On Friday, the FDA proposed new guidelines that would remove the requirement that gay and bisexual men abstain from sex before donating blood.
Under the new proposed guidelines, time-based deferrals would be eliminated for men who have sex with men (MSM) and women who have sex with MSM.
“The US Food and Drug Administration today is proposing a change from time-based deferrals to using gender-inclusive, individual risk-based questions to assess blood donor eligibility to reduce the risk of transfusion-transmitted HIV,” the agency said. Statement Friday. “The proposal is in line with policies in place in countries such as the United Kingdom and Canada.”
“These draft recommendations are based on FDA’s careful review of available data, including data from other countries with similar HIV epidemiology that have established this approach and ongoing surveillance of the US blood supply. Based on available data, the agency believes that implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply. believes,” the agency continued.
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During the AIDS crisis in the 1980s, the FDA banned men who had sex with other men from donating blood again. In 2015, the agency eased the rule, allowing gay and bisexual men to donate blood if they had not been sexually active in the previous year, according to CNBC.
As a result of the shortage of blood donors during the Covid pandemic, the FDA further eased restrictions in April 2020, allowing gay and bisexual individuals who have not engaged in sexual activity within the past three months to donate blood.
“Whether it’s someone involved in a car accident, or someone with a terminal illness, donating blood saves lives every day,” said FDA Commissioner Robert M. Calif, MD said.
“Maintaining a safe and adequate supply of blood and blood products in the US is a top priority for FDA, and this proposal allows us to continue using the best science for individual risk assessment regardless of gender or sexual orientation,” 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 refine our policies so as to maximize who is eligible to donate blood while maintaining appropriate safeguards to protect recipients,” said Peter, MD, director of the FDA’s Center for Biologics. Marks, MD, Ph.D., Evaluation and Research.
“We will continue to follow the best available scientific evidence to maintain an adequate blood supply and reduce the risk of spreading infectious diseases and are committed to finalizing this draft guidance as soon as possible,” he continued.
Below is the new proposed guidance:
- Time-based deferrals are removed for men who have sex with men (MSM) and women who have sex with MSM.
- The current donor history questionnaire will 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 having more than one sexual partner in the past three months are then asked about a history of anal intercourse in the past three months.
- All prospective donors who report having a new sexual partner or having more than one sexual partner and who have had anal intercourse in the past three months are deferred from donation.
- Under this proposal, a prospective donor who does not report having a new or multiple sexual partner and having anal intercourse in the last three months, if he meets all other eligibility criteria, may be eligible to donate.
Other considerations in guidance include:
- There were no changes in donor deferment periods for individuals who exchanged sex for money or drugs, or for other HIV risk factors with a history of non-prescription injection drug use.
- Any person who has tested positive for HIV or has taken any medication to treat HIV infection will continue to be permanently deferred.
- Blood establishments are still required to screen all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.
Proposed guidance regarding pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP):
- Those taking oral medications to prevent HIV infection, such as PrEP or PEP, should postpone their last dose for up to three months.
- Those taking PrEP, an injection to prevent HIV infection, are deferred for two years from their most recent injection.
- Some blood establishments currently have deferral policies regarding the use of drugs to prevent HIV infection.
- Available data show that the use of PrEP and PEP can delay HIV detection by licensed screening tests for blood donation, potentially leading to false negative results.
FDA will allow 60 days for public comment on the proposal.
“The agency will review and consider all comments before finalizing this guidance, which will then be implemented by the nation’s blood collection organizations through an updated donor history questionnaire,” the agency said.
