The National Hemophilia Foundation (NHF) commends the US Food and Drug Administration (FDA) for initiating development of a national blood surveillance monitoring system coinciding with the release of the Draft Guidance for Industry concerning blood donor deferral policies for men who have sex with men (MSM).
“We are pleased that FDA is moving forward on both interrelated elements of the proposed MSM policy change. Together they provide the necessary balance of respecting donors and protecting patients,” says Val D. Bias, chief executive officer of NHF.
At the Blood Products Advisory Committee (BPAC) meeting on May 13, 2015, FDA released more information regarding its plans for implementing the Transfusion Transmissible Infections Monitoring System (TTIMS). The national blood surveillance system will help the agency ensure the continued safety of the blood supply and monitor the effects of this policy change.
“We are pleased to learn further details of FDA’s long-term commitment to a robust, national comprehensive blood surveillance system, which is critical to ensuring the ongoing safety of the blood supply,” states Bias. “We will continue to work with the FDA and other stakeholders as TTIMS is implemented.”
NHF’s position has been that complex blood safety policies should be based on science. NHF has recognized that the existing MSM deferral policy has been suboptimal. It fully supports the adoption of donor deferral policies that are less discriminatory, as long as the overall risk to end users is not increased.