FDA Will Relax Blood Donor Restrictions on Gay, Bisexual Men

The Food and Drug Administration announced on Friday that is proposing changing its blood donation guidelines for men who have sex with men (MSM) and women who have sex with MSM to focus not on gender or sexual orientation, but on sexual behaviors.

The agency said that the change would be in line with similar policies in Canada and the U.K.

While the most recent rules allowed queer men to donate blood if they hadn’t had sex with another man in the previous three months, the new rules would allow MSM to donate blood if they hadn’t engaged in certain sex acts in the last few months.

In its announcement, the FDA said that the draft recommendations eliminating the time-based deferrals come from a review of data from other countries implementing similar approaches as well as an understanding of the U.S. blood supply. It said the proposed changes wouldn’t harm the current blood supply.

“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Dr. Robert M. Califf. “Maintaining a safe and adequate supply of blood and blood products in the U.S. 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.”

Besides the removal of time-based referrals to blood donation questionnaires, there will also be the removal of gender-specific language. Now, all prospective donors will be asked about new or multiple sexual partners in the last three months. If they did have new or multiple partners, a prospective donor will be asked about having had anal sex in the past three months. Those who had would be prevented from donating.

A potential donor will be eligible to donate if they haven’t had new or multiple sexual partners, had anal sex, and if they meet other previous criteria.

Those who take PrEP or PEP would be deferred for three months from their most recent dose, the FDA said. Those taking injectable PrEP or PEP would have to defer for two years since their last dose. The agency said this was due to “available data” that indicates that PrEP and PEP could interrupt HIV detection in some screening tests for blood donations.

The FDA urged those on PrEP to continue taking the medication and should not stop taking it in order to donate blood.

“Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said. “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”

The FDA will now open the proposal to public comment for the next 60 days.

The policy's history on queer men goes back to the beginning of the HIV epidemic in the 1980s. In 1985, the FDA put a lifetime donation ban on men who have sex with men. However, in 2015, that was changed to a requirement for 12 months of celibacy before donation, due to advances in HIV testing and treatment. In 2020, the policy was changed again to the current three months of celibacy due to blood shortages early in the COVID-19 pandemic.

The continued limits on gay and bi blood donation are seen as homophobic and stigmatizing by many. Under the current rules, a man who had sex with one man over the past 90 days is banned from donation, while a man with numerous female sex partners is allowed to donate.

Lesbian and bisexual women don't have a deferral period under current guidelines.

The Biden administration indicated in January 2022 that they were open to amending the current policy banning men from donating blood if they've had sex with another man in the past three months.“I commend FDA for proposing a shift to a gender-inclusive, individual risk-based assessment for blood donations,” Assist Secretary for Health Dr. Rachel Levine said in a statement. “This positive change treats everyone the same regardless of gender and sexual orientation. Once finalized, this policy will help ensure a steady and safe supply of blood to save lives by asking everyone the same risk-based questions.”

LGBTQ+ rights groups praised the new draft guidelines.

"The announcement today will ease historic discrimination against LGBTQ Americans, help alleviate the national blood shortage, and opens the door for all eligible LGBTQ people to give blood and save lives," said Sarah Kate Ellis, president and CO of GLAAD, in a statement. "The U.S. moves closer to joining the growing list of countries that already welcome blood donations from gay and bi men without restrictions. LGBTQ leaders will continue to advocate until the FDA enacts those science-based, safe, and stigma-free guidelines.”

The Human Rights Campaign said that the proposed changes still need some work, though the organization still lauded the changes as positive steps forward.

"This new policy removes a decades-long barrier for many in our community – and there is more to do to ensure gay, bisexual, and transgender people are no longer unfairly stigmatized when they try to donate blood. The assessment criteria have flaws, focusing excessively, for instance, on the number of partners a potential donor has instead of just on new partners," Kelley Robinson, HRC's president said in a release. She added that it was "unfortunate that the new policy continues to ban those on PrEP from donating blood. PrEP is the most powerful weapon we have to protect individuals from contracting HIV and to eventually wipe out the disease entirely. The fact that being on PrEP can conceal HIV positivity is accurate, but there is a solution on the horizon thanks to technologies being developed that would inactivate pathogens in the blood."