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Senate Passes FDA Bill Addressing Drug Shortages

Jun 21, 2012

The United States Senate has passed S. 3187, the Food and Drug Administration Safety and Innovation Act. While the primary purpose of the bill is to reauthorize and extend various fees relating to brand name and generic drugs, the bill also contains important changes that directly address the critical drug shortages that are affecting EMS agencies across the country.

Under current law, manufacturers of life-saving and life-sustaining drugs must report a discontinuation of production of the drug to the Department of Health and Human Services only if they are the sole source of that particular drug. Under the changes contained in S. 3187, drugs used in emergency services, as well as all sterile injectable drugs, will be added to the list of drugs requiring reporting. In addition, the reporting requirements will apply to all manufacturers of the drugs and will pertain to significant disruptions in production in addition to a complete discontinuation of production.

The bill also would require the FDA to establish a task force to monitor and respond to pending drug shortages, allow expedited review of potential alternatives to drugs facing potential shortages, and require the FDA to work with the Secretary of HHS to improve communication to the healthcare community of potential shortages and appropriate alternatives. These changes were driven by the EMS community.

The House Energy and Commerce Committee reported out of committee a similar bill addressing FDA fees and drug shortages. However, it has yet to be considered or passed by the full House of Representatives. Once the House passes its bill, the House and Senate must work together to agree on a final version of the bill. Given the momentum we have recently seen, fueled in large part by a strong and unified advocacy effort by the EMS community, we are confident that drug shortages will be addressed in the eventual final bill.

This is legislation that NAEMT worked on in collaboration with many other organizations, including AEMS, ACCT, IAFC, NAEMSP, ACEP, NASEMSO, NAEMSE, and NEMSMA.