The Food and Drug Administration is drafting new guidelines that will allow gay and bisexual men in monogamous relationships to donate blood without abstaining from sex, The Wall Street Journal reported.
Since the AIDS epidemic during the 1980s — when tests for HIV were not considered sensitive enough to protect the blood supply — men who had sex with men were barred for many years from donating blood.
That ban was lifted in 2015, but the FDA said gay and bisexual men needed to abstain from sex for one year before donating.
Federal officials then shortened the abstinence requirement to three months amid blood shortages during the COVID pandemic.
The WSJ reported Wednesday that sources said the FDA plans to issue the new rules in coming months.
Under the new guidelines, potential donors would need to complete an individualized risk assessment — similar to that used in Canada, which asks uniform questions regardless of gender or sexual orientation about a potential donor's medical history, travel and sexual activity.
WSJ sources said that FDA officials still are drafting the new guidelines and are determining what the questionnaire would contain. The new risk assessment likely would ask potential donors if they've had any new sexual partners in the past three months.
People who say they haven't would be free to donate blood, WSJ reported. People who say they have had new sexual partners would be asked if they have had anal intercourse in the past three months. People who say they haven't would be allowed to donate. People who say they have would likely be asked to wait three months before donating blood, an FDA official said.
The FDA spent money to study whether an individualized-risk assessment would be as effective as time deferrals in keeping the blood supply safe. Vitalant, OneBlood and the American Red Cross conducted the study, which ended earlier this year.
Participants in the study were asked questions that included whether they had more than one sex partner during specific periods of time, and whether they used condoms.
"We have a strong data set," Dr. Brian Custer, director of Vitalant Research Institute and principal investigator of the study, told WSJ. "We have highly relevant information to envision what an individual risk-based approach would look like."
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