Red Cross Adopts FDA’s Blood Donation Policies to Expand Eligibility

On August 7, 2023, the American National Red Cross announced that it would adopt the United States Food and Drug Administration’s new blood donation protocols. This shift will widen donor eligibility, lifting restrictions on LGBTQ donors.

After deliberation, the FDA released its finalized recommendations for blood donor eligibility on May 11, 2023. The updated screening guidelines were issued as a draft recommendation on January 27, 2023. Unlike other countries, the US blood donation system restricted donations from patients based on gender identity and sexuality.

Although the rhetoric around these restrictions implied they were vital for securing a safe blood supply, research and guidelines from other countries have refuted the claim.

In its statement, the red cross notes, “For years, the Red Cross has worked to change the deferral policy concerning men who have sex with men – this work included decades of data collection and assessment to improve transfusion safety, ongoing advocacy to eliminate donor questions based on sexual orientation, and our recent role as a leading contributor in the FDA-funded ADVANCE Study.”

ADVANCE stands for assessing donor variability and new concepts in eligibility. The ADVANCE study was a collaborative effort by Vitalant, OneBlood, and the American Red Cross, funded by the FDA, to assess donor eligibility for men who have sex with men (MSM).

The study results were published as a preprint on April 9, 2023. In the publication, the researchers conclude, “Among sexually active MSM, there are subgroups who self-report no new sexual partners and only one sexual partner within the past three months. These individuals are likely at lower risk of HIV infection than other MSM and would meet proposed individual risk assessment criteria for blood donation in the US.”

The FDA implemented new protocols based on this data and other historical research. While the blood donor guidelines for LGBTQ patients have eased through the decades — going from completely prohibiting donation to strict abstinence-based restrictions, these new protocols will evaluate all donors equally regardless of identity.

The finalized recommendations by the FDA implement a series of questions to assess individual risk for any potential donor, determining eligibility based on the results. The survey can exclude any patients who report a new sexual partner, more than one sexual partner, or anal sex in the three months before donation.

Despite a consensus that HIV prevention drugs are safe and effective, the survey will also be used to exclude patients taking HIV medication as a precaution.

As the Red Cross and other blood donation organizations adopt these new guidelines, they open the door to more eligible donors, a larger blood supply, and, inevitably, more patients saved.