FDA proposes relaxing blood donations for gay/bi men

Image by Ahmad Ardity from Pixabay

The Food and Drug Administration (FDA) on Friday announced draft rules that would relax time restrictions on blood donations from gay and bisexual men.

In their announcement, the FDA said new language would use gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. The change would bring U.S. standards in line with those in the U.K. and Canada.

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. 
  • 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. 
  • Under this proposal, a prospective donor who does not report having new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.    

“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 Robert M. Califf, M.D. “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.” 

The announcement has been welcomed by politicians and activists.

“Urging the FDA to listen to the science and update their discriminatory blood donation guidance has been my mission for fourteen years. While we have made gradual progress throughout those years, today’s announcement is our most significant step yet. This updated guidance is a critical component in the fight for expanded LGBTQI+ rights,” said U.S. Rep. Mike Quigley (D-Chicago).

“The new FDA guidance and proposed regulations are a huge step forward to ending stigma against the LGBTQI+ community,” said Lambda Legal HIV Project Director Jose Abrigo. “We applaud the decision to screen potential blood donors according to individual risk factors regardless of gender or sexual orientation.”

Abrigo also said that more work needs to be done to follow the science, make the risk assessment factors more inclusive and fair, and further expand the ability of everyone safely able to do so to donate blood.

Sarah Kate Ellis, President and CEO of GLAAD, said, “These changes are 40-plus years in the making, and are 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 said that the change would reduce discrimination against LGBTQ people, help alleviate the national blood shortage, and opens the door for all eligible LGBTQ people to give blood.

The FDA banned all blood donations from gay and bisexual men in the 1980s because of concerns over HIV transmission. The ban was lifted in 2015 but restrictions remained. In 2020, during the height of the COVID-19 pandemic, the waiting period for men who have sex with men was changed from a full year to three months. It has remained at a three-month waiting list since then.

Congress has pushed for the FDA to remove the restrictions in 2021 and 2022.