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The FDA is planning to ease rules that for decades have barred or discouraged men who have sex with men (MSM) from donating blood, due to concerns over HIV transmission.

In released on Friday, the agency recommended moving toward "gender-inclusive individual risk-based questions" as a means of mitigating the risk of transfusion-transmitted HIV. The approach would mean that MSM could donate blood if they meet eligibility criteria, such as being in a monogamous relationship.

The agency takes the responsibility of maintaining a safe blood supply seriously, said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, during a press call. "Today's draft recommendations provide an opportunity to expand donor eligibility, while still upholding these responsibilities and minimizing the risk of transmitting infectious diseases."

He called the proposed changes a "significant step forward," noting that this new approach would be "as inclusive as it can be" in light of the available science.

"This marks a monumental shift and ends a long and painful era of blanket discrimination against gay men. No longer will eligibility to donate blood be based on sexual orientation," Carl Schmid, executive director of the HIV+ Hepatitis Policy Institute, said in a statement following the news.

"Instead, every person, no matter their sexuality, will be reviewed individually in order to determine their eligibility to donate," continued Schmid. "While this long-overdue change is being made based on the science and the facts, which have been clear for years, it is the result of the leadership of the Biden administration that continues to tear down discriminatory government policies."

Under past rules initiated in 2015, the FDA allowed blood donations by MSM if they abstained from sex for 12 months first (this was then reduced to 3 months starting in April 2020).

Marks explained that the proposed guidance recommends changing the current donor history questionnaire in such a way that all prospective donors of any gender are asked whether they had "new or multiple sexual partners in the past 3 months." Those who report having had a new partner or more than one partner in this time frame would also be asked to provide a history of anal sex in the past 3 months.

"All prospective donors, regardless of their gender identification, who report having a new partner or more than one partner and anal sex in the past 3 months would be deferred from donation," he said.

Upon questioning, Marks clarified that a person who has had vaginal sex with a new partner in the last 3 months would be eligible to donate blood, but a person who has had anal sex with a new partner in the last 3 months would not, given that anal sex is linked to "a higher risk of exchange of blood."

Those who have ever tested positive for HIV, or who have taken medication to treat HIV infection, would continue to be "deferred permanently," he noted.

In addition, those taking oral pre-exposure prophylaxis (PrEP) would be deferred for 3 months from their most recent dose, while those receiving injectable PrEP would be deferred for 2 years from their last injection, he continued.

These recommendations stem from "available data demonstrating ... delayed detection of HIV by licensed screening tests for blood donations" related to these medications, which can potentially lead to false-negative results, Marks explained.

Among people taking PrEP, there still exists a risk of contracting HIV, of about 1 in 100 person-years or 0.5 in 100 person-years, depending on the regimen, he added. "So, until we can better sort out who is of lower risk in that group taking PrEP, we need to put this donor deferral in place."

The FDA will continue to track data related to PrEP and blood donation, he said, and this may not be the agency's "final resting place" when it comes to donor eligibility.

Another proposed change focused on people who were previously deferred indefinitely for exchanging sex for money or drugs and those with a history of non-prescription injection drug use, who may now be eligible to donate, "provided the donor meets all donor eligibility criteria."

FDA Commissioner Robert Califf, MD, noted that "donating blood is one of several really important symbolic methods of demonstrating one's caring for other people. So, we want to make that available to everyone possible in the context of a safe blood supply."

The proposed changes are based on multiple data sources, including data from the U.K. and Canada, which have implemented similar policies for donor eligibility; a review of surveillance information from the Transfusion-Transmissible Infections Monitoring System; "performance characteristics of nucleic acid testing for HIV"; and data from the Assessing Donor Variability and New Concepts in Eligibility Study (ADVANCE), according to an .

The ADVANCE study -- which is analyzing different HIV risk factors, such as anal sex -- found "a significant fraction of men who have sex with only one partner who should be able to donate," Marks said, noting that results of the study are expected to be released "over the coming months."

Once final guidance is issued, establishments collecting blood or blood components should update their donor educational materials, donor history questionnaires, and other accompanying materials, the FDA noted, and should revise "donor requalification and product management procedures."

Furthermore, the new guidance "will supersede the guidance entitled, 'Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products' dated April 2020, updated August 2020," the agency wrote.

The draft guidance will be open for comment for 60 days.

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