Beijing, 8 July 2023 (TDI): The U.S. Food and Drug Administration (FDA) collaborated with China Qilu Pharmaceutical amid a shortage of cancer drugs in the US. The purpose of the collaboration was to import the drug maker’s generic cancer treatment, cisplatin.
Qilu Pharmaceutical‘s cisplatin injections, manufactured and marketed in China, have not obtained FDA approval in the United States until it received permission to export its drug to the American market in late May, as indicated by a document. This approval comes in response to a growing shortage of cisplatin, which poses a potential risk to the survival of numerous cancer patients in the U.S.
Moreover, FDA Commissioner Dr Robert Califf said, “We’ve taken steps for the temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs.”
In November, the scarcity of cisplatin in the United States became a pressing issue when inspectors from the U.S. identified significant issues at Intas Pharmaceuticals in India. Intas Pharmaceuticals had been a major supplier, responsible for producing more than half of the U.S. supply of this crucial generic cancer treatment.
It is important to note that, the production of cisplatin is a complex process that involves the use of platinum metal. It requires a sterile production environment and strict measures to protect the safety of lab workers.
To add further, the shortage of cisplatin is not the only case. There are currently over 130 drug formulations experiencing shortages in the United States, according to the FDA’s maintained list. This situation also highlights the challenges faced in ensuring a steady supply of essential medications for patients in the country.