FDA eases rules again for gay and bisexual men seeking to donate blood

WASHINGTON– The US is working to ease restrictions on blood donations from gay and bisexual men and other groups traditionally at higher risk of HIV.

The Food and Drug Administration on Friday announced draft guidelines that would remove the current three-month abstinence requirement for donations from men who have sex with men. Instead, potential donors would be screened with a questionnaire that assesses their individual HIV risks based on sexual behavior, recent partners and other factors.

If complete, the postponement would be the FDA’s latest move to expand donor eligibility, with the potential to boost the U.S. blood supply.

Gay rights groups have long opposed blanket restrictions on who can donate blood, saying they discriminate against the LGBTQ community. Medical societies, including the American Medical Association, have also stated that such exclusions are unnecessary given technological advances in testing blood for infectious diseases.

“Current and past blood donation guidelines have made unfounded assumptions about gay and bisexual men and really tangled people’s identities with their likelihood of having HIV,” said Sarah Warbelow of the Human Rights Campaign, an LGBTQ advocacy group.

The United States and many other countries began blocking blood donations from gay and bisexual men during the AIDS epidemic in the early 1980s to prevent the spread of HIV through the blood supply.

In 2015, the FDA lifted the lifetime ban and replaced it with a one-year abstinence requirement. Then in 2020, the agency shortened the abstinence period to three months after donations plummeted during the COVID-19 pandemic.

Regulators said there have been no negative impacts on the blood supply as a result of these changes.

The FDA establishes requirements and procedures for blood banks across the United States. All potential donors answer questions about their sex history, drug use, and recent tattoos or piercings, among other factors that may contribute to the spread of blood-borne infections. The donated blood is then tested for HIV, hepatitis C, syphilis and other infectious diseases.

As part of the new questionnaire, men who have sex with men are asked about new or multiple partners in the last three months. Those who answered yes to both questions and also indicated having had anal sex would be barred from donating until a later date. The policy would also apply to women who have sex with gay or bisexual men.

The policies reflect those used in Canada and the UK

The FDA based its latest proposal on a recent study of 1,600 gay and bisexual men. The FDA-funded study compared the effectiveness of a detailed, personalized sexual behavior questionnaire versus current time-based abstinence rules.

It will take several months for blood banks to make the changes, according to Cliff Numark, an executive at Vitalant, a blood center that participated in the study. The changes require new questionnaires, staff training and computer software updates.

The Red Cross said it supports the FDA’s changes, but added that it’s too early to know if they will lead to more blood donations.

Lukas Pietrzak, of Washington DC, said he volunteered for the FDA study. He credits emergency blood transfusions with saving his father’s life after a bicycle accident in 1991.

Pietrzak donated blood in high school but was not admitted after becoming sexually active as a gay man.

“Until I fully came out to my friends, I had to grapple with why I never went to donate blood with them,” says Pietrzak, 26, who now works for the federal government.

If blood donations are called for, “we can now participate,” said Pietrzak.