FDA releases draft guidelines on expanded LGBTQ+ blood donor eligibility

Avanti Khare, Sci-Tech Editor

The U.S. Food and Drug Administration announced on January 27, 2023 that it would be drafting recommendations toward assessing blood donor eligibility using gender-inclusive, individual risk-based questions to limit the spread of transfusion-transmitted human immunodeficiency virus (HIV), according to a press release on the FDA website. These draft recommendations are based on careful review of available information, including data from other countries with similar HIV epidemiology as well as ongoing surveillance of the U.S. blood supply. Based on the available data, the agency believes the implementation of the proposed guidelines will not compromise the safety or availability of the blood supply.

Katie Boermeester ‘24 is the current president of Union Pride. She had this to say about the policy change: “It might not seem like much to most, but the rephrasing and adding of various gender- and sexuality-inclusive policies and guidelines for blood donors is a big step. Not only does this change help destigmatize and promote the idea that people within the LGBTQIA+ community are not all stricken with HIV, AIDs, and other sexually-transmitted diseases, but it also allows eligible donors that are members of our community to donate and help give back.” She also added that “more work needs to be done in terms of destigmatizing and disproving the idea that members of our community are carriers of earlier-said diseases.”

Under the new proposal guidance, the current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners. This procedure will replace the time-based deferrals for blood donation previously placed on men who have sex with men (MSM) and women who have sex with MSM. Prospective donors who report having a new sexual partner or more than one sexual partner in the last three months, would then be asked about a history of anal sex. Under the new guidance, all prospective donors who report having a new sexual partner or more than one sexual partner in the past three months and reported having anal sex would be deferred from donation eligibility. This guidance affects donor eligibility of MSM in monogamous relationships, as they will continue to be deferred as long as they report sexual contact with another man in the last three months, according to the American Red Cross LGBTQ+ Donor Information Page.

The new guidance does not include changes to the FDA’s policy for donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use. Blood establishments are still required to test all blood donations for evidence of certain transfusion-transmitted infections, such as HIV, Hepatitis B, or Hepatitis C.

This proposal will be open for public comment for 60 days from the initial release date. The agency will then review and consider all comments before finalizing this guidance, which would then be implemented by all blood collection establishments.