WASHINGTON D.C. — (12-16-20) — The Food and Drug Administration (FDA) has announced it will be funding a study around blood donations by gay and bisexual men.
On Tuesday, the FDA announced that the study titled, “Assessing Donor Variability and New Concepts in Eligibility (ADVANCE)”, has begun. According to the FDA, the study aims to evaluate whether donor deferral criteria can be based on individual risks assessment. The study also aims to present data to the FDA by the fall season of 2021.
Assessing Donor Variability and New Concepts in Eligibility (ADVANCE)
The ‘Assessing Donor Variability and New Concepts in Eligibility’ study could lead to the removal of restrictions around donations by gay and bisexual men.
“The FDA remains committed to considering alternatives to time-based deferral by generating the scientific evidence that is intended to support an individual risk assessment-based blood donor questionnaire,” the agency said in a statement released to JRL CHARTS.
The ADVANCE study will evaluate 2,000 men who identify as gay or bisexual that want to donate blood. Many feel that the results of the study could generate data to help the FDA decide if a questionnaire based on individual risk assessments is as effective for reducing the risk of HIV.
The FDA loosened restrictions on gay men donating blood in April after the coronavirus pandemic caused a blood shortage. The agency recommended a three-month deferral for gay men as opposed to the their long held standard of a full-year ban.
The FDA restrictions on Gay and Bisexual men stem from the AIDS crisis in the 1980s, but many nations have rolled their restrictions back.
Article by: Paul Goldberg, Staff Writer
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