On May 11, the United States Food and Drug Administration (FDA) announced new regulations on blood donation that pave the way for more bisexual and gay men to donate blood. The regulatory agency finalized a new set of risk-based rules for blood donation. Prospective donors will be asked the same set of questions during donor screening regardless of their sexual orientation or sex going forward.
The new rules move the US away from a restrictive and outdated policy that only applied to men who have sex with men (MSM) and women who have sex with MSM. According to the FDA, the updated policy is “based on the best available scientific evidence” and is more in line with policies already in place in the United Kingdom and Canada. It will also potentially expand the number of eligible blood donors, while maintaining safeguards put in place to protect the blood supply.
“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, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “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.”
Over the last several years, the FDA has begun to consider easing the blood donation rules for gay and bisexual men, who in past years faced a lifetime ban on blood donation. Many scientists and LGBTQIA+ organizations say this policy was discriminatory and based on outdated stigmas.
The FDA dropped the lifetime ban on donations from MSM in 2015 and replaced it with a one-year abstinence requirement. In 2020, the regulatory agency shortened that abstinence period to three months, after blood donations plummeted due to the COVID-19 pandemic.
The FDA’s most recent proposed draft recommendations were published in January 2023 and first proposed in late 2022. It required MSM and women who have sex with MSM to wait three months after sexual contact with other men before donating blood. Ahead of these draft-recommendations, Sarah Kate Ellis, President and CEO of LGBTQ advocacy organization GLAAD called the FDA’s proposal an, “important step, our community and leading medical experts will not stop advocating for the FDA to lift all restrictions against qualified LGBTQ blood donor candidates.”
The changes announced today eliminate screening questions and time deferrals specific to MSM and women who have sex with MSM.
Additionally, the new questions are designed to reduce the risk of transmission of human immunodeficiency virus (HIV) through blood donation. The FDA says that it reviewed data available from other countries with similar rates of HIV. The agency has already implemented risk-based eligibility for blood donations, HIV surveillance, and accurate virus testing for safety.
According to the FDA, those taking medications to treat or prevent HIV like antiretroviral therapy and PrEP will be deferred from donation. The agency says that while HIV is not transmitted during sex in people whose viral levels are undetectable, this does not apply to blood donation. This is because blood is transfused directly into a vein during a transfusion which involves a larger volume of fluid, so it is inherently riskier than sexual contact. They did not advise stopping either PrEP or other HIV medications in order to donate blood.
To reduce the likelihood that someone with a new or undetected HIV infection, anyone who reports a new sexual partner, more than one sexual partner, or recent anal sex will be told to wait at least three months before donating blood with these new rules.