FDA to make it easier for gay and bisexual men to donate blood: Schott

An expected FDA policy change will make it easier for men who have sex with men to donate blood.

Toby Talbot/AP

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Toby Talbot/AP

An expected FDA policy change will make it easier for men who have sex with men to donate blood.

Toby Talbot/AP

Updated at 12:55 PM ET

The U.S. Food and Drug Administration on Friday released draft guidance to ease restrictions on blood donations by men who have sex with men.

This change will be effective after a public comment period.

Blood donation restrictions date back to the early days of the AIDS epidemic and were designed to protect the blood supply from HIV. Originally, gay and bisexual men were forbidden to donate blood. Over time, the FDA relaxed the lifetime ban, but still maintained some restrictions.

Under the current policy, last updated in 2020, men who have sex with men can donate blood if they haven’t had sexual contact with another man for three months.

A newly proposed policy would eliminate time-based restrictions on men having sex with men (and their female partners) and instead replace potential HIV risk assessments based on a series of questions that assess HIV risk, regardless of gender. screening for donor eligibility. People taking medication to treat or prevent HIV, including PrEP, are not eligible.

A risk assessment includes questions about anal sex. Donors who may have had anal sex with a new sexual partner or multiple sexual partners within the past three months are not eligible to donate blood.

The change aims to address criticism that the current policy is discriminatory and outdated, and another barrier to strengthening the country’s blood supply. are routinely tested for HIV.

At a briefing on Friday, Dr. Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research, said:

“We will continue to work to ensure that all those who wish to donate do so within the limits of what is scientifically accepted and to establish policies to ensure the safety of the blood supply.”

In developing the new guidance, the FDA focused on the results of a survey of approximately 1,600 gay and bisexual men who were screened to identify potential donors most likely to be infected with HIV. created a question.

Reactions to the news from advocates, medical groups and blood banks have been positive.

“The blood industry is very excited about the proposed changes,” said Kate Fry, CEO of America’s Blood Centers. “We have been advocating for a move to an individualized risk assessment model, she has been advocating for 10 years, so this has been very welcome to blood centers across the country.”

She emphasized that all donated blood is carefully screened for HIV and that testing has improved dramatically to ensure the safety of the blood supply.

Over the years, the American Medical Association, the American Red Cross, and LGBTQ+ advocacy groups have called for changes to federal rules about donating blood.

“These changes have taken more than 40 years to make, and they represent a giant leap forward in overcoming stigma and advancing science,” said Tony Morrison, spokesman for advocacy group GLAAD. increase.

However, GLAAD and other groups say this change is not yet sufficient. They argue that some of the remaining restrictions remain unnecessary and stigmatizing, such as a ban on donations by people taking the drug PrEP to prevent HIV.

“Limiting and procrastinating people who are actively working on their sexual health stigmatizes them. It’s risky, and that’s categorically false,” says Morrison.

So his group will continue to push the FDA to loosen regulations further.

Proposed changes to blood donation rules are open for public comment for 60 days. The FDA will then consider these comments and issue a final rule, likely later this year. So monogamous gay men may start donating blood again in 2023.