Orlando LGBT center involved in study that could change FDA blood donation rule

Policy may shift to individual risk assessments in wake of new data

ORLANDO, Fla. – Changes could be coming to the Federal Drug and Administration policy involving blood donations from men who have sex with men (MSM).

“We had a lot of the LGBT community, particularly men who were unable to donate or barred from donating because of the FDA’s policy,” said John Harris Maurer, who was reflecting on the moments after the Pulse Nightclub shooting back in 2016.

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Maurer said that it hurt members of the LGBT community who wanted to donate blood but couldn’t due to concerns over potential HIV transmission.

This may now change after a research program was funded by the FDA.

“This is a ground-breaking study, and it’s a study we’ve been waiting to have,” said Susan Forbes, the Senior VP of Corporate Communications and Public Relations for OneBlood.

Forbes is referring to the ADVANCE Study. ADVANCE stands for Assessing Donor Variability And New Concepts in Eligibility.

Current federal guidelines state that a gay or bisexual man must wait for three months before donating blood after their last sexual contact.

“What this is now looking at is: could we move away from a time-based deferral of three months and move to an individual risk assessment? So that is what the FDA is looking at, and that is what the ADVANCE Study is about,” Forbes said.

Forbes told News 6 that the two year program wrapped this past September and explained OneBlood was one of the blood centers to help enroll some of the 2,000 participants.

The blood center used places like the LGBT Center of Orlando for outreach.

Each person in the study had to fill out questionnaires before donating blood. This blood sample will be tested in a research laboratory for HIV, as well as for anti-retroviral drugs found in pre-exposure prophylaxis.

After a few weeks, according to the ADVANCE Study’s website, participants will be asked to return to the location where they enrolled to learn of their test results. Depending upon the test results, participants will be asked to complete an additional questionnaire.

The data is still being reviewed, but initial results led to a statement from the FDA, which said the agency “will likely support a policy transition to individual risk-based donor screening questions.”

“We know these changes are overdue, but they are a welcome development,” Maurer said.

University of Central Florida graduate and LGBT activist Caleb Trent echoed Maurer’s thoughts and said that hearing this news encouraged him to get involved.

“I haven’t really considered it because of what I heard about gay men donating blood... but it does give me more confidence to go out there and do a blood drive,” Trent said.

The FDA said it is set to release a draft guidance for blood centers in the coming months.

At this time, they are not releasing results, but do say during the screening policy they tested was gender neutral.

News 6 will make sure to provide updates once those results have been released.

Here is the full statement provided by the FDA:

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About the Author:

Brian Didlake joined the News 6 team as a reporter in March 2021.