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FDA likely to change blood donor policy for gay, bisexual men

The Minnesota Department of Health is among the agencies that have criticized the current policy, calling it "ineffective, unnecessary and discriminatory."

MINNEAPOLIS — The Food and Drug Administration (FDA) said it's likely to support changes to its blood donation policy, thus allowing more gay and bisexual men to donate.

"As somebody who identifies as a gay man, I'm aware of the policy that I don't think many people realize is that most gay men cannot donate blood," said Christopher Johns, a fourth year medical student at the University of Minnesota. 

Starting in the 1980s during the HIV/AIDS epidemic, the FDA placed a lifetime ban on blood donations from men who have sex with men (MSM). The FDA changed the policy in 2015 to allow donations from MSM if they abstained from having sex for a year. In 2020 — with severe blood shortages during the pandemic — the FDA shortened the deferral period to three months. 

"Going into med school, I was aware of this policy but I didn't really understand the medicine behind it or why that was the case... why we were being barred from that. As I eventually learned more and began my studies, I really recognized there were some problems with the system and discovered that this wasn't necessarily medically sound," Johns said. 

Johns researches transfusion-related policies that target MSM. Through a survey, his research found that the shift from 12 months to 3 months did not increase participation in blood donations. But numbers dramatically went up in people willing to donate if they could do so immediately. 

"The thing that was interesting is that the majority of people who were surveyed who did donate blood, did so against deferral guidelines. Meaning that... within that deferral period, they had sex. Which shows that these guidelines aren't actually stopping a lot of these men from donating blood," Johns said. 

In a statement to KARE 11, the FDA said it is "committed to evaluating alternatives to the time-based deferral policy by helping to facilitate the generation of the scientific evidence that might support an individual risk assessment-based blood donor questionnaire."

The FDA is currently reviewing results from the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) pilot study. Although they do not have a timeline of when their analysis will be complete, "the agency believes the initial data from the study, taken in the context of other data available from blood surveillance in the U.S. and in other countries, will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of HIV transmission."

In March 2022, the Minnesota Department of Health joined other public health agencies in signing on to a letter addressed to the FDA commissioner. The letter included concern for the nationwide blood shortage and called for the FDA to remove it's 90-day blood donor referral policy for MSM. 

The letter stated, "There is no credible evidence that the 90-day MSM blood donation deferral period improves the safety of the nation's blood donation supply" and called the current policy "ineffective, unnecessary, and discriminatory." 

The American Red Cross said it "looks forward to learning more and remains committed to working toward an inclusive and equitable blood donation process that treats all potential donors with equality and respect, and ensures a safe, sufficient blood supply is readily available for patients in need."

For safety reasons, donated blood already gets tested for infectious diseases. 

"It does point to a bigger question... is it actually ethical, these deferral policies? Especially when you look at certain populations of gay men, such as those who are in monogamous relationships or those who are using medication to prevent STDs and STIs, that these donor people are concerned with," Johns said. 

The FDA said it anticipates issuing updated draft guidance in the coming months 

Johns said, "As a gay man, myself, I'm really excited for there to be a time when I'm able to actually donate." 

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