Statement from American Society of Hematology (ASH) President Armand Keating, MD, on FDA Action to Alleviate Drug Shortages
WASHINGTON, Feb. 21, 2012 /PRNewswire-USNewswire/ -- ASH is encouraged by the steps FDA is taking to alleviate drug shortages that have significantly affected so many patients with hematololgic malignancies under our members' care. The measures announced today are consistent with the Society's recommendations to FDA, Congress, and the Obama Administration to expand the agency's authority to prevent drug shortages by requiring manufacturers to provide early notification of impending shortages and importing drugs in critical supply.
While ASH applauds the specific actions announced today, we also realize that these measures represent only a portion of a solution to a much larger problem. In addition to these steps, additional measures - such as developing a national drug registry and providing economic incentives to manufacturers to produce a steady supply of generics - must be implemented to permanently prevent shortages. Until a complete solution is in place, treatment will be delayed and care will be rationed for critically ill patients. ASH will continue to support legislative, regulatory, and policy changes that will give FDA the ability to prevent and mitigate drug shortages before they progress to crisis status.
The American Society of Hematology (www.hematology.org) 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 (www.bloodjournal.org), the most cited peer-reviewed publication in the field, which is available weekly in print and online.