During 2012, shortages of drugs used to treat patients with hematologic diseases, including leukemia and lymphoma, became critical and life-threatening. ASH has taken several steps to resolve these drug shortages, including working with manufacturers, the Food & Drug Administration and Congress. The following is a summary of ASH advocacy efforts to address drug shortages. A current list of hematologic drugs in shortage is available on the ASH website.
ASH Response to Drug Shortages
- Communication with Manufacturers – ASH contacted 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 website as it becomes available.
- Work with the Food and Drug Administration (FDA) – ASH alerted the FDA to the hematology/oncology drug shortages and made several recommendations on how to prevent and mitigate shortages. Many of ASH's suggestions have been implemented, including increasing staff at the Office of Drug Shortages and improving communication to physicians. ASH also met with FDA leaders to discuss the importance and public health benefit of including biological products in the advanced notification requirements of potential drug shortages authorized by the Food and Drug Administration Safety and Innovation Act (FDASIA).
- Work with Congress – ASH was the first medical society to notify congressional committees about the problem and request a hearing on the issue. ASH worked closely with House and Senate sponsors of legislation that would provide the Food and Drug Administration (FDA) with tools to help address and prevent future medication shortages. ASH submitted several comments to Congress on how to address drug shortages and how to strengthen proposed legislation (all comments and testimony are available on the ASH website). On July 9, President Barack Obama signed The Food and Drug Administration Safety and Innovation Act into law (Public Law No: 112-144). ASH's comprehensive summary of the drug shortage provisions in the bill can be found on the Society's Website.
- Grassroots Advocacy – ASH developed an advocacy campaign to encourage congressional support of drug shortage legislation. ASH also created a special patient advocacy campaign that physicians could share with patients. Through these campaigns, ASH was able to influence the final legislation. ASH advocacy resulted in the removal of language added to the House and Senate bills that would have exempted biologics and products derived from human plasma proteins and recombinant products replacing human tissue – products used for the treatment of hemophilia and other bleeding disorders – from the early reporting mandate in the legislation. As the legislation was being finalized, ASH worked with Congressional leaders to ensure that biologics, human plasma protein derivatives and recombinant products would be included. The final legislation also gives the Secretary of the Department of Health and Human Services (HHS) the authority to apply these requirements to biological products.
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