The United States Food and Drug Administration released a draft of new blood donation guidance Friday that would allow gay and bisexual men in sexually monogamous relationships to donate blood - but not if they are on PrEP. The news, made during National Blood Donor Month, comes as health officials across the country warn there is a critical need for blood donations.
The agency's hardline ban on men who have sex with men from donating blood has crumbled in recent years. The initial rule, promulgated in 1983 during the early days of the AIDS epidemic, was a lifetime ban on any man who had sex with another man after 1977. This was changed in 2016 to a 12-month deferral, and again in 2020 to a three-month deferral.
Technology to screen blood samples for HIV, the virus that causes AIDS, has rendered a blanket ban obsolete, according to the American Medical Association. LGBTQ rights groups have long argued that any ban should be based on reported behaviors, not sexual orientation.
People who are HIV-negative but taking pre-exposure prophylaxis (PrEP) will still be banned from donating blood under the draft guidance, however, because the medications used for PrEP are among those that can't be taken by blood donors.
"We feel confident that the safety of the blood supply will be maintained," the FDA's Dr. Peter Marks told the Associated Press.
Gay Assemblymember Evan Low (D-San Jose) told the Bay Area Reporter he welcomed the updated policy. The California lawmaker has long pushed to see the nation's policies restricting gay and bisexual men from being blood donors be updated.
"Countless opportunities to save and preserve lives are lost every day with this discriminatory ban in place. It's about time," he wrote in a text message.
Carl Schmid, the executive director of the HIV+ Hepatitis Policy Institute, called the draft guidance a "monumental shift."
"No longer will eligibility to donate blood be based on sexual orientation," Schmid stated. "Instead, every person, no matter their sexuality, will be reviewed individually in order to determine their eligibility to donate. 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."
Schmid stated that when the FDA under former President Donald Trump reduced the ban to three months, "it still applied to all gay men."
"Today's draft guidance removes the restrictions based on sexual orientation and moves it to sexual activity," Schmid continued. "Under the proposal, all blood donors will be screened for HIV risk in the same way, with restrictions on donation based on sexual and other practices over the three months prior to the donation. This should enlarge the pool of blood donors at a time of historic shortages in the nation's blood supply while continuing to ensure its safety."
The guidelines are not yet official policy - the public will have a 60-day period for comment. In announcing its decision the FDA noted the proposed individual risk-based questions are in line with policies in place in countries like the United Kingdom and Canada.
"Whether it's for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day," stated FDA Commissioner Dr. Robert M. Califf. "Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so."
The Human Rights Campaign tentatively praised the new policy proposal, while lamenting that those who take PrEP can't participate.
"This new policy removes a decades-long barrier for many in our community - and there is more to do to ensure gay, bisexual, and transgender people are no longer unfairly stigmatized when they try to donate blood," HRC President Kelley Robinson stated. "The assessment criteria have flaws, focusing excessively, for instance, on the number of partners a potential donor has instead of just on new partners. It is also unfortunate that the new policy continues to ban those on PrEP from donating blood. PrEP is the most powerful weapon we have to protect individuals from contracting HIV and to eventually wipe out the disease entirely."
Robinson conceded that while being on PrEP can conceal an HIV-positive status, "there is a solution on the horizon thanks to technologies being developed that would inactivate pathogens in the blood.
"In the meantime, it is absolutely essential that those who are currently receiving PrEP treatments continue to remain with their medication. We will soon be a step closer to ending the stigma that has existed for decades as a result of the harmful blood donation ban, and in the process, we will be able to ensure that the blood supply remains protected. Now the work must continue to refine this policy," Robinson concluded.
Gay state Senator Scott Wiener (D-San Francisco) was also critical of the ban on people taking PrEP from donating blood. In a tweet he noted that if they wanted to donate, people on PrEP would have to go off the regimen for three months, increasing their risk of contracting HIV.
FDA says it's ending ban on gay men donating blood.
But FDA continues to ban anyone on PrEP from donating - a huge # of gay men. So if you take PrEP - ie, very low HIV risk - you're banned.
FDA's solution if you want to donate: Stop taking PrEP for 3 months & > your HIV risk.🤯
- Senator Scott Wiener (@Scott_Wiener) January 30, 2023
Blood donations are in critically short supply across the U.S. On Thursday, health officials in Washington state sounded an alarm about the need for more, and new, blood donors in the Northwest.
"New blood donors are needed every day to replace those who can no longer donate," stated Jennifer Hawkins, regional director for Vitalant Northwest, a division of the national nonprofit focused on blood donation. "However, blood centers are seeing fewer people step forward to roll up their sleeves. This is a perfect time to donate and continue donating three times a year. If everyone did this, we would no longer have emergency blood shortages across the Pacific Northwest."
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