From the Congressional Childhood Cancer Caucus–Concerns about Daunorubicin Shortage

Caucus Asks Questions about the Ongoing Shortage of Daunorubicin

WASHINGTON, D.C. – Out of concern over the ongoing shortage of daunorubicin, an essential therapy in the treatment of leukemia in children, Representatives McCaul and Van Hollen, the co-chairs of the Congressional Childhood Cancer Caucus, sent letters to the Food and Drug Administration  (FDA) and Teva Pharmaceuticals, the sole remaining supplier of the drug.
As of this summer, Teva Pharmaceuticals was the sole remaining supplier of the drug. Teva recently informed the FDA that the drug was in limited supply and that it would not return to full production until sometime next year. The FDA website does not list a reason for the shortage, leaving providers little additional information to estimate the potential scope of the disruption.
Members of the American Society of Pediatric Hematology-Oncology report that hospitals are quickly exhausting their remaining supply of daunorubicin, with some institutions having only a few weeks of supply or only enough supply for one more patient. The Children’s Oncology Group (COG) is currently conducting clinical trials for children with leukemia that includes daunorubicin, a cornerstone of curative AML treatment, as part of protocols. As a result of the shortage, for children and families who want to participate in clinical research, COG policy now requires the first course of daunorubicin be fully available at the treating hospital before allowing a child to be enrolled. Some children have now been prevented from enrolling due to the shortage.
Despite the passage of needed reforms related to drug shortages in the Food and Drug Administration Safety and Innovation Act of 2012, shortages of essential drugs remain a serious problem in the United States. Congress and the Executive Branch must continue to work to identify and address the underlying causes of drug shortages so that we may prevent future instances that put patients at risk.
Copies of the letters can be read by clicking on the attachments at the bottom of this webpage.