FDA drafts new ‘gender-inclusive’ guidance on blood donation eligibility, HIV risk reduction

The Food and Drug Administration (FDA) has issued draft guidance to change its policies on donating blood, moving away from time-based deferrals for men who sex with men and instead proposing “individual risk-based questions” to reduce the potential spread of HIV through transfusions.

Under current FDA guidelines for donating blood, men who have sex with men are permitted to donate blood after a three-month deferral period in which they abstain from sexual encounters with men. This change was made in 2020 after the previous guidance had mandated a 12-month deferral period.

The new question-based approach would instead ask potential donors about new or multiple sex partners they have had in the past three months. Those who have had a new sexual partner or more than one in that time frame would be deferred if they reported having anal sex.

“Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so,” FDA Commissioner Robert Califf said in a statement.

Individuals taking oral medications to prevent HIV will be subjected to a three-month deferral period starting from their last dose, while those receiving injectable PrEP would be subject to a two-month deferral period.

Those who have not had any new sexual partners or more than one in the past three months would be eligible to donate as long as they meet all other criteria.

The deferral policy would stay in place for those who have exchanged sex for money or drugs as well as those who have a history or injecting non-prescription drugs.

The FDA’s draft guidance would put the U.S. in line with other Western countries such as the U.K. and Canada.