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Blood and Blood Product Safety

Blood and Blood Product Safety

The national tragedy of HIV/AIDS in the hemophilia community catapulted NHF into the spotlight as the prime advocate for a safer blood supply and blood products. While blood and blood product safety have dramatically improved over the last 20 years, the risk remains for known and unknown potential infectious agents and pathogens that threaten the blood supply and blood products. Throughout its work on blood safety, NHF's stance has never wavered.

Today, NHF's commitment to blood product safety drives a strong nationwide research effort into improved treatments, including improved protein-free recombinant clotting factor products and gene therapy. Blood safety must and will always be a top NHF priority.

Current Activities

  • Federal Advisory Committees – NHF continuously monitors the activities of several federal advisory committees, including the Department of Health and Human Services Advisory Committee on Tissue and Blood Safety and Availability, and the FDA's Blood Products Advisory Committee and Transmissible Spongiform Encephalopathies Advisory Committee.
  • MSM Donation Policies – Working with other members of the American Plasma Users Coalition (APLUS), NHF has been actively engaged in the recent debate around whether men who have had sex with another man (MSM) should be permitted to donate blood.  We have written several comment letters and testified before Committees on this issue and will continue to advocate for donor deferral criteria based on scientific and epidemiological evidence.
  • Patient-focused Drug Development – NHF successfully advocated for hemophilia and other inherited bleeding disorders to be included on the list of conditions for which there will be Patient-Focused Drug Development meetings, as required by the Food and Drug Administration Safety and Administration Act (FDASIA).  There will be a meeting focused on bleeding disorders in FY 2014 or 2015.
  • Biosimilars – NHF advocated for the creation of a regulatory pathway for the approval of biosimilars in the Affordable Care Act, provided it included important patient protections surrounding interchangeability and clinical trials.