Gay and bisexual men may soon be allowed to donate blood without a fixed period of sexual abstinence, the federal Food and Drug Administration announced late last month in response to a Wall Street Journal report about the policy change. Instead, the revised policy would be based on individual risk assessment.
"The FDA remains committed to gathering the scientific data related to alternative donor deferral policies that maintain a high level of blood safety," the FDA said in a November 28 statement. The agency added that it anticipates "issuing updated draft guidance in the coming months."
The FDA, the American Red Cross, two other large nonprofit blood centers, and several LGBTQ community centers have been working together to assess potential alternative eligibility requirements in the ADVANCE (Assessing Donor Variability and New Concepts in Eligibility) study. The Bay Area Reporter previously reported on the study in January.
LGBTQ advocates, many medical professionals, and progressive legislators have argued that blood donation exclusions should be based on behavioral risk, not identity. The American Red Cross, American Public Health Association, and American Medical Association all support risk-based rather than identity-based policies. The Red Cross "believes blood donation eligibility should not be determined by methods that are based upon sexual orientation," the agency stated.
"While today's reports of an overdue move from the FDA is 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," Sarah Kate Ellis, president and CEO of GLAAD, stated in a news release responding to the new developments.
Incremental changes
Gay and bisexual men were first prohibited from donating blood in the mid-1980s in an effort to curb HIV transmission. Initially, any man who had had sex with another man since 1977 — roughly when HIV was thought to have begun circulating in the United States — was banned from donating for life.
The controversial policy has been loosened over the years as blood screening technology has improved and advances in antiretroviral treatment and PrEP have enabled HIV-positive people to maintain an undetectable viral load and HIV-negative people to dramatically reduce their risk of acquiring the virus.
In 2015, the FDA's Center for Biologics Evaluation and Research said that men who have sex with men could donate blood if they had not had sex for one year. The current policy — adopted in April 2020 as the COVID-19 pandemic led to a severe blood shortage — reduces the waiting period to three months. The same deferral period applies to women who have sex with gay or bi men, sex workers, people who inject drugs, people who recently received tattoos or piercings, and those who recently traveled to certain countries.
Modern nucleic acid testing can reliably detect HIV and other blood-borne pathogens by three months after infection, but it is not quite as sensitive during the early part of that window. Despite current restrictions, and testing approximately 12 million units of donated blood annually, 10 units containing HIV have slipped through, according to the Human Rights Campaign.
The proposed policy revision would move away from blanket deferral periods for specific groups and would instead assess individual risk behavior using questionnaires. For example, a gay man who has had no new recent sex partners would potentially be allowed to donate, the Wall Street Journal reported, citing unnamed people familiar with the plan.
The United Kingdom moved to a risk-based policy in 2020, allowing gay men in monogamous relationships to donate blood. Canada's risk assessment strategy, adopted in September, asks uniform questions about sexual activity, medical history, and travel regardless of gender or sexual orientation. Several European, Central and South American, and Asian countries do not restrict blood donation by gay or bi men.
"Policies and protocols which focus on targeted screening for specific high-risk behaviors, regardless of sexual orientation, are a much more scientifically rigorous and non-discriminatory approach to maintaining a safe blood supply," Dr. Deborah Cohen and Dr. Monica Hahn of UCSF wrote in an open letter to the FDA in response to the 2020 policy revision, which was signed by more than 500 clinicians, public health professionals, and researchers.
Some advocates think the FDA's latest proposed changes do not go far enough.
"Giving one set of rules to some people, and another set of rules to others, based purely on identity, is blatant discrimination," stated GLAAD's Ellis. "This fight is not over until all LGBTQ Americans who want to donate blood are met with the same protocols as other Americans. All potential blood donors, whose donations could save lives, should be treated equally. There is no excuse for choosing stigma over science in 2022."
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