The updated guidelines do away with a requirement that men who have sex with men abstain from sex for three months prior to giving blood.
The US Food and Drug Administration has removed a decades-long ban on sexually active gay and bisexual men from donating blood, overruling a restriction dating back to the 1980s AIDS crisis. Now the gay and bisexual men in monogamous relationships can give blood in the US without abstaining from sex, according to its latest guidelines issued on May 14.
The updated guidelines do away with a requirement that men who have sex with men abstain from sex for three months prior to giving blood.
The FDA, an agency within the US Department of Health and Human Services, is responsible for the safety and security of the country’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
In a statement the FDA 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. This proposal is in line with policies in place in countries like the United Kingdom and Canada, the statement says.
“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. “Maintaining a safe and adequate supply of blood and blood products in the US 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.”
Under the new proposed guidance, the time-based deferrals for men who have sex with men (MSM) and women who have sex with women 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.
Similarly, 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.
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.
“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, director of the FDA’s Center for Biologics Evaluation and Research.
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