USA — The United States is seeking to address the ongoing shortage of the chemotherapy drug cisplatin by importing additional doses from China.

The scarcity arose when an Indian pharmaceutical site voluntarily suspended operations after the FDA identified quality issues in a late 2022 inspection.

A spokesperson for the FDA has confirmed that the agency is permitting 10 additional lots of the common cancer drug cisplatin to be distributed by the Chinese company Qilu Pharmaceutical.

Cisplatin, a long-standing generic drug in the U.S., is produced by multiple approved manufacturers, yet they have struggled to meet the demand.

Although Qilu Pharmaceutical manufactures a version of cisplatin, it has not obtained FDA approval for use in the United States.

A spokesperson for Apotex, a generic medicine company distributing the Chinese-made drug in the U.S., stated that they are expecting 10 more batches of Qilu Pharmaceutical’s cisplatin to arrive from China later this week.

Qilu, one of China’s top ten drug manufacturers, is headquartered in Jinan, Shandong province.

Apotex’s spokesperson affirmed their commitment to collaborate with the FDA and their partner to ensure a continuous supply of these critical medications.

Val Jensen of the FDA explained that while five companies produce cisplatin, the Intas site accounted for the majority of the volume, making it challenging for competitors to quickly bridge the gap.

Jensen further emphasized the FDA’s efforts to prevent site closures and explore solutions, including the potential creation of new drug stockpiles.

The FDA cleared a version of Qilu’s cisplatin for entry into the U.S. market in June; however, it is important to note that this version is marketed in China but lacks FDA approval, as reported by the Institute for Safe Medication Practices (ISMP).

According to a letter from Qilu to U.S. healthcare professionals, there are some labeling differences in the imported version of the drug.

The shortage of cancer drugs has compelled hospitals to implement rationing measures such as reducing dosages and prioritizing patients with higher chances of cure.

Cisplatin is widely used in the treatment of various cancers, including testicular, lung, bladder, cervical, and ovarian cancers.

The National Cancer Institute estimates that up to 20% of cancer patients receive cisplatin or other platinum-based chemotherapy drugs, highlighting its crucial role in cancer care worldwide.

The World Health Organization recognizes cisplatin as an essential component of basic healthcare. Unfortunately, the national shortage of cisplatin originated in February when an Indian pharmaceutical company temporarily halted production for the U.S. market.

Intas Pharmaceuticals made this decision following an FDA inspection that revealed significant quality control issues within its operations.

While Intas Pharmaceuticals is collaborating with the FDA to resume production for the U.S. market, no specific timeline has been established yet.

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