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FDA Lifts Blood Donation Ban for Gay & Bisexual Men...But There's a Catch

News & Opinion | Health

The world celebrated Friday, Jan. 27th after the U.S. Food and Drug Administration announced they would lift the decades-long ban and relax restrictions on sexually active gay and bisexual men from donating blood. The proposed new guidelines will no longer require gay and bisexual men to abstain from sex for 3-months before donating blood. The proposal follows in the footsteps of policies put in place in the United Kingdom and Canada.

The draft guidelines will now focus on the sexual behaviors of all people — rather than singling out gender and sexual identities and instead, measure the risk of transmitting HIV based on sexual practices alone. For the first time, the proposal will also affect women who engage in sexual intercourse with men who have sex with men.

Under the new proposed guidance:

  • The time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.

  • The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.

The Catch

Despite easing restrictions for men in monogamous relationships, the FDA will continue to bar men from donating who have had anal sex with new or multiple sex partners within the last 3-months, currently taking PreP, and those not in non-monogamous relationships even if they produce a negative HIV test or use safe sex practices. The FDA is set to review public comments before finalizing the proposal.

Under the new proposed guidance, here are the restrictions:

  • Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months.

  • All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.

Proposed guidance related to pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP):

  • Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose.

  • Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection.

  • Some blood establishments currently have deferral policies related to the use of medications to prevent HIV infections.

  • The available data demonstrate that the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results.

Other considerations in the guidance include:

  • No change in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use.

  • Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently.

  • Blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.

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

Donating blood is one of several really important symbolic methods of demonstrating one’s caring for other people,” FDA Commissioner Robert M. Califf said. “We want to make that available to everyone possible in the context of a safe blood supply.”

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

Marks continued saying, “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,”

In the 1980s during the AIDS crisis, the FDA imposed a lifetime ban on donating blood for men who have sexual relations with men. The ban was officially enacted in 1985 with an emphasis on men who had sex with men going back to 1977. The FDA eased restrictions in 2015, allowing gay and bisexual men to donate blood if they abstained from sex in the previous year.

Due to a blood shortage during the COVID-19 pandemic, the FDA announced they would be shortening the restriction on gay and bisexual men who had not had sex within the past three months to donate. For decades LGBTQ+ rights groups and the medical community urged the FDA to lift restrictions.

In January 2022 former American Medical Association President Gerald E. Harmon, MD urged the FDA to lift restrictions calling them “discriminatory”.

“At issue is the need to evaluate all potential blood donors on an equal basis based on their individual risk factors and without regard to their sexual orientation or gender identity,” Harmon said.

Sarah Kate Ellis, President, and CEO of GLAAD called the FDA’s changes a tremendous leap forward toward elevating science over stigma.

“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.”

Ellis continued, “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. 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.“

In response to the FDA’s announcement The American Red Cross, one of the nation's largest suppliers of blood and blood products, issued a statement saying, “The Red Cross has worked for many years to change the deferral policy concerning men who have sex with men (MSM) – this work included decades of data collection and assessment on the impact to transfusion safety, ongoing advocacy to eliminate donor questions based on sexual orientation, and our recent role as a leading contributor in the FDA-funded ADVANCE Study.”

The statement continued by saying “The Red Cross also recognizes the hurt this policy has caused and that these are just the first steps in repairing relationships with the broader LGBTQ community.”

Watch the Full Press Conference Below:


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