FDA allows import of unapproved China chemo med
Worker labors on a production line at factory of Qilu Pharmaceutical (Hainan) Co Ltd on February 11, 2022 in Haikou, Hainan Province of China.
The Food and Drug Administration has authorized the temporary importation of an unapproved chemotherapy drug from China in an effort to ease an acute shortage of cancer drugs in the United States, according to an update posted to the agency's website on Friday.
Qilu Pharmaceutical, which makes and markets cisplatin injections in China, received FDA permission to export that drug to the U.S. market weeks ago, a document shows.
A letter dated May 24 from Qilu's deputy general manager notified health-care professionals of the approval.
Qilu is coordinating with a Toronto-based company, Apotex, to distribute 50-milligram cisplatin vials in the U.S.
Health-care providers can begin ordering the drug on Tuesday through their wholesalers.
Cisplatin is a generic drug that has been available for decades in the U.S. and is distributed by several approved manufacturers. Those manufacturers have been unable to keep up with demand. Qilu's version of cisplatin is not approved in the U.S.
Qilu, which is headquartered in the city of Jinan in Shandong province, says it is one of the 10 largest drug manufacturers in China.
The FDA told CNBC this week that the agency was considering imports of unapproved chemotherapy drugs. But it did not at that time disclose the names of any manufacturers who might provide that medication.
An FDA spokesperson said the agency assesses the quality of unapproved drug imports to make sure they are safe for U.S. patients.
Doctors say some cancer patients could die if the national shortage drugs like cisplatin is not resolved soon. At least 13 other cancer drugs are in short supply across the U.S.
Source: CNBC
