(WASHINGTON) - Today the FDA took two critical steps toward preventing and resolving drug shortages, releasing a strategic plan on drug shortages and issuing a proposed rule requiring manufacturers to notify the agency of a permanent discontinuance or temporary interruption in the production of medically important prescription drugs. ASH, the world’s largest professional society concerned with the causes and treatment of blood disorders, represents more than 14,000 members who specialize in blood cancers such as leukemia, lymphoma, and myeloma, as well as serious blood diseases such as hemophilia. The country’s recent spate of drug shortages has particularly affected ASH member hematologists and their patients since many of the drugs most vulnerable to shortages – older, generic sterile injectables – are used to treat blood disorders.
ASH applauds FDA for its actions announced today; the Society is particularly pleased that the strategic plan includes both drugs and biologics and the early notification requirements in the proposed rule were extended to manufacturers of medically important biologic products. These biologic drugs, which range from chemotherapeutic agents used to treat patients with blood cancers to plasma protein therapy products and their recombinant analogs used for the treatment of hemophilia and other bleeding disorders, are critical to the delivery of care for patients with blood disorders.
Over the past two years, ASH has been a leading advocate on the topic of drug shortages and has worked closely with FDA in its efforts to combat this crisis. Most recently the Society submitted comments on the agency’s draft drug shortages strategic plan and met with FDA leaders to discuss the importance of including biologics in the strategic plans and the early notification requirements outlined in the proposed rule released today.
ASH continues to monitor all hematologic drug shortages closely on the Society’s Drug Shortage Information page (www.hematology.org/DrugShortages) and will continue to work with FDA and policy makers to protect Americans’ access to lifesaving drugs.
Reporters who wish to arrange an interview with Dr. Abkowitz about ASH's position should contact Amanda Szabo at 202-552-4914 or firstname.lastname@example.org.
The American Society of Hematology is the world’s largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems by promoting research, clinical care, education, training, and advocacy in hematology. The official journal of ASH is Blood, the most cited peer-reviewed publication in the field, which is available weekly in print and online.