American Society of Hematology

President Obama Signs FDA Bill on User Fee Programs & Drug Shortages; ASH Advocacy Successful

Published on: July 10, 2012

On July 9, President Barack Obama signed The Food and Drug Administration Safety and Innovation Act into law (Public Law No: 112-144). The final legislation, also known as the Prescription Drug User Fee Act (PDUFA), includes provisions to mitigate drug shortages, which ASH advocated. In addition to addressing drug shortages, the new law creates user fee programs for generic drugs and generic biologic drugs, or biosimilars, and includes provisions that focus on the safety of the drug supply chain, among other issues. ASH's comprehensive summary of the drug shortage provisions in the bill can be found on the Society's Website.

Most recently, ASH successfully worked to remove language added to a later form of 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 in House and Senate, 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.

The Society thanks all of the ASH Members whose participation in the Society's drug shortage advocacy campaigns was key to this successful outcome.

ASH will continue to monitor all hematologic drug shortages closely. Information about specific drug shortages is available on the ASH Drug Shortage Update page.

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