FDA proposes allowing gay and bisexual monogamous men to donate blood

The U.S. Food and Drug Administration announced Friday it will ease blood donation restrictions on gay and bisexual men, including allowing those in monogamous relationships to donate.

The policy change, which was revealed in new draft guidance, comes after years of urging by public health experts, blood banks and LGBTQ advocacy groups. The new policy would address future blood shortages and remove the stigma around gay men, experts say.

Additionally, the American Red Cross and the American Medical Association have both supported a risk-based approach to donor eligibility.

"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," FDA Commissioner Dr. Robert M. Califf said in a statement. "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."

Rather than a blanket ban due to sexual orientation, the relaxation of the rule would screen potential donors on their risk of contracting and transmitting HIV.

The FDA said it will use "gender-inclusive, individual risk-based questions" without compromising "the safety or availability of the blood supply."

Questionnaires will ask all donors about new or multiple sexual partners in the past three months. Those who have had a new sexual partner or multiple partners in the past three months will be asked about their history of anal sex during that time period.

For the first time, the proposal will also affect women who engage in intercourse with men who have sex with men.

"Our approach to this work has always been, and will continue to be, based on the best available science and data," Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. "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."

The proposal will be open to public comment for 60 days, after which the FDA will review comments before finalizing the draft guidance. During a press conference this morning, Marks said the guidance will be finalized in a matter of weeks after the public session closes. Califf added that because officials don’t know what the comments will be, there is no timeline for how quickly the guidance will be finalized.

When asked why this policy has no effect on individuals who have had vaginal sex, Marks explained there is a risk of exchanging blood that is higher from anal intercourse compared to vaginal intercourse.

In the 1980s, in response to the HIV/AIDS crisis, the FDA banned all blood donations from men who have sex with men.

The policy did not change until 2015, when rules were slightly relaxed to allow this group of donors to give blood as long as they abstained from sex for one year. In 2020, amid severe blood shortages during the start of the COVID-19 pandemic, the FDA shortened the abstinence period to 90 days.

The policy change means gay and bisexual men in monogamous relationships can donate without abstaining from sex as long as they test HIV negative and are practicing safe sex.

It also means the U.S. will join several Western countries, including the United Kingdom, France, Greece and the Netherlands, which have recently either dropped bans or eased restrictions.

'These changes are 40-plus years in the making, and are a tremendous leap forward toward elevating science over stigma," Sarah Kate Ellis, president and CEO of GLAAD, said in a statement. "GLAAD and leading medical experts have long been advocating for guidelines that see and treat LGBTQ people the same as any other person, including as potential donors who want to help others."

"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."

Last month, the FDA told ABC News the evidence analyzed so far will "likely support a policy transition" that focuses screening blood donations based on each person’s HIV risk.

In 2020, the FDA launched a study called ADVANCE to look into alternative solutions to its current policy. The FDA told ABC News back in December it was reviewing research from the American Red Cross, OneBlood and Vitalant to determine if eligibility based on an individual's risk can replace the current time-based deferral system while maintaining the safety of the blood supply.

Experts say the updated policy will also help address the national blood shortage and, in turn, save lives. In January 2022, the American Red Cross said it was facing its worst blood shortage in more than a decade, although it is no longer in a crisis.

Despite the easing of rules, non-monogamous men are not allowed to donate even if they produce a negative HIV test, practice safe sex with condoms or take pre-exposure prophylaxis, or PrEP -- a daily pill containing two medications that prevent HIV-negative patients from being infected.

During the press conference, Marks said deferrals for those taking PrEP are because taking these medications delay the detection of HIV and may result in blood samples with false-negative results. However, Marks and Califf recommended those at risk do not stop taking these medications so they can donate blood.

ABC News’ Sony Salzman and Kiara Alfonseca contributed to this report.