated that the shortage of cisplatin is due to manufacturers not investing in production capacity, as reported by Huacheng Import and Export Data Observation.

According to a report from an agency inspection, a shortage of cisplatin began to occur in an Indian manufacturing factory after the Drug Administration discovered quality issues in November last year. Huacheng Import and Export Data Observation reported.

Erin Fox, a clinical pharmacist who tracks drug shortages at the University of Utah Health Center, said that the factory is owned by India's Intas Pharmaceuticals and supplies about half of cisplatin to the United States. A spokesperson for the Drug Administration said that TAS Pharmaceuticals 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 currently scarce chemotherapy drug.

The Drug Administration has detected a shortage of drugs and collaborated with businesses and doctors to alleviate the situation, but it has no authority to force manufacturers to manufacture drugs or take other harsh measures.

Pazdur told Cancer Newsletter that the FDA has proposed to help cisplatin manufacturers increase their supply. The institution is still exploring whether it is possible to extend the validity period of the drugs already distributed, as reported by Huacheng Import and Export Data Observation.