American Society of Hematology

House and Senate Pass FDA Bills on User Fee Programs & Drug Shortages; Vote on Final Legislation Expected Near July 4

Published on: May 31, 2012

On May 30, the U.S. House of Representative passed H.R. 5651, its version of the Prescription Drug User Fee Act (PDUFA) legislation including important provisions to mitigate drug shortages, most notably mandating an early warning system for manufacturers. The U.S. Senate passed S. 3187, its version of PDUFA on May 24, which includes similar provisions to combat drug shortages. In addition to addressing drug shortages, the House and Senate bills both would create user fee programs for generic drugs and generic biologic drugs, or biosimilars, and include provisions that focus on the safety of the drug supply chain and other issues.

The House and Senate are now expected to begin the conference committee process to reconcile differences in their respective legislation and set up quick votes in both chambers for final passage. House and Senate leaders have set a goal of delivering a final bill to President Obama by July Fourth.

While ASH believes the bills help address drug shortages, the Society is concerned that the Senate bill exempts biologics from all provisions and both bills specifically exempt 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 is finalized, ASH will continue to work with Congressional leaders to ensure that biologics, human plasma protein derivatives and recombinant products are included.

Over the past 18 months, ASH has worked closely with Congressional leaders throughout the development of the drug shortage legislation. ASH has made several recommendations on ways to prevent and mitigate shortages, including to: increase FDA authority, require that the Secretary disseminate information about drug shortages to patient and provider organizations, enhance inter and intra agency coordination on drug shortages, require that the Agency Strategic Plan consider the impact of drug shortages on research and clinical trials, examine the impact of current FDA requirements on shortages, and provide economic incentives to manufacturers of critical drugs. The Society's advocacy has been successful and the current House and Senate bills include several of ASH's key recommendations. The following ASH recommendations were incorporated in the Senate bill:

  • Including sterile injectable products within the definition;
  • Requiring that the Secretary to disseminate information about drug shortages to patient and provider organizations;
  • Requiring enhanced inter and intra agency coordination and requiring increased and effective communication with outside stakeholders; and
  • Requiring that the Strategic Plan consider the impact of drug shortages on research and clinical trials.

ASH will continue to monitor all hematologic drug shortages closely and will continue to work with policy makers to further strengthen the PDUFA legislation. More information about drug shortages and ASH advocacy is available on the ASH website.

Read the ASH press releases on the House Passage of PDUFA and the Senate Passage of PDUFA.

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