Work with the Food and Drug Administration (FDA) – ASH continues to alert FDA about new hematology/oncology drug shortages. ASH also provides the Society’s members with real-time updates from the FDA about hematologic drug shortages through ASH’s e-publications and Drug Shortage Information page.
Over the past year, ASH submitted comments to the FDA on its draft strategic plan and recently submitted feedback to the Agency on its proposed advanced notification requirements for drug and biologic shortages. ASH has also met with FDA leaders to discuss the importance of including biological products under the advanced notification requirements authorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. ASH’s advocacy was instrumental to ensuring the inclusion of biologics in two guidance documents the FDA released on October 31, 2013: (1) the Agency’s strategic plan to enhance its response to preventing and mitigating shortages of drugs and biologics; and (2) a proposed rule requiring all manufacturers of certain medically important prescription drugs and biological products to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply.