FDA considers temporary cancer drug imports from unapproved companies to ease U.S. shortage

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Shortages of cisplatin and carboplatin, bedrock cancer treatments, have forced some hospitals to ration the drugs.

medications – is considering allowing the temporary importation of chemotherapy drugs from overseas manufacturers that are not currently approved to distribute in the United States, an agency spokesperson told CNBC.

"We're hoping and estimating that once we get through the next month that we will have a more stable supply," Gralow said.But doctors at hospitals around the country say the situation is particularly acute for two drugs — cisplatin and carboplatin — because they are so fundamental and widely used in cancer treatment.

Those drugs are used to treat a wide range of diseases including testicular, ovarian, breast, lung, bladder and head-and-neck cancers. He said he recently had to inform a patient that they will not receive carboplatin due to the shortage. "It boggles my mind that if I want some cisplatin, I can't get cisplatin even though it saves lives," Schwieterman said.The cisplatin and carboplatin shortages stem from the temporary shutdown of manufacturing for the U.S. market at a plant in India run by Intas Pharmaceuticals.in the facility's quality control unit late last year.

The FDA spokesperson said Intas has begun releasing into the U.S. doses of cisplatin and carboplatin that were previously on hold due to a testing and verification process.Dr. Karen Knudsen, CEO of the American Cancer Society, said the shortages highlight a long-standing economic problem in the generic drug market.

Knudsen said demand for these drugs will increase in the coming years as the population ages because older individuals are at higher risk for cancer.

 

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