The Food and Drug Administration (FDA) is taking steps to alleviate the shortage of key chemotherapy treatments in the U.S. by allowing more cancer drugs from China. Specifically, the FDA has granted permission for 10 additional lots of the commonly used cancer drug cisplatin to be distributed by Qilu Pharmaceutical, a Chinese company. Cisplatin, along with another common cancer drug carboplatin, is currently experiencing a shortage. These drugs are typically prescribed together and are used to treat various types of cancer, including breast, lung, and prostate cancer.
The decision by the FDA was reported by Bloomberg and comes as a response to the ongoing shortage of chemotherapy medications. Previously, the FDA had issued a letter allowing the temporary importation of cisplatin with non-U.S. labeling, enabling the distribution of four lots of the drug. It should be noted that while cisplatin is commonly used in the U.S., the product being imported from Qilu, which is manufactured and marketed in China, does not have FDA approval.
The shortage of these cancer drugs is largely attributed to the temporary closure of a manufacturing facility in India owned by Intas Pharmaceuticals. The closure was a result of quality control issues identified by the FDA. However, Intas Pharmaceuticals is working with the FDA to resume production. To address the shortage, the FDA issued an import alert on the Indian facility, restricting the entry of products made there. However, 24 drugs, including cisplatin, are exempt from this restriction due to their scarcity.
This shortage has highlighted the fragile nature of drug supply lines in the U.S. Additionally, the lack of investment in generic drugs by manufacturers, as they have smaller profit margins, has contributed to the limited number of generic facilities operating at full capacity.
In conclusion, the FDA’s decision to allow more cancer drugs from China aims to address the ongoing shortage of chemotherapy treatments. However, it is important to note that the imported drugs do not have FDA approval. The shortage is primarily due to the temporary closure of a facility in India and the lack of investment in generic drugs by manufacturers. The tenuous nature of drug supply lines in the U.S. has been exposed by this shortage.
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