FDA Finalizes Blood Donation Guidelines, Expands Eligibility

After months of deliberation and review, the FDA has finally expanded its blood donor eligibility by adjusting its donation guidelines. Joining other developed nations, including the United Kingdom and Canada, the United States will now approach blood donor eligibility using individual risk assessments.

Before these rulings, blood donation guidelines restricted specific individuals from donating blood based on gender identity and sexuality. Despite the previous policy modification that allowed gay and bisexual men to donate if abstinent for one year, these community members still faced difficulties when donating blood.

On January 27, 2023, the FDA issued an initial draft recommendation for updated blood donation guidelines. After carefully reviewing the guidance and commentary submitted on the draft recommendation, the FDA finalized protocols on May 11, 2023.

“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA press release.

Under the new guidance, anyone who goes to donate blood will answer a series of questions to assess individual risk and classify their eligibility to donate blood. Anyone — regardless of gender identity or sexuality — who reports a new sexual partner, more than one sexual partner, or having anal sex in the past three months will be deferred from donation.

Additionally, anyone taking medications to treat or prevent HIV is not eligible to donate blood. The FDA acknowledges that these drugs are safe and effective; however, out of caution, they are restricting blood donation as they may delay or alter the detection of HIV.

“The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations, and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place,” added Marks.