Updated Guidelines Allow Men Who Have Sex With Men to Join National Blood Donor Month Efforts

Amid the 55^th annual National Blood Donor Month, new eligibility criteria now allow more people, including men who have sex with men (MSM), to donate blood and help combat shortages.

The Battle Against Blood Shortages

Someone in the US, including accident victims, people in need of transplants, and those being treated for cancer or sickle cell disease, requires blood and/or platelets every 2 seconds.¹ Therefore, blood transfusions use nearly 16 million blood components annually. American Red Cross, which supplies about 40% of blood in the US, estimated that 6500 units of plasma, 5000 units of platelets, and 29,000 units of red blood cells must be collected daily to match patients’ needs.

Since 1970, National Blood Donor Month has been celebrated each January to honor and celebrate the generosity of America’s volunteer blood donors.² It also helps raise awareness around the need for more blood donors as the American Red Cross announced an emergency blood shortage this past summer³; the national blood supply fell by more than 25% amid dangerous heat levels nationwide.

Blood shortages can also occur during the winter as the weather can lead to widespread blood drive cancellations.⁴ Last winter, snow and ice caused about 16,000 blood and platelet donations to go uncollected. Also, the hazardous weather conditions can impact the transportation of vital blood products across the Red Cross network, potentially impacting deliveries to hospitals in affected locations. Additionally, the overlapping cold and flu season may cause people to cancel their appointments since they cannot donate blood while infected with these respective illnesses.

Consequently, the American Red Cross partnered with the National Football League (NFL) for the sixth year to increase donations and combat these seasonal factors.⁵ They encouraged Americans to “step off the sidelines and roll up a sleeve to help patients in need,” awarding those who rise to the challenge between January 1 and 26 by automatically entering them in a raffle for a Super Bowl LIX giveaway. The winners receive round-trip airfare to New Orleans, Louisiana, hotel accommodations, a $1000 gift card for expenses, access to day-of in-stadium activities, and tickets to the official Super Bowl experience.

Evolution of Blood Donor Eligibility Guidelines

This is the second National Blood Donor Month in which MSM can donate blood.⁶ Four decades ago, in 1985, the FDA instituted a lifetime ban on MSM donating blood after researchers discovered that blood transfusions could spread HIV from donor to recipient; HIV was especially prevalent among this population.

The ban remained despite data released in 1988 showing that the prevalence of HIV infection in male blood donors who reported being MSM was 0.25%, which was much lower than the estimated 11% to 12%.⁷ After 30 years, in December 2015, the agency revised its guidelines, reducing the restriction to 1 year. Therefore, MSM had to abstain from doing so for 1 year if they wished to donate blood.

The restriction was again relaxed 5 years later in April 2020 after the COVID-19 pandemic resulted in 86,000 fewer blood donations nationwide in March 2020; instead of 1 year, MSM only had to wait 3 months to donate blood. The FDA maintained this policy within its finalized recommendations released in May 2023. These guidelines focus on individual risk factors instead of group-wide restrictions when assessing blood donor eligibility. They require the same set of risk-based screening questions to be used for all potential donors, regardless of gender, sex, or sexual orientation, to reduce the risk of transfusion-transmitted HIV.

“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.⁸ “The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQ+ [lesbian, gay, bisexual, transgender, questioning plus] community.”

The screening questions ask whether, in the past 3 months, the potential donors had a new sexual partner and engaged in anal sex; had more than one sexual partner and engaged in anal sex; had sex with someone who previously tested positive for HIV infection; and/or taken medicines to prevent HIV infection, like pre-exposure prophylaxis (PrEP).⁹

Other questions include whether, in the last 3 months, the potential donors had sex with someone who exchanged sex for pay or drugs; had sex with someone who used nonprescription injection drugs; and/or exchanged sex for pay or drugs or used nonprescription injection drugs themselves.

Answering no to all screening questions suggests that the potential donor has a low risk of having a recently acquired HIV infection, meaning no waiting period is necessary for them to donate blood. Conversely, answering yes to any screening questions raises concerns that the potential donor may have an HIV infection; a 3-month delay before giving blood would be advised.

A waiting period is also recommended for those who take PrEP as it may cause an HIV test to be negative even if infection is present. Therefore, the new guidelines recommend delaying blood donation for 3 months after the last use of PrEP pills or 2 years after someone receives a long-acting, injected PrEP. Conversely, anyone with a confirmed positive test for HIV infection or who has taken medicines to treat HIV infection remains permanently banned from donating blood.

Jon Oliveira, director of communications and membership for Garden State Equality, a New Jersey-based LGBTQ advocacy and education organization, expressed his mixed feelings surrounding the FDA's relaxed restrictions in an email to The American Journal of Managed Care^®.⁷

“The FDA’s decision to ease restrictions on blood donations from MSM proves what medical experts have been saying for decades: that this ban is not based in science but rather discriminatory politics,” Oliveira wrote.

References

1. Munz K. 5 things to know about donating blood. AJMC. January 10, 2025. Accessed January 10, 2025. https://www.ajmc.com/view/5-things-to-know-about-donating-blood
2. National Blood Donor Month 2025. Accessed January 10, 2025. https://www.blooddonormonth.org/
3. Emergency blood shortage: Red Cross supply drops 25%. News release. American Red Cross; August 5, 2024. Accessed January 10, 2025. https://www.redcrossblood.org/local-homepage/news/article/emergency-blood-shortage.html
4. The Red Cross and NFL want to send you to Super Bowl LIX. News Release. American Red Cross; January 6, 2025. Accessed January 10, 2025. https://www.redcross.org/about-us/news-and-events/press-release/2025/the-red-cross-and-nfl-want-to-send-you-to-super-bowl-lix.html
5. Your Super Bowl experience in New Orleans Awaits. News release. American Red Cross. Accessed January 10, 2025. https://www.redcrossblood.org/local-homepage/events/super_bowl.html
6. AJMC staff. What we’re reading: blood donation guidelines updated; Pfizer CEO criticizes drug price negotiations; drug shortages worsened. AJMC. May 12, 2023. Accessed January 10, 2025. https://www.ajmc.com/view/what-we-re-reading-blood-donation-guidelines-updated-pfizer-ceo-criticizes-drug-price-negotiations-drug-shortages-worsened
7. Shaw M. FDA’s revised blood donation guidance for gay men still courts controversy. AJMC. April 4, 2020. Accessed January 10, 2025. https://www.ajmc.com/view/fdas-revised-blood-donation-guidance-for-gay-men-still-courts-controversy
8. FDA finalizes move to recommend individual risk assessment to determine eligibility for blood donations. News release. FDA; May 11, 2023. Accessed January 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-finalizes-move-recommend-individual-risk-assessment-determine-eligibility-blood-donations
9. Shmerling RH. The FDA relaxes restrictions on blood donation. Harvard Health Publishing. August 8, 2023. Accessed January 10, 2025. https://www.health.harvard.edu/blog/the-fda-relaxes-restrictions-on-blood-donation-202305192936