The U.S. Food and Drug Administration announced a proposed guidance on Friday that would ease restrictions on blood donations by men who have sex with men.
The proposal will be subject to a public commenting period of 60 days, during which the agency will review and consider all comments before finalizing the guidance. If the agency passes the proposed guidance, it would then be implemented by the nation’s blood collection establishments through an updated donor history questionnaire.
Under the current policy — last updated in 2020 — men who have sex with men can donate blood if they haven't had sexual contact with other men for three months. The new proposed policy would eliminate the time-based restrictions on men who have sex with men and their female partners.
The proposed policy would screen potential donors' eligibility based on “gender inclusive, individual risk-based questions” that assess HIV risk. Anyone taking medications to treat or prevent HIV, including PrEP, would not be eligible.
“Whether it’s for someone involved in a car accident, or an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf, M.D. “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.”
According to the FDA, blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B, and hepatitis C. The FDA said this new proposal could increase the number of individuals eligible to donate blood, however, some would still be deferred from donating blood.
“Our approach to this work has always been and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
“We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”
