FDA Initiating National Blood Surveillance Monitoring System
New York, NY – 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(FDA) for initiating development of a national blood surveillance monitoring system coinciding with the release of the Draft Guidance for Industry concerning blood donor deferral policies for men who have sex with men (MSM).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,” said Val D. Bias, Chief Executive Officer of the National Hemophilia Foundation (NHF).
At today’s Blood Products Advisory Committee meeting, FDA released more information regarding its plans for implementing the Transfusion Transmissible Infections Monitoring System (TTIMS), the national blood surveillance system that 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,” stated 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 and fully supports the adoption of donor deferral policies that are less discriminatory, as long as the overall risk to end users is not increased.
The National Hemophilia Foundation (NHF) is dedicated to finding better treatments and cures for inheritable bleeding disorders and to preventing the complications of these disorders through education, advocacy and research. Established in 1948, the National Hemophilia Foundation has chapters throughout the country.