The U.S. Food and Drug Administration (FDA) is importing more cancer drugs from China because of the ongoing shortage of cancer treatments. Ten additional lots of a cisplatin product will be permitted to be distributed by Qilu Pharmaceutical. Before the approval of these additional lots, the FDA approved the distribution of four lots.
Although cisplatin is FDA-approved and is used commonly in the U.S., the cisplatin product to be imported from China is not FDA-approved.
Importation of the product is intended to address the cisplatin shortage in the U.S., which is primarily the result of the temporary closure of an Intas Pharmaceuticals-owned manufacturing facility in India. Issues with quality control were discovered at the facility, leading to the closure. The facility is expected to reopen but is working with the FDA to resolve the issues.
These quality control issues created a cascading effect in the supply of cisplatin, which has forced physicians to decide which patients can receive treatment.
Another factor contributing to the shortage is little investment in generic treatments, given their smaller profit margins for drug manufacturers. Without this investment, very few generic manufacturing facilities can operate at full force. A lack of investment in building production capacity has also made the problem worse.