FDA Eases Restrictions on Blood Donations by Men Who Have Sex with Men

FDA updates guidelines after man who recently recovered from COVID-19 was told that he could not donate blood for 12 months because he takes Truvada as a pre-exposure prophylaxis treatment.

Citing a public health emergency related to the coronavirus disease 2019 (COVID-19), the FDA has announced that it has eased its restrictions on blood donations from men who have sex with men (MSM).1

The new guidelines reduce the donation deferral period for sexually active gay and bisexual men from 12 months to 3. This reduction still means that healthy MSM will need to abstain from same-sex sexual activity for 90 days in order to be eligible to donate blood.1

Although the guidelines are not seen as “enforcement” on the part of the FDA, they do reflect the agency’s current thinking on the topic and should be viewed as recommendations, unless specific regulatory requirements are cited, according to the report.2

The emergence of AIDS in the early 1980s and the recognition that it could be transmitted by blood and blood products had a profound effect on the US blood system. Although initially identified in MSM and associated with male-to-male sexual contact, AIDS was soon noted to be transmitted by the transfusion of blood products.2

The restrictions on MSM blood donors date back to 1983, when the federal government instituted a lifetime ban on blood donations by MSM. The rule was intended to keep HIV out of the blood supply and was replaced in 2015 with a year-long abstinence requirement.1

In a call last week with reporters, Surgeon General Jerome Adams said that it is “critically important” that people living with HIV do not give blood, but said that the new changes better reflected the time it takes to detect HIV in blood after certain behaviors.1

He also mentioned changes to the donor requirements for people who have recently gotten tattoos or piercings, hoping that it would grow the eligible blood donor pool. “These changes are based on the best science that we have today regarding the time that it takes to test positive for HIV,” Adams told reporters, saying that the updated guidance would reduce stigma and encourage more people to donate blood.2

In a previous report by NBC News, an MSM who recently recovered from COVID-19 was told that he could not donate blood for 12 months because he takes Truvada as a pre-exposure prophylaxis treatment.3 These restrictions on blood donations from gay and bisexual men, who represent 70% of all new HIV infections in the United States, have come under scrutiny in recent months from lawmakers and LGBTQ advocates. Organizations such as the Gay and Lesbian Alliance Against Defamation (GLAAD) released a petition to lift the ban entirely.4

Additionally, the American Red Cross had previously filed a statement regarding the FDA guidelines, stating that “blood donation eligibility should not be determined by methods that are based upon sexual orientation.”

According to the American Red Cross statement, the 3-month deferral time is consistent with policy changes made by countries such as Canada and Great Britain.

Adams said it’s “critically important” that people living with HIV do not give blood, but said the new changes better reflected the time it takes to detect HIV in blood after certain risky behaviors. Adams also touted changes to the donor requirements for people who have recently gotten tattoos or piercings, hoping they too would grow the eligible blood donor pool.1

Reference

  • FDA eases restrictions on gay blood donors amid 'urgent need.’ NBC News website. Published April 2, 2020. https://www.nbcnews.com/feature/nbc-out/fda-reduces-restrictions-gay-blood-donors-amid-urgent-need-n1175141. Accessed April 8, 2020.
  • Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. FDA website. Published April 2, 2020. https://www.fda.gov/media/92490/download. Accessed April 8, 2020.
  • Fitzsimons, Tim. Doctors can't use COVID-19 antibodies from gay men or anyone taking PrEP. NBC News website. Published April 1, 2020. https://www.nbcnews.com/feature/nbc-out/doctors-can-t-use-covid-19-antibodies-gay-men-or-n1174341. Accessed April 8, 2020.
  • Lift the Ban on Gay, Bisexual, and MSM from Donating Blood and Plasma. GLAAD website. http://glaad.nationbuilder.com/blood?fbclid=IwAR2ogzsNzms3sL_DwUsJV6sRXWKc9eTbvJigcCt1m9Vcx8-T_rueC1nCxWw. Accessed April 8, 2020.
  • American Red Cross Statement on FDA MSM Deferral Policy [news release]. American Red Cross website. Published November 21, 2019. https://www.redcross.org/about-us/news-and-events/press-release/american-red-cross-statement-on-fda-msm-deferral-policy.html. Accessed April 8, 2020.