The agency said it will recommend a series of “individual risk-based questions” that will be the same for every donor, regardless of sexual orientation, sex or gender.
Gay and bisexual men in monogamous relationships will be allowed to donate blood.
The FDA said blood donation establishments “may now implement” the new policy, but it is unclear how long it will take for donation centers to change their procedures. The agency did not set a deadline.
“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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, amid the COVID-19 pandemic, after the previous guidance had mandated a 12-month deferral period.
The new policy eliminates time-based restrictions in favor of what officials characterized as a more inclusive policy based on scientific evidence, while also maintaining the safety of the blood supply.
“The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” Marks said.
The move was praised by advocacy groups who had been pushing the FDA for decades to make a change.
