FDA’s Ban on MSM Blood Donations
Frequently Asked Questions
Under the U.S. Food and Drug Administration’s (FDA) current policy, gay and bisexual men — referred to as men who have sex with men (MSM) in epidemiological literature — who have had sex in the past three months are “deferred” from donating blood. This includes MSM who are HIV-negative, consistently practice safer sex, who are on PrEP, or who are in a monogamous relationship with a partner who is not living with HIV. This policy also affects transgender people because the FDA uses the prospective donor’s gender assigned at birth for identification purposes, which means that transgender women who have sex with men are also deferred, but transgender men who have sex with men are not.
In 1983, at the onset of the HIV/AIDS epidemic, the FDA implemented the ban — which originally prohibited MSM from donating blood for life — to help prevent inadvertent transmission of HIV through blood transfusions and blood products such as platelets. At that time, HIV/AIDS was largely not understood by doctors, scientists, and the general public, and the technology and procedures used to test donated blood for HIV were extremely limited. In 2015, the FDA changed the lifetime ban to a 12-month deferral, meaning that a prospective male donor who did not have sex with another man for a year could donate blood. Given that most MSM are not celibate, this change was a de facto lifetime ban. In 2020, the FDA reduced the deferral from 12 to three months in response to blood shortages caused by the COVID-19 pandemic.
In the decades since the FDA implemented the ban, vast improvements have been made in technology that can test donated blood for communicable diseases. Nucleic Acid Amplification Testing (NAT) can detect HIV in a unit of blood within a nine- to 11-day window period of the donor becoming infected. When combined with best practices that screen prospective donors for high-risk behavior, regardless of sexual orientation, NAT renders the MSM blood ban scientifically obsolete and unnecessary.
The FDA requires blood donation organizations to screen potential donors for risk factors related to HIV and other infectious diseases. Most administer a Donor History Questionnaire (Questionnaire), which asks about a donor’s current health, medical history, blood donation history, sexual practices, drug use, and other behaviors. Donors deemed to be high risk based on responses to the Questionnaire are deferred from donating blood for varying periods of time into the future.
The Questionnaire does not ask whether prospective donors have engaged in specific high-risk practices, such as unprotected sex, sex with multiple partners, or sex with a partner whose HIV status was unknown to the prospective donor. This leads to deferrals that focus on donors’ identity rather than high-risk behavior.
Will lifting the lifetime MSM blood ban increase the risk of contracting HIV through blood transfusion?
A joint statement released in 2006 by the American Association of Blood Banks (AABB), the Red Cross, and America’s Blood Centers, characterized the MSM blood ban as “medically and scientifically unwarranted,” and urged the FDA to modify blood donation policies so that they are “comparable with criteria for other groups at increased risk of sexual transmission of transfusion transmitted infections.” In a statement released in June 2013, the American Medical Association (AMA) declared that “the lifetime ban on blood donation for men who have sex with men is discriminatory and not based on sound science.”
The ban supports a false perception that heterosexual people are at low risk for HIV infection, while allowing individuals who participate in high-risk behavior, but who do not identify as gay or bisexual, to donate blood. It also reduces the availability of blood across the country, especially during emergencies like the COVID-19 pandemic. A study by the UCLA School of Law’s Williams Institute found that fully repealing the ban could potentially unlock over a half million blood units per year from men who have sex with men.
Consequences also include strong opposition to blood drives at many colleges, which only serves to reduce the blood supply. For example, San Jose State University does not allow blood drives on campus because the ban violates the university’s nondiscrimination policies. It also reinforces negative stereotypes about gay and bisexual people, which is especially problematic because most blood donations occur at blood drives in workplaces or schools, where gay and bisexual donors may worry about employment or the social ramifications of not donating.
At least 20 countries have no deferral period for MSM blood donors, and many more deferrals than range from three months to one year. Spain and Italy have adopted deferral policies based on comprehensive assessments that ask all prospective donors, regardless of sexual orientation, specific questions about high-risk practices.
The FDA should update the Donor History Questionnaire so that all potential donors are screened for high-risk behavior, regardless of sexual orientation. Only prospective donors determined to be at high-risk should be subject to deferral periods.