The U.S. Food and Drug Administration has announced that it is lifting longstanding categorical restrictions preventing sexually active gay and bisexual men from donating blood.
The FDA has issued draft recommendations for donor eligibility criteria, under which donor eligibility will be determined based on an individualized risk assessment, similar to the way donors are screened in countries like the United Kingdom and Canada.
All potential donors, regardless of gender or sexual orientation, will be asked to complete a donor history questionnaire.
Based on those responses, blood collectors will determine whether the individual needs to be deferred from donating for a three-month period. Only people diagnosed with, and taking treatment for, HIV, are banned from donating for life.
The questionnaire will ask donors about various behaviors that place them at higher risk of acquiring bloodborne pathogens that would make them ineligible to donate or could potentially compromise the safety of the blood supply.
One of those questions will ask if a person has had any new sexual partners in the past three months. Those who answer no will be permitted to give blood.
Those with new sexual partners in the past three months will then be asked if they’ve engaged in anal intercourse in the past three months, with only those who answer affirmatively being asked to “defer” donating for three months.
Deferral periods will remain in place for other HIV risk factors, such as individuals who have exchanged sex for money or drugs, or have a history of non-prescription injection drug use, or those who have tested positive for or been treated for STDs such syphilis or gonorrhea.
Those taking pre-exposure prophylaxis — daily medication that reduces a person’s risk of contracting HIV — are barred from donating as long as they are on the drugs. Those taking PrEP orally are deferred for three months after their last dose, and those receiving injectable PrEP are deferred for two years from their last injection.
Blood establishments will still be required to test all blood donations for evidence of HIV, hepatitis B, and hepatitis C, which provides an additional level of safeguards to ensure the blood supply is safe.
By moving to an individualized risk assessment, categorical deferrals would be eliminated for men who have sex with men, as well as women who engage in sex with men who have sex with men.
Monogamous couples, particularly gay and bisexual men in monogamous relationships, will be able to donate blood or blood products under the proposed screening criteria. Previously, those groups were asked to abstain from sex for at least three months before donating.
The FDA’s decision to lift the categorical restrictions on those groups — particularly gay and bisexual men — follows years of pressure from LGBTQ activists, blood banks, and even the American Medical Association, which previously called for adopting a risk-based assessment.
LGBTQ advocates, in particular, argued that the restrictions on gay and bisexual men were discriminatory and unfair, as men who had multiple female sexual partners within a 3-month window were permitted to donate, regardless of whether they were engaging in higher-risk sex practices.
They also argued that technological advancements in blood screening — including a smaller “window period,” or the time it would take for disease antibodies to show up in blood or plasma, of 10 to 33 days — rendered the categorical-based three-month deferrals moot.
The deferrals were preceded by a lifetime ban on gay and bisexual men donating, which was imposed in 1985, during the AIDS epidemic, after scientists became aware that HIV could be transmitted by blood and was more easily spread during anal sex.
Under those guidelines, any man who had ever had sex with another man dating back to 1977 was “indefinitely deferred” from donating.
That policy remained in place until 2015, when the FDA lifted the lifetime ban and replaced it with a 12-month deferral period for gay and bisexual men.
That deferral period was later reduced to three months in 2020, during the COVID-19 pandemic, when blood shortages became more severe, and there was increased demand for plasma taken from survivors of COVID-19, which could be used to treat those with more severe forms of the disease.
Last year, the Biden administration indicated it was open to scrapping the current categorical three-month deferral period for gay and bisexual men and replacing it with individualized risk screenings.
The draft recommendations will now enter a period of public comment, after which they may or may not be amended before the finalized donation rules are adopted.
The changes in donation criteria are unlikely to go into effect until later this year or early next year, after the final rules have been adopted and blood banks can begin implementing the new changes, retraining staff, and undertaking outreach campaigns to educate and inform gay and bisexual men in monogamous relationships of the change in eligibility criteria, reports The Washington Post.
The FDA funded a study, conducted by three of the nation’s largest nonprofit blood centers — Vitalant, OneBlood, and the American Red Cross — between December 2020 and September 2022 in order to examine questions that might be asked on an individualized risk assessment.
Brian Custer, director of the Vitalant Research Institute and the study’s principal investigators, declined to share the results without FDA approval, but characterized the study’s findings as promising.
In defending its decision to adopt the universal risk-based assessment — which is likely to draw criticism from conservatives and those who believe the federal government is pandering to the LGBTQ community — the FDA noted that it based the change, in part, on data from other countries that have instituted a risk-based screening for potential blood donors. This led the agency to believe that a universal donor questionnaire will not compromise the safety or availability of the blood supply.
“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,” FDA Commissioner Dr. Robert Califf said in a statement. “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.”
Some activists say gay men would still be treated unfairly under the proposed guidelines, due to their tendency to engage in anal sex. As such, those with new or multiple partners will effectively still have to abstain from sex for three months prior to donating.
Individuals on PrEP are barred as long as they continue to receive the medication, and there are no exceptions for sexually active people who consistently wear condoms, or those who provide proof of a negative HIV test.
“Being monogamous with someone who is not living with HIV is not the only way to prevent transmission,” Jason Cianciotto, vice president for communications and public policy at the New York-based Gay Men’s Health Crisis, told the Post.
The Human Rights Campaign, the nation’s largest LGBTQ advocacy organization, commended the change in donation criteria as a positive step toward progress while criticizing other aspects of the new guidance and calling on policymakers to “refine” the donor recommendations.
“This proposed blood donation policy moves the country toward what LGBTQ+ advocates and medical experts have been saying for years — that a science-based, individualized risk assessment is the best, most equitable way to ensure safety of the blood supply while reducing unnecessary discrimination against gay, bisexual, and other men who have sex with men,” Kelley Robinson, the organization’s president, said in a statement.
“This new policy removes a decades-long barrier for many in our community — and there is more to do to ensure gay, bisexual and transgender people are no longer unfairly stigmatized when they try to donate blood,” Robinson continued.
She also noted flaws in the new guidelines, such as a focus on the number of sexual partners a potential donor has rather than new partners — whose medical histories a donor may not be familiar with — and the effective ban on any person taking PrEP as prevention against HIV.
Sarah Kate Ellis, the president and CEO of GLAAD, praised the change as a development “40-plus years in the making” and a “tremendous leap forward toward elevating science over stigma.”
“GLAAD and leading medical experts have long been advocating for guidelines that see and treat LGBTQ people the same as any other person, including as potential donors who want to help others,” Ellis said in a statement. “The announcement today will ease historic discrimination against LGBTQ Americans, help alleviate the national blood shortage, and opens the door for all eligible LGBTQ people to give blood and save lives.”
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