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.
Below is the new proposed guidance:
The time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.
The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months.
All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.
Under this proposal, a prospective donor who does not report having new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
Other considerations in the guidance include:
No change in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use.
Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently.
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.
Proposed guidance related to pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP):
Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose.
Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection.
Some blood establishments currently have deferral policies related to the use of medications to prevent HIV infections.
The available data demonstrate that the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results.
The FDA will allow for 60 days of public comment on the proposal.
“The agency will then review and consider all comments before finalizing this guidance, which would then be implemented by the nation’s blood collection establishments through an updated donor history questionnaire,” the agency said.
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