WASHINGTON (AP) — The United States is moving to further ease restrictions on blood donations from gay and bisexual men and other groups who typically face higher HIV risks.
The Food and Drug Administration on Friday announced draft guidelines that would eliminate the current three-month abstinence requirement for donations from men who have sex with men. Instead, all potential donors would be screened with a new questionnaire that assesses their individual HIV risks based on sexual behavior, recent partners and other factors.
If finalized, many gay and bisexual men in monogamous relationships would be able to donate blood for the first time in decades. It’s the FDA’s latest move to broaden donor eligibility, with the potential to increase donations.
“We are confident that the security of the blood supply will be maintained,” Dr. Peter Marks of the FDA.
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 said such exclusions are unnecessary given advances in technology for testing blood for infectious diseases.
“Current and previous blood donation policies made unfounded assumptions about gay and bisexual men and really embarrassed people’s identity with their likelihood of having HIV,” said Sarah Warbelow of the Human Rights Campaign, a group of LGBTQ advocacy.
The United States and several other countries began blocking blood donations from gay and bisexual men during the AIDS epidemic of the early 1980s, with the goal of preventing the spread of HIV through the blood supply.
In 2015, the FDA dropped the lifetime ban and replaced it with a one-year abstinence requirement. Then, in 2020, the agency cut the withdrawal period to three months after donations plummeted during the COVID-19 pandemic.
Regulators said there was no negative impact on blood supply as a result of those changes.
FDA sets requirements and procedures for blood banks in the U.S. All potential donors answer questions about their sexual history, injection drug use, and any recent tattoos or piercings, among other factors that may contribute to spread of blood-borne infections. The donated blood is then tested for HIV, hepatitis C, syphilis and other infectious diseases.
Under the new proposal, men who have sex with men will be asked if they have had new or multiple partners in the past three months. Those who answered yes to both questions and also reported having 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.
Anyone who has ever tested positive for HIV would still be ineligible to donate blood. Even those taking pills to prevent HIV would still be excluded, up to three months after their last dose. The FDA noted that the drug, known as PrEP, may delay detection of the virus in screening tests.
Marks said the agency was willing to consider further easing of restrictions “but we need to have the science to do that.”
FDA regulators will take public comments on the proposal for 60 days before starting to finalize the guidelines.
The proposed policy mirrors those used in Canada and the United Kingdom
The FDA based its latest proposal, in part, on a recent study of 1,600 gay and bisexual men. FDA-funded research compared the effectiveness of a detailed, personalized sexual behavior questionnaire with 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 will require new questionnaires, staff training and computer software upgrades.
The Red Cross said it supported the FDA’s changes but added it was too early to know if they would result in more blood donations.
Lukas Pietrzak of Washington DC, said he eagerly 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 became ineligible after becoming sexually active as a gay man.
“Until I fully hung out with my friends, I had to work around why I never went to blood drives with them,” says Pietrzak, 26, who now works for the federal government.
When there are calls for blood donations “we are now able to be part of them,” Pietrzak said.