The Food and Drug Administration (FDA) is opening the way for more cancer drugs from China as the U.S. continues to deal with an ongoing shortage in key chemotherapy treatments.
A spokesperson for the FDA confirmed on Monday that the agency is permitting 10 additional lots of the common cancer drug cisplatin to be distributed by the Chinese company Qilu Pharmaceutical.
Cisplatin is currently under shortage along with another common cancer drug carboplatin. These two drugs, oftentimes prescribed together, are used to treat a wide variety of cancers such as those of the breast, lung and prostate.
The latest move was first reported by Bloomberg.
The FDA last month issued a letter allowing the “Temporary Importation of CISplatin Injection with non-U.S. Labeling” in order to address the shortage of chemotherapy medications. At the time, four lots were allowed to be distributed.
While cisplatin is a commonly used drug in the U.S., the cisplatin product being imported by Qilu — manufactured and marketed in China — is not FDA-approved.
Much of the current shortage is tied to the temporary closure of a manufacturing facility in India owned by Intas Pharmaceuticals. The closure occurred after the FDA discovered “failures” in the plant’s quality control. The company is working with the FDA to restart production.
Last month, the agency issued an import alert on the facility in India which would deny entry for all products made at that location except 24 drugs that are in short supply, including cisplatin.
The current shortage has brought heightened attention on the tenuous nature of drug supply lines for medicines in the U.S.
The shortage is also partly due to drug manufacturers lacking an incentive to invest in generic drugs, which have smaller profit margins. This has lead to a limited number of generic facilities operating at near-capacity.
