The U.S. Food and Drug Administration (FDA) has officially adopted new guidelines that loosen restrictions on blood donations from men who have sex with men (MSM). The new guidelines will most benefit monogamous men who aren’t taking any HIV treatment or HIV prevention medications.
The new FDA guidelines require a three-month pre-donation celibacy period for anyone who has had sex with a new sexual partner, more than one sexual partner, or anal sex. This is to reduce the likelihood of donations by people with new or recent HIV infections, the FDA said. Blood donation organizations test all donated blood for transfusion-transmitted infections, including HIV, hepatitis B, and hepatitis C.
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The guidelines also require a three-month pre-donation abstinence period for people who have anal sex or take pre-exposure prophylaxis (PrEP) medication and a two-year abstinence period for users of injectible PrEP. PrEP can mask the presence of HIV in blood.
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“The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA statement on its new guidelines. The statement also said, “Individuals should not stop taking their prescribed medications, including PrEP, or PEP (post-exposure prophylactics), in order to donate blood.”
In 1985, in response to the AIDS epidemic, the FDA instituted a lifelong ban on donors who were men who have sex with men (MSM). Then, in 2005, the FDA used began requiring MSM to abstain from anal sex with same-sex partners (with or without a condom) for one year before donating blood. Straight people, on the other hand, could have unprotected sex with opposite-sex partners and donate whenever they liked. In April 2020, the FDA changed the MSM abstinence period from one year to 3 months in response to declining donations at the start of the COVID-19 pandemic.
The newly adopted guidelines take an “individualized assessment approach,” asking all donors, regardless of gender, about their sexual partners and activities, the FDA said. The FDA would keep in place its permanent ban on HIV-positive blood donors as well as its current prohibitions against non-prescription IV drug users and sex workers who trade sex for money or drugs.
In a statement, Sarah Kate Ellis, president and CEO of GLAAD, said that the new guidelines “signals the beginning of the end of a dark and discriminatory past rooted in fear and homophobia.”
However, Ellis added, “The deferral period for individuals on PrEP, an FDA-approved drug proven to prevent HIV acquisition, continues to erect barriers to LGBTQ blood donors. Placing potential blood donors taking PrEP in a separate line from every other donor adds unnecessary stigma. The bias embedded into this policy may, in fact, cost lives. GLAAD urges the FDA to continue to prioritize science over stigma and treat all donors and all blood equally.”
The new guidelines were based on studies, including a recent data analysis from major U.S. blood donation organizations, as well as a review of gender-inclusive policies from the United Kingdom and Canada.
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