The US Food and Drug Administration (FDA) announced on Thursday (May 12) that it has legally lifted the long-standing ban on gay and bisexual males donating blood. The organization also stated that it is nearing completion of a suggestion that includes a questionnaire to screen donors based on their recent sexual activity rather than their sexual orientation or gender.
The change is consistent with the FDA’s recent relaxation of its blanket restriction on gay and bisexual males donating blood. The prohibition was first enacted during the 1980s HIV/AIDS epidemic and has long been criticized as discriminatory by the LGBTQI+ community and its allies.
“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, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
According to the most recent FDA standards, gay and bisexual males in a monogamous relationship with a man are not need to abstain from sex before giving blood. Previously, they were required to have a three-month deferral period during which they did not have sex with another man.
Since the onset of the global HIV/AIDS epidemic, the FDA has imposed a lifetime restriction on blood donations from gay and bisexual males in the United States, stating that the measure has helped to keep HIV out of the blood supply. It finally repealed the rule in 2015, but stipulated that men who have sex with men (MSM) must abstain from intercourse for a year before giving blood. In 2020, the time limit was reduced to three months.
Although the new criteria have eliminated the deferral period for monogamous MSM, it remains in effect for those who have had new or many partners, as well as anal sex, in the previous three months.
“All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing.,” said the FDA in a statement.
Aside from that, the new rules state that all potential donors, regardless of sexual orientation, gender, or sex, will be evaluated with a new questionnaire that assesses their unique risks for HIV based on sexual behavior, recent partners, and other criteria.
Meanwhile, the agency hasn’t changed its policy around those who have tested positive for HIV as they will remain ineligible to donate blood. “Those taking pills to prevent HIV through sexual contact will also still be barred, until three months after their last dose. The FDA noted that the medications, known as PrEP, can delay the detection of the virus in screening tests.,” PBS reported.
The FDA has stated that the latest revisions to its blood donation regulation are a recommendation to the industry. Because blood banks are not required to follow them, the guidelines may vary significantly from location to location, according to CNN.
Blood banks, medical groups, and LGBTQI+ advocacy organizations have mainly expressed support.
In a statement, Sarah Kate Ellis, President and CEO of GLAAD, the Gay and Lesbian Alliance Against Defamation, said the new proposals mark “the beginning of the end of a dark and discriminatory past rooted in fear and homophobia.” However, Ellis, like many others, believes that the revised guidance does not go far enough because it still forbids LGBTQI+ persons on PrEP from donating blood, according to CNN.
“Placing potential blood donors taking PrEP in a separate line from every other donor adds unnecessary stigma. The bias embedded into this policy may, in fact, cost lives. GLAAD urges the FDA to continue to prioritise science over stigma and treat all donors and all blood equally,” Ellis added.
The new criteria were implemented not only to address the discriminatory character of the current policy, but also to increase blood donations across the United States. According to media accounts, the amount of blood donations in the country fell during and after the coronavirus epidemic, as school and office-based blood drives declined.
When the FDA first announced the policy changes in January of this year, Marks stated, “Maintaining a safe and adequate supply of blood and blood products in the US is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”