Senator seeks FDA fix to chemo drug shortage
Some cancer therapies--like certain anesthesia drugs--remain so scarce that those who administer them are scrambling for supplies. And Sen. Amy Klobuchar (D-MN) wants the FDA to fix the problem. Pronto.
Manufacturing and regulatory matters are at least partly the cause of both drug shortages, which have resulted in treatment delays and dosage cuts as well as delays in death penalty executions. Current pharma downsizing and business conditions are another cause.
But Klobuchar wants the FDA to act now: "I urge the FDA to find an immediate solution to the shortage of chemotherapy drugs, and to address the long-term challenges." She says in a letter to FDA Commissioner Margaret Hamburg that the agency could immediately "allow importation of certain products into the U.S. if that's an issue. And I'm talking about safe places like Canada."
Generics-maker Teva is one chemo drug supplier currently on the sidelines. It shut down for remediation a California plant that makes injectable drugs following an FDA warning letter for GMP violations. Chemotherapy drugs doxorubicin and etoposide are made at that plant. Teva says it expects to resume production of the chemo drugs in early 2011.
Teva's production halt left other U.S. manufacturers swamped and unable to keep up. Big 3 wholesaler AmerisourceBergen has implemented a fair-use policy to guide chemo drug distribution and prevent hoarding.
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