On July 22nd, the US Department of Health and Human Services (HHS) provided an update on its plans to implement the June 2010 Advisory Committee on Blood Safety and Availability (ACBSA) recommendations related to the current ban on blood donation from men who have ever had sex with a man (MSM). During the June 2010 meeting, the committee acknowledged that current deferral polices are suboptimal in permitting some potentially high-risk donations, while preventing some potentially low-risk donations. It then unanimously agreed to a series of recommendations on needed research. For more information on that meeting, click here.
Following the June 2010 ACBSA meeting, Dr. Howard K. Koh, HHS Assistant Secretary for Health, charged the Blood, Organ, and Tissue Safety Working Group with developing a plan of action based on the recommendations. The working group is composed of representatives from multiple agencies in HHS, including the FDA, CDC and HRSA, as well as the Centers for Medicare and Medicaid Services (CMS).
The working group has identified the following research questions as being critical to evaluating whether the MSM blood donation ban can be revised:
a. How does the risk of blood transmissible diseases in the current donor population relate to risk factors in donors?
b. What is the root cause of Quarantine Release Errors, the accidental release of blood not cleared for use, that occur at blood collection centers and potentially put the blood supply at risk, and what mitigations can be considered?
c. Donor evaluation:
1. Do potential blood donors correctly understand and properly interpret the current standard questionnaire used to obtain donor history?
2. What motivates a man with MSM behavioral history to donate and would MSM be likely to comply with modified deferral criteria?
d. Would alternative screening strategy (e.g., pre- and/or post-qualifying donation infectious disease testing) for MSM (and potentially other high-risk donors) assure blood safety while enabling collection of data that could demonstrate safe blood collection from a subset of MSM or other currently deferred donors (e.g., men with a history of abstinence from MSM behavior for a defined time period)?
HHS has laid out the steps required and timeline to complete this research. It anticipates that the first three studies could be completed in the next 18 to 24 months, and has scheduled an FDA conference on Quarantine Release Errors in September to provide guidance on question (b). The final study (d) could be completed in 24 to 36 months. The policy would then be reviewed in light of this new data.
NHF will continue to monitor HHS activities related to this issue and will remain vigilant to ensure the safety of the blood supply.
