The U.S. Food and Drug Administration (FDA) on Tuesday released draft guidance floating the idea of moving forward with implementing a one-year deferral period for men who have sex with men (MSM) when it comes to donating blood and other biological products.

Under the current policy, first adopted in 1983 at the height of the AIDS epidemic, men who have engaged in sexual activity with another man — even once — since 1977 have been “indefinitely deferred” from donating blood, essentially constituting a lifetime ban for MSM who wish to donate. But several in the medical community have argued that the lifetime deferral policy is medically and scientifically unwarranted.

As far back as 2006, organizations involved with blood donations, such as the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks, have recommended a change from lifetime deferral to a 12-month window following the last sexual contact. In November 2014, the federal Advisory Committee on Blood and Tissue Safety Availability, which advises the Secretary of the Department of Health and Human Services, recommended switching over to the 12-month deferral period by a 16-2 vote. In December, the FDA’s Blood Products Advisory Committee held an open public hearing on the topic, with some committee members expressing support for a one-year deferral period. The committee failed to issue a final recommendation. 

The draft guidance, which has been released and posted to the FDA website as part of a 30-day period of public comment, is non-binding and does not create or confer any rights for any particular group. Any recommendations made still have yet to be finalized before any change in practice can go into effect. Comments will be accepted both online at regulations.gov and in writing to the FDA’s Division of Dockets Management in Rockville, Md. 

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Under the proposed recommendations,  MSM who are abstinent one year after their last sexual encounter would be cleared to donate blood or organ tissue, essentially putting them on the same plane as heterosexuals who engage in high-risk behaviors. The one-year deferral period would be applied to the following groups:

• Anyone, regardless of sexual orientation, who has had sexual contact with another person who is HIV-positive, has ever exchanged sex for money or drugs, or engaged in non-prescription injection drug use
• Anyone who has received a blood transfusion in the past 12 months
• Anyone who has a history of contact with the blood of another individual, such as a medical provider who was exposed via a needle stick or contact with an open wound
• Anyone who has received a tattoo, ear or body piercing in the last 12 months, or has a history of tattoo, ear or body piercing — unless the tattoo was applied by a state-regulated entity with sterile needle and non-reused ink or the piercing was done using single-use equipment
• Anyone who has previously been treated for syphilis or gonorrhea
• Men who have had sex with men
• Females who have had sex with a man who has had sex with men

Indefinite referrals would still remain in place for HIV-positive people, those who have directly engaged in sex for money or drugs, or non-prescription IV drug users. 

The draft guidance also recommends that potential donors be provided updated educational material warning them of the risk of HIV transmission via blood and blood products, behaviors that would put one at risk of HIV infection, and signs and symptoms associated with HIV infection, in the hopes that people who have engaged in risky behaviors will self-defer. Other recommendations include the use of an updated donor history questionnaire to assess potential donors based on self-reporting of the major categories of people at heightened risk of HIV. For transgender individuals, one’s gender is self-identified and self-reported on the form, but medical directors may exercise their own discretion, based on responses to the donor history questionnaire, as to whether the individual should be eligible to donate blood or tissue.

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Some LGBT allies and advocates expressed optimism that the policy is slowly moving in the right direction. U.S. Senator Patty Murray (D-Wash.), the ranking member of the Senate Health, Education, Labor, and Pensions committee and the fourth-highest ranking Democrat in the U.S. Senate was “pleased” that the FDA was moving to revise the ban but “disappointed” that the guidance continues to discriminate against some health gay and bisexual men.

“Healthy Americans, regardless of their sexual orientation, should have the opportunity to donate blood and help in the effort to save lives,” Murray said. “I look forward to working with the FDA to build on these steps to remove discriminatory policies while keeping our blood supply safe.”

The American Civil Liberties Union (ACLU) was much less rosy in its assessment, pointing out, as it had when the deferral period was first floated in November of last year, that the recommended deferral would continue to function as a de facto lifetime ban, even in the case of a monogamous same-sex couple that has been in a committed relationship for years. 

“As the ACLU made clear late last year, this inadequate proposal must be seen as part of an ongoing process and not an end point,” said Ian Thompson, legislative representative for the ACLU. “Deferral decisions should be based on activities presenting an elevated risk, not on the identity of a person or that person’s partner. The reality for the vast majority of gay and bisexual men is that this policy continues to stigmatize their intimate relationships and will indefinitely bar them from donating. In addition, this proposal leaves open the possibility that transgender individuals will continue to be needlessly barred from being able to donate.”

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The Human Rights Campaign (HRC), the nation’s largest LGBT civil rights organization, also responded to the FDA’s recommendations, calling the proposed policy “unacceptable.”

“While the new policy is a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men,” said David Stacy, HRC’s government affairs director. “This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply. It simply cannot be justified in light of current scientific research and updated blood screening technology. We are committed to working towards an eventual outcome that both minimizes risk to the blood supply and treats gay and bisexual men with the respect they deserve.”