FDA updates discriminatory guidelines; new set of risk-based rules in place applicable on all prospective donors
The United States Food and Drug Administration on May 11, 2023 eased restrictions on blood donations that only applied to gay, bisexual and pansexual men and their women partners. The policy has now been updated and the new set of risk-based rules is applicable to all prospective donors.
The questions to assess blood donor eligibility will be the same for every donor, regardless of sexual orientation, sex or gender. The federal agency of the department of health and human services recommended that blood establishments revise their donor history questionnaires and procedures.
The restrictions were implemented in the 1980s to reduce the risk of transfusion-transmitted human immunodeficiency virus or HIV. The guidelines prohibited men who have sex with men from donating blood, but with the caveat, they had to abstain from sex for at least a year before donating.
The updated policy will expand the number of people eligible to donate blood while maintaining the appropriate safeguards to protect the safety of the blood supply, the FDA said on its website. The agency had first proposed easing the sexual abstinence criteria for blood donation in January.
“The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The older policy had time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM.
All prospective donors who report having a new sexual partner or more than one sexual partner in the past three months would be deferred, according to the updated policy. The deferral would also be applicable to those who have had anal sex in the past three months.
The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place
The deferral will reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing.
The updated guidelines are similar to the ones followed in the United Kingdom and Canada at present, the FDA further said.
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