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FDA Advisory Panel to Weigh in on Dosing of Anemia Biologics to Kidney Patients

www.biologicdrugreport.com

The Food and Drug Administration staff will ask an independent panel of experts on Sept. 11th for input to help it establish the proper dosing range for administering anemia biologics to patients with end-stage kidney disease.

In March, after reports indicated some doctors used Aranesp, Epogen and Procrit to increase red blood cell counts to unsafe levels, the FDA added a "black box" warning recommending the drugs be used at the lowest dose needed to boost red blood cell levels to the lowest level necessary to avoid transfusions.

But a battle continues to rage over what this minimum level should be.

In July, the Medicare program set its own guidelines for cancer patients suffering from anemia, saying it would not pay for the anemia biologics until a patient's hemoglobin drops below 9 grams per deciliter of blood.

A month later, in response to a public outcry contending the guidelines went too far and would reduce patients' quality of life, Medicare said it would would allow doctors to begin treatment for anemia caused by chemotherapy when hemoglobin falls below 10 grams per deciliter.

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