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


The US Food and Drug Administration finalized Thursday paving the way for more gay and bisexual men to donate blood. new risk based Recommendations for blood donation. Going forward, potential donors will be asked the same set of questions regardless of their gender or sexual orientation.

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

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

“It’s going to make donation more inclusive. It makes sure all donors are treated equally. It gives more people the opportunity to donate blood. So ever more people can safely enter the donor pool.” are able to do, it’s a good thing. And it’s really the start of a new era of blood donor eligibility,” said Susan Forbes, senior vice president of corporate communications 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 need to update its donor history questionnaire. “So there were a lot of regulatory steps to do, 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 HIV rates and have implemented risk-based qualification for blood donations, information on the accuracy of tests to detect HIV, Monitoring information from infection monitoring systems. Information on personal risk factors derived from transfusion, and from government funded studies.

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

Anyone taking medications to treat or prevent HIV, such as PrEP, will also be disqualified from donations. The FDA says that although HIV is not transmitted during sex between people whose viral levels are undetectable, this does not apply to blood donations. Blood is transfused directly into a vein and involves a large amount of fluid, making it inherently riskier than sexual contact.

The FDA advises donating blood against HIV medication or PrEP.

Sarah Kate Ellis, president and CEO of the Gay and Lesbian Alliance Against Defamation, GLAAD, said the new recommendations signal “the beginning of the end of a dark and discriminatory past rooted in fear and homophobia,” but argued that people taking PrEP should Except, they didn’t go far enough.

“Putting potential blood donors in a separate line for those taking PrEP from every other donor adds unnecessary stigma. In fact, the biases embodied in this policy can cost lives.” Ellis wrote in a statement posted on his organization’s website. GLAAD urges the FDA to prioritize science over stigma and treat all donors and all blood equally, it said in the statement.

The FDA says the guidance for industry is a recommendation. Blood banks are not required to follow this, so policies may vary slightly from place to place. The FDA has to approve the language to be used on the donor history questionnaire, however, most blood banks follow its recommendations.

“FDA has worked diligently to evaluate our policies and ensure that we have the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. There are proofs. Implementation of these recommendations will mark an important 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 will continue to closely monitor the safety of the US blood supply once the rules go into effect.

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