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FDA Will Now Allow Blood Donations From Gay, Bisexual Men and Transgender Women

The new FDA rules on blood donation will be more gender-inclusive, the agency said.

A phlebotomist tends to the arm of a blood donor at the KFC YUM! Center during the Starts, Stripes, and Pints blood drive event on July 7, 2021, in Louisville, Kentucky.

The Food and Drug Administration (FDA) announced on Thursday that it will be ending a longstanding blood donation policy that discriminates against gay and bisexual men, as well as some transgender women.

Restrictions on those groups have been in place for decades. In 1985, the FDA mandated an “indefinite deferral” of gay and bisexual men giving blood, citing the higher prevalence of HIV infections in the gay community during that time, despite the fact that the disease can be transferred regardless of gender or sexual orientation.

The policy was changed in 2015, allowing gay and bisexual men to give blood if they abstained from sex for a full year. In 2020, during the height of the COVID-19 pandemic, that time period was shortened to three months.

The proposal announced this week will use “risk-based questions to reduce the risk of transfusion-transmitted HIV,” rather than assuming the level of risk based on a person’s gender or sexual orientation, the FDA 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,” FDA Commissioner Robert M. Califf said.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, also commented on the new policy.

“Our approach to this work has always been, and will continue to be, based on the best available science and data,” Marks said, adding that the agency “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adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”

Instead of focusing on a person’s gender or sexual orientation, a pre-screening questionnaire will ask about sexual history and the number of partners a person has. People with multiple partners will be deferred from giving blood until they have only one sexual partner for a three-month period, per the agency’s new guidelines.

The changes to the FDA’s rules on blood donation will require a public comment period before they are officially implemented, a process that usually takes around two months. The new rules could be in place as early as this spring.

Many celebrated the rule change, but noted that there were still issues with the policy.

The “FDA announcement is HUGE … This is what progress and advocacy looks like,” Tony Morrison, senior director for communications of GLAAD, said on Twitter in response to the announcement.

“This is absurdly late, but thank god, finally,” journalist Lauren Wolfe tweeted, adding that the rules only permitting monogamous people to donate were “still awful.”

Jay Franzone, communications director of the National Gay Blood Drive, noted that some of the new rules discouraged safe sex practices for gay and bisexual men. The new policy would deny gay men who are taking pre-exposure prophylaxis (PrEP) medication — meant to prevent HIV infection due to accidental exposure — from giving blood until they stop taking the medicine for three months.

“One step forward, another back,” Franzone commented. “While the FDA is now using an individualized risk-based approach, they’re essentially punishing people who take PrEP to prevent HIV infection.”

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