FDA paves way for more gay and bisexual men to donate blood with new risk-based assessment

Originally Published: 11 MAY 23 09:53 ET
Updated: 11 MAY 23 15:45 ET
By Brenda Goodman, CNN

(CNN) -- US Food and Drug Administration on Thursday paved the way for more gay and bisexual men to donate blood by finalizing new risk-based recommendations for blood donation. Going forward, prospective donors will be asked the same set of questions regardless of their sex or sexual orientation.

Before the FDA began taking a second look at its guidance several years ago, gay and bisexual men had faced a lifetime ban on blood donation, a move that many said was discriminatory. The most recent policy recommended that men who have sex with men wait three months after sexual contact with other men before they could donate blood.

The policy changes eliminate deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. It brings the United States in line with other countries such as the UK and Canada, which have also implemented risk-based rules.

"It's going to make a donation more inclusive. It ensures that all donors are treated equally. It enables more people the opportunity to donate blood. So anytime more people are able to enter the donor pool safely, that is a good thing. And this really is the start of a new era of blood donor eligibility," said Susan Forbes, senior vice president of corporate communication and public relations for OneBlood, a system of blood collection centers that serves hospitals in the Southeast.

Forbes said OneBlood is moving quickly to implement the new guidance, which means it will have to update its donor history questionnaire. "So there was a lot of regulatory steps to do it, but we're doing it as quickly as possible," Forbes said.

The new questions are designed to reduce the risk of transmission of HIV, or human immunodeficiency virus, through blood donation. The FDA says it made the changes after reviewing data from other countries that have similar rates of HIV and that have implemented risk-based eligibility for blood donations, information on the accuracy of tests to detect HIV, surveillance information from a system that monitors infections passed by transfusions, and information on individual risk factors gleaned from a government-funded study.

Under the new questions, anyone who had a new sexual partner and anal sex, or who had multiple sexual partners and anal sex, would be asked to wait at least three months from their most recent sexual contact to donate blood.

Anyone taking medications to treat or prevent HIV, such as PrEP, would also be deferred from donation. The FDA says that although HIV is not transmitted during sex in people whose viral levels are are undetectable, the same does not apply to blood donation. Blood is transfused directly into a vein and involves a larger volume of fluid, making it inherently riskier than sexual contact.

The FDA advises against stopping HIV medication or PrEP to donate blood.

The agency says the guidance to industry is a recommendation. Blood banks aren't required to follow it, so policies may differ slightly from place to place. The FDA does have to approve the language used on donor history questionnaires, however, so most blood banks hew to its recommendations.

"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 Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

Marks said the agency would continue to closely monitor the safety of the US blood supply after the rules are implemented.

The-CNN-Wire
™ & © 2023 Cable News Network, Inc., a Warner Bros. Discovery Company. All rights reserved.