US FDA Drops Restrictions on Blood Donation by Gay and Bisexual Men

On May 11, 2023, the US Food and Drug Administration (FDA) officially lifted restrictions on blood donation by gay and bisexual men. The ban was put in place in 1983 during the early days of the AIDS epidemic to ensure the safety of the blood supply. However, over the years, medical professionals and gay rights advocates argued that the ban was no longer medically justifiable and unnecessarily discriminated against men who have sex with men.

Changes in Science and Protocols

Since the ban was implemented, scientific advancements and strict protocols have nearly eliminated HIV transmission through blood. The last documented transmission of HIV through a US donor’s blood product occurred almost 15 years ago. In addition, the US government implemented a nationwide system in 2013 to monitor the safety of the US blood supply for different pathogens, including HIV. Given this progress, many medical experts believe that the benefits of the ban no longer outweigh the hit to the blood supply or the harm caused by a discriminatory rule.

New Guidelines for Blood Donation

The FDA has been working towards revising the ban since 2015. In December of that year, men who have sex with men were allowed to donate blood if they had not had sexual contact for one year. The period was further reduced to three months in April 2020 to help fight a critical blood shortage during the COVID-19 pandemic. However, these updates did not change the FDA’s assessment that men who have sex with men are high-risk donors.

Under the new guidelines, blood donor history questionnaires will be used to evaluate an individual’s risk rather than relying on broad categorizations. The guidelines differentiate between individuals who are monogamous and those who are not, as well as between those who have not engaged in anal sex in the prior three months and those who have. If an individual is assessed to be high-risk, the guidelines recommend preventing them from donating blood for three months.

This shift represents a seismic change for men who have sex with men and the critically low US blood supply. Research suggests that lifting the ban will lead to a 2% to 4% increase in the blood supply, potentially saving over a million lives. Removing gender and sexual orientation from the risk assessment for blood donation will also help address stigma and discrimination against men who have sex with men.