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American Society of Hematology statement on critical methotrexate drug shortage
Date:2/15/2012

(WASHINGTON, February 15, 2012) - As the world's largest professional society concerned with the causes and treatment of blood disorders, many of ASH's more than 16,000 members are on the front lines of dealing with the country's severe shortage of methotrexate, a drug critical in the treatment of children with acute lymphocytic leukemia (ALL). This morning the Food and Drug Administration (FDA) reported that two manufacturers plan additional releases at the end of this week, at the end of February, and continuing into March, which it anticipates will meet all patient needs.

While the Society is pleased with this announcement, we realize the shortage is still critical at many sites throughout the country and urge the FDA to ensure that once supplies are available, hematologists can have information on how to access this therapy for their critically ill patients. ASH has been working hard to address the shortage, including reporting shortages to the FDA and Congress and urging the FDA to take immediate action to identify other manufacturers to meet demand, import supplies from overseas, and establish an emergency supply once there is a release so that supplies can be easily accessed.

Over the past year the Society has led collaborative efforts with the FDA, Congress, and senior health officials in the Administration to resolve not only this shortage, but also shortages of more than 200 other drugs, many of which are used to treat patients with hematologic diseases, that have become critical and life-threatening. This week the Society sent a letter of support to Representatives Larry Buscon (D-IN) and John Carney (D-DE) who introduced bipartisan legislation (H.R. 3839, the Drug Shortage Prevention Act) that would provide expedite FDA review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration (DEA) quotas for medications in short supply.
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Contact: Andrea Slesinski
aslesinski@hematology.org
202-552-4927
American Society of Hematology
Source:Eurekalert

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