FDA eases blood donation policy regarding gay and bisexual men
The Food and Drug Administration finalized recommendations making it less restrictive for gay and bisexual men to donate blood.
The agency said in a news release that blood donor eligibility will now be determined using a set of "individual, risk-based questions to reduce the risk of transfusion-transmitted HIV."
The recommendations, first proposed in January, ask that all donors answer individual risk assessment questions to screen for possible HIV exposure.
Previously, guidelines required a three-month abstinence period for donations from men who have sex with men, a restriction that was opposed by gay rights groups and medical societies including the American Medical Association. That blanket rule is being eliminated.
"The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community," said Peter Marks, M.D., PhD., director of the FDA's Center for Biologics Evaluation and Research, in a news release announcing the finalization of the recommendations.
People taking pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), medications that can reduce an individual's chance of developing HIV, will still have a waiting period based on their most recent dose of the medication, because use of those medications can lead to possible false-negative results in HIV screening blood tests. People engaging in other behaviors considered risky, including injection drug use and sex work, will also still have a deferral period. Donors who report new sexual partners or multiple sexual partners in the past three months, and also report having had anal sex in the past three months will still be recommended to have a deferral period.
The goal of the new guidelines is to expand the number of people eligible to donate blood while still "maintaining the appropriate safeguards" to keep the supply of donor blood safe, the agency said. The FDA added that the new policy is based on "the best available scientific evidence," and mirrors policies in peer countries like the United Kingdom and Canada.
"The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place," Marks added.
Editor's note: A line in this story was updated to clarify certain donors will face a recommended deferral period.