FDA weighs importation of chemo drugs from unapproved manufacturers amid shortage

The FDA is deciding whether to temporarily allow the importation of chemotherapy drugs from unapproved manufacturers outside of the U.S. as the nation grapples with a shortage of key cancer drugs, a spokesperson with the agency told CNBC June 1. 

Last summer, the agency took a similar action to address the baby formula shortage. 

"In these cases, we very carefully assess the overseas product for quality, making sure that its [sic] safe for U.S. patients," a spokesperson told the news outlet. 

Physicians and patients have been especially concerned about a shortage of cisplatin and carboplatin, which has in some cases led oncologists to ration the widely used cancer drugs and delayed patient treatment. 

"Things have been getting worse on the ground. Something has to happen and change immediately," Abdul Rafeh Naqash, MD, a lung cancer specialist at the OU Health Stephenson Cancer Center in Oklahoma City, told CNBC

The cisplatin shortage began in early February. Since then, resupply dates have been pushed back four times. Drugmakers have said they anticipate their supply to return to normal levels in June. Oncology groups anticipate potential eased import restrictions would help further stabilize supplies after June, according to CNBC

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