American Society of Hematology

2013 ASH Advocacy Efforts to Ensure Access to Safe and Effective Hematologic Drugs

Published on: January 30, 2014

  • Drug Shortages
    Over the past three years, shortages of drugs and biologics used to treat patients with hematologic diseases, including leukemia and lymphoma, became critical and life-threatening.  ASH has taken a number of steps to resolve these drug and biologic shortages, including working with manufacturers, the Food & Drug Administration (FDA) and Congress.  ASH continues to be actively involved in this issues and the following is a summary of recent ASH advocacy efforts to address drug and biologic shortages.

    • 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.

    • Work with Congress – ASH continues to work with Congress on drug shortages.  The Society will also review and analyze new legislation that is introduced to address the economic aspects of drug shortages. 

    • Communication with Manufacturers ASH continues to contact drug companies to obtain information about the drugs in short supply, specifically what is causing the delays and when the drugs will become available. Information about hematologic drug shortages is posted to the ASH Drug Shortage Information page.
     
  • Oral Chemotherapy Parity
    While oral and patient-administered forms of chemotherapy have become more prevalent and represent the standard of care for many types of cancers for their convenience, efficacy, and low rate of side effects, they are covered differently than IV drugs, leaving many patients responsible for unsustainably high monthly co-payments.
    • Federal Legislation – As part of the Patient Equal Access Coalition (PEAC), ASH has advocated for legislation in the U.S. House of Representatives (H.R. 1801, the Cancer Drug Coverage Parity Act) and the U.S. Senate (S. 1879, the Cancer Treatment Parity Act) to ensure that cancer patients have equality of access (and equality of insurance coverage) to all approved anticancer regimens including, but not limited to oral and intravenous drugs.
    • State Legislation – ASH has also supported similar legislative efforts at the state level (in Michigan) and will continue to work with stakeholders and advocacy groups to support ongoing legislative efforts in a number of additional states.
     

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