As the world’s largest professional society concerned with the causes and treatment of blood disorders, many of our 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).
The Food and Drug Administration (FDA) reported that two manufacturers plan additional releases within the week of February 20th, 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.
The Society is also submitting comments this week to the FDA concerning its Interim Final Rule, issued in response to the President’s Executive Order of Oct. 31, 2011, to enable the FDA to improve its collection and distribution of drug shortage information.
The steps the Society has taken over the past year have had impact. Following the introduction of bills in the House and Senate last year (S. 296/H.R.2245, the Preserving Access to Life-Saving Medications Act) mandating early notification by manufacturers of drugs in short supply, ASH was the first medical society to call on Congress to conduct hearings and has made recommendations on ways to prevent and mitigate drug shortages that are being incorporated into legislative and regulatory proposals.
ASH will continue to monitor all hematologic drug shortages closely and will continue to work with policy makers to protect the health of Americans.