Bipartisan Letter Asks FDA About Cisplatin Imports, Addressing Root Causes of Shortages
Sen. Raphael Warnock, D-Ga., Rep. Buddy Carter, R-Ga., a pharmacist, and seven others of the 14 House members representing Georgia are asking the FDA how it is ensuring that chemotherapy drugs that are imported meet safety standards, given that Qilu Pharmaceuticals is not FDA-approved. FDA turned to Qilu for cisplatin after Intas Pharmaceuticals in India was shut down for contamination prevention issues. It had been supplying about half of U.S. cisplatin.
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
The members of Congress sent a letter that they publicized on Aug. 28. They wrote: "We are glad that the FDA is taking actions to mitigate these drug shortages. This includes working with additional manufacturers to increase supplies of these drugs. However, we are concerned by the lack of transparency from the FDA about these suppliers, especially since the FDA has begun importing cisplatin injections from Qilu Pharmaceutical, which is not FDA-approved and manufactures the injections in China. We are also alarmed by the lack of timeline and detail on when any new, safe imports of carboplatin will begin and from where they will be imported."
The members noted that the closure caused a chain reaction, as doctors prescribe other chemotherapy drugs, which then become scarce.
They asked: "What is the status of the FDA’s engagement with additional drugmakers outside of Qilu Pharmaceuticals regarding importing chemotherapy drugs?
"What is the FDA doing to resolve shortages of other chemotherapy drugs outside of carboplatin and cisplatin?
"How can Congress address the root causes of drug shortages, particularly those affecting chemotherapy drugs so that in the future, the closure of one manufacturing plant will not affect half of the U.S. supply of a critical drug?"