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FDA proposes easing blood donation rules for gay and bisexual men

Under current rules, the FDA restricts donations from gay and bisexual men if they have had sex with another man in the past three months.
A person donates blood in the LA Kings blood mobile in Los Angeles
A blood donation in Los Angeles last January, when the American Red Cross declared its first national blood crisis. Patrick T. Fallon / AFP via Getty Images file

The Food and Drug Administration on Friday proposed easing blood donation guidelines for gay and bisexual men.

Under current rules, the FDA allows donations from gay and bisexual men if they haven't had sex with another man for three months.

In a draft proposal posted to the agency's website, the FDA said the new rules would allow anyone to donate blood — regardless of gender or sexual orientation — as long as they haven't engaged in certain sexual behaviors in the last three months.

That would mean most gay and bisexual men who are in a monogamous relationship with another man will no longer need to abstain from sex to donate blood.

"This is a great first step in getting in the right direction," Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said on a call Friday. The new rules, he said, are consistent with those of Canada and the United Kingdom.

Under the new guidelines, blood donors who report having a new sexual partner or more than one sexual partner would be asked about their sexual activity over the last three months.

People taking oral medications to prevent HIV, such as PrEP, and people who have recently had sex in exchange for money or drugs would be subject to a three-month deferral period under the FDA proposal. Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection.

People with HIV, including those who take medication that drastically reduces their viral load, would still be asked to not donate blood.

“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 Dr. Robert Califf said in a statement.

On Friday’s call, Califf said donating blood is “one of several really important symbolic methods of demonstrating one caring for other people.”

The agency's restrictions on blood donations from gay and bisexual men stem from the AIDS crisis, which began in the early 1980s, when little was known about the virus.

As of 2019, an estimated 1.2 million people in the United States had HIV, according to the Centers for Disease Control and Prevention.

Advocacy groups and medical organizations, including the American Red Cross, have urged the FDA to lift restrictions on blood donations for gay and bisexual men, saying the practice is discriminatory and has contributed to shortages in the blood supply in the United States.

A report from the Williams Institute, a think tank at UCLA School of Law, found that if the FDA were to lift donor bans for men who have sex with men, the annual blood supply would increase by 2 to 4%, or 345,400 to 615,300 pints of blood annually.

The FDA is not expected to reach a final decision until after a 60-day public comment period.

Marks, of the FDA, said the agency plans to work with blood collectors during the comment period to help them make any necessary changes needed to implement the new rules.

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