On Friday, the FDA proposed new guidelines that would remove the restriction that gay and bisexual men in monogamous relationships abstain from sex before donating blood.
Under the new proposed guidelines, time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.
“The U.S. Food and Drug Administration today announced it is proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV,” the agency said in a statement Friday. “This proposal is in line with policies in place in countries like the United Kingdom and Canada.”
“These draft recommendations are based on the FDA’s careful review of available information, including data from other countries with similar HIV epidemiology that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply. Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply,” the agency continued.
During the AIDS crisis in the 1980s, the FDA banned men who had sex with other men from ever donating blood again. In 2015, the agency eased the rule, making it possible for gay and bisexual males to donate blood if they had not engaged in sexual activity during the previous year, according to CNBC.
As a result of a shortage of blood donors during the Covid pandemic, the FDA further eased restrictions in April 2020, allowing gay and bisexual individuals who had not engaged in sexual activity within the past three months to donate blood.
“Whether it’s for someone involved in a car accident, or for 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,” he added.
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,” he continued.
