The Food and Drug Administration (FDA) changed its policies on Thursday to allow gay and bisexual men to donate blood.
Under the agency’s new guidelines, all donors will undergo an individualized risk assessment to reduce the risk of transfusion-transmitted HIV.
“These questions will be the same for every donor, regardless of sexual orientation, sex or gender,” the FDA said in its announcement. “Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.”
The changes mean that men who have sex with men will no longer have time-based deferrals or screening questions specific to their sexual orientation.
“All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing,” the agency said.
Prospective donors taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP)), will also be deferred. The FDA said that individuals should not stop taking their prescribed medications, including PrEP, or PEP, in order to donate blood.
The changes were celebrated as a “milestone” for the LGBTQ community by Peter Marks, M.D., PhD., director of the FDA’s Center for Biologics Evaluation and Research.
“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. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” Marks said in the announcement released by the agency. “The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place.”
Men who have sex with men were barred from donating blood during the 1980’s AIDS epidemic, aiming to prevent the spread of HIV through the blood supply. In 2015, the ban was changed to a one year of abstinence requirement.
