CNN
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On Thursday, the US Food and Drug Administration paved the way for more gay and bisexual men to donate blood at the end of new risk based Recommendations for donating blood. In the future, potential donors will be asked the same set of questions regardless of their gender or sexual orientation.
Before the FDA began revising its guidance several years ago, gay and bisexual men faced a lifetime ban on donating blood, a move many considered 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 remove deferrals and specific screening questions for 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 United Kingdom and Canada, which have also implemented risk-based rules.
“It is going to make a more inclusive donation. It ensures that all donors are treated equally. Allow more people to have the opportunity to donate blood. So anytime more people can get into the donor pool safely, that’s a good thing. And this really is the beginning 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 serving 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 were 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 transmitting HIV, or human immunodeficiency virus, through donating blood. The FDA says it made the changes after reviewing data from other countries that have similar rates of HIV and have implemented risk-based eligibility for blood donations, information on the accuracy of HIV tests, information on surveillance of a system that controls past infections. by transfusions, and information on individual risk factors obtained from a government-funded study.
Under the new questions, anyone who has had a new sexual partner and anal sex, or who has had multiple sexual partners and anal sex, will be asked to wait at least three months after their most recent sexual contact to donate blood.
Anyone taking medication to treat or prevent HIV, such as PrEP, will also be deferred from donating. The FDA says that while HIV is not transmitted during sexual intercourse in people whose viral levels are undetectable, the same does not apply to donating blood. The blood is transfused directly into a vein and involves a larger volume of fluid, making it inherently more risky than sexual contact.
The FDA advises against stopping HIV medication or PrEP to donate blood.
The agency says the industry guidance is a recommendation. Blood banks are not required to follow it, so policies may differ slightly from place to place. However, the FDA has to approve the language used in the donor history questionnaires, so most blood banks follow their recommendations.
“The FDA has worked diligently to review our policies and ensure that 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 Biological Research and Evaluation.
Marks said the agency would continue to closely monitor the safety of the US blood supply after the rules are implemented.
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