On December 21, 2015, the Food and Drug Administration (FDA) finalized its revision of blood donor deferral policies for men who have sex with men (MSM). In addition, FDA continued implementation of a national blood surveillance monitoring system, and changed its deferral policies for people with hemophilia and their sexual partners. FDA’s final guidance on donor deferral policies reflects a number of priorities advocated for by NHF and APLUS, the coalition of patient advocacy organizations representing those who use blood, plasma-derived and recombinant products.
Beyond changing the MSM lifetime donor deferral to a one-year deferral, the FDA’s guidance includes changes to deferral policies for people with hemophilia and their partners. People with hemophilia (PWH) are no longer deferred because of a risk of transmitting HIV; therefore, their sexual partners will no longer be deferred for this reason. Under prior donor policies, partners of PWH were deferred for a year. However, PWH will be deferred due to the risk of being injured by the large needles used during the donation process.
Yesterday’s FDA announcement also discusses the implementation of a national blood surveillance system that will help the agency monitor the effect of this policy change and further help to ensure the continued safety of the blood supply. This monitoring system is a joint project of the FDA and the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH). The creation of the blood surveillance system has been a top priority of NHF and APLUS.
NHF has advocated that the complex blood safety policies, such as those related to donor deferral, should be based on science. NHF has recognized that the prior lifetime MSM deferral policy was suboptimal. It supports the adoption of donor deferral policies that are less discriminatory, as long as the overall risk to end users is not increased.
NHF will work with the FDA, stakeholders in the blood and plasma collection communities, and its colleagues in APLUS as these new donor deferral policies are implemented and the blood surveillance monitoring system continues over the coming months and years.
The FDA’s statement on these changes can be found here.