Despite a lack of essential cancer medications, the FDA approves additional chemotherapy imports from China’s Qilu Pharmaceutical

Despite a lack of essential cancer medications, the FDA approves additional chemotherapy imports from China's Qilu Pharmaceutical

The ongoing shortage of crucial chemotherapy drugs in the United States has led the FDA to import a supply from China. In addition to the four lots of cisplatin previously approved for import in May, the FDA has now cleared an additional 10 lots from Chinese company Qilu Pharmaceuticals. The drugs will be distributed by Apotex, a Canadian company, and are expected to arrive in the US this week. Apotex is pleased to contribute to addressing the shortage.

Cisplatin and carboplatin, both platinum-based chemotherapies, are commonly used in various cancer treatments. The shortage began after the FDA identified quality issues at a facility producing cisplatin, causing disruptions across the supply chain. The shortage has been worsened by the pharmaceutical industry’s failure to invest in expanding production capacity.

– Richard Pazdur, M.D., Chief of the FDA’s Oncology Center of Excellence

The impact of the shortage has been felt by patients and oncologists nationwide. A survey conducted by the National Comprehensive Cancer Network in May revealed that 93% of surveyed cancer treatment centers had a shortage of carboplatin, while 70% reported a shortage of cisplatin. Hospitals have been forced to make difficult decisions regarding treatment prioritization.

Although the FDA is taking measures to address the issue, such as allowing India’s Intas Pharmaceuticals to continue shipping chemotherapies despite previous manufacturing deficiencies, Pazdur emphasizes that the agency alone cannot solve the problem. The FDA carefully assesses the quality of imported products during temporary importations.

The agency “very carefully” assesses product quality when accepting temporary importations. The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages.” 

FDA Commissioner Robert Califf, M.D

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