The U.S. Food and Drug Administration (FDA) has proposed changes that would loosen restrictions on blood donations from men who have sex with other men (MSM).
The FDA’s proposal would eliminate its current mandatory three-month celibacy period for MSM and women who have sex with MSM. However, it would still require people who have anal sex or take pre-exposure prophylaxis (PrEP) medication to abstain from doing either three months before donating.
As such, the policies could predominantly cause MSM to continue to be rejected as blood donors.
The FDA used to require 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 like. 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 new proposal would take an “individualized assessment approach,” asking all donors, regardless of gender, about their sexual partners and activities over the last three months.
“All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation,” the FDA wrote in a statement about its proposal. This would apply whether or not the sex involved a condom.
Because PrEP can mask the presence of HIV in blood — resulting in false negative results — HIV-negative people taking oral PrEP meds would have to abstain from doing so for three months. People taking injectable PrEP would have to abstain from doing so for two years.
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. Blood donation organizations will still test all blood for transfusion-transmitted infections, including HIV, hepatitis B, and hepatitis C.
The new proposals 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. The proposed policy will be subject to a 60-day public comment period, then subject to revision by the FDA.
LGBTQ Nation contacted the FDA to ask whether the government agency thinks the proposed changes will predominantly discourage MSM from donating. The FDA responded, “We expect that some MSM who are currently deferred would be eligible to donate under the new policy, and that anyone at risk of HIV infection would be deferred under this individual risk assessment.”
However, in a statement issued Friday, the Human Rights Campaign (HRC) wrote that “aspects of the proposed new policy still require refinement,” particularly concerning PrEP use.
“It is also unfortunate that the new policy continues to ban those on PrEP from donating blood,” HRC President Kelley Robinson wrote. “PrEP is the most powerful weapon we have to protect individuals from contracting HIV and to eventually wipe out the disease entirely. The fact that being on PrEP can conceal HIV positivity is accurate, but there is a solution on the horizon thanks to technologies being developed that would inactivate pathogens in the blood.”
UPDATE: This article was updated to include a comment from the FDA.