FDA loosens restrictions on blood donations for gay, bisexual men

Key takeaways:

• The finalized policy proposal aligns with those of countries like the United Kingdom and Canada.
• All potential donors will be asked a series of risk-based questions to reduce the likelihood of HIV transmission.

The FDA has finalized its recommendations for blood donation, which will change time-based deferrals for men who have sex with men to individual risk-based questions to reduce the potential risk for HIV transmission.

The agency first proposed to ease restrictions on blood donation for gay and bisexual men in late January.

“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community.”

Under the previous policy, men who have sex with men (MSM) and women who have sex with MSM were given time-based deferrals if they wanted to donate blood. Now, all potential donors will be asked a series of individual, risk-based questions. Those who report having had a new sexual partner, or more than one sexual partner in the last 3 months, and anal sex in the past 3 months  will be deferred. Potential donors who are taking medications to prevent HIV will also be deferred. This is because antiretroviral drugs are effective and may delay detection of HIV. People should not stop taking their prescribed medications in order to donate blood, the agency stressed.

Meanwhile, expanding the number of potential blood donors has become vital amid a struggling blood supply throughout the United States. Last year, the American Red Cross declared a national blood crisis for the first time.

Moving forward, 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 said.

References:

• FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations. https://www.fda.gov/news-events/press-announcements/fda-finalizes-move-recommend-individual-risk-assessment-determine-eligibility-blood-donations. Published May 11, 2023. Accessed May 11, 2023.
• FDA proposes individual risk assessment for blood donations, while continuing to safeguard U.S. blood supply. https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply. Published Jan. 27, 2023. Accessed May 11, 2023.