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- FDA Finalizes Recommendations Allowing Gay and Bisexual Men to Donate Blood
The Food and Drug Administration (FDA) published its final recommendations for assessing blood donor eligibility with a set of individual risk-based questions that reduce risk of transfusion-transmitted HIV and would also allow for monogamous gay and bisexual men to donate blood. The recommendations also reflect the CAP’s advocacy and comments to expand the number of people eligible to donate blood while also protecting the safety of the blood supply.
In its comments to the FDA, the CAP supported the use of individual risk-based questions instead of gender-based criteria to evaluate donors for risk of HIV and encouraged the FDA to continue monitoring blood donor and donation safety, as well as performing ongoing evaluations of donor regulations to be as inclusive as possible while maintaining transfusion safety. The FDA new policy eliminated time-based deferrals and screening questions specific to men who have sex with men and women who have sex with men who have sex with men.
Under the final guidance, all prospective blood donors would answer a series of individual, risk-based questions to determine eligibility, the FDA said. All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to 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.