The Food and Drug Administration (FDA) recently released new
draft guidance that will provide far-reaching updates to blood donor eligibility, proposing significant changes for blood donations for men who have sex with men (MSM). ASCP has been advocating for such a change for some time and will be supporting the overall policy during the 60-day formal comment period.
Restrictions on blood donation from MSM began in response to the AIDS epidemic and continued until this recent update. Specifically, in 1985, the FDA enacted a lifetime ban on blood donations from MSM. In 2015, the agency dropped this ban in favor of requiring MSM to abstain from sex with other men for 1 year prior to donating blood. In 2020, the deferral period was shortened to 3 months. But LGBTQ rights groups and some medical societies, including ASCP and the
American Medical Association (AMA), found these requirements to still be discriminatory in nature. ASCP is therefore excited about the opportunity to comment on the proposed guidance.
The draft guidance was developed after careful FDA review of available information, including the recent successful experience of using individual risk assessment in Canada and other countries with similar HIV epidemiology. The FDA believes these guideline revisions will expand the blood donor pool while maintaining patient safety. ASCP and the transfusion medicine community laud this as an important step toward addressing equity and the US blood supply crisis.
Several important aspects of the draft guidance include:
• Time-based deferrals for MSM and women who have sex with MSM would be eliminated
• The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months
• Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently
ASCP applauds the FDA for releasing these important updates to blood donation criteria. We will continue to monitor and report on this important policy change that makes blood donation available to a new population segment that was previously denied.
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