The U.S. Food and Drug Administration released Friday’s proposed guidance to reduce restrictions on blood donation by men who have had sex with women.
After a period of public comment, the change will be effective.
These restrictions on donating blood were put in place to protect the supply of HIV-infected blood. They date back to the early days after the AIDS epidemic. In the beginning, it was strictly prohibited for gay and bisexual men to donate blood. The FDA lifted the lifetime ban but kept some restrictions in place.
The current policy, last updated in 2020, allows men to donate blood to other men who have had sex with them for at least three months.
The proposed policy would remove the time-based restrictions for men who have sex (and their female partners), and instead screen potential donors based on a series questions that assess HIV risk. Any person taking medication to prevent or treat HIV, such as PrEP, will not be eligible.
Anal sex would be part of the risk assessment. Potential donors who have had anal sex within the past three months with a new partner or more than one partner will not be eligible for blood donation.
These changes address criticisms that the current policy is outdated and discriminatory, and also serve as an additional barrier to increasing the nation’s blood supply. Donated blood is routinely tested for HIV by blood banks.
“We are moving now towards an inclusive policy for donation of blood,” Dr. Peter Marks, who heads the Center for Biologics Evaluation and Research at FDA, stated during Friday’s briefing.
“We will continue working to ensure that we have policies which allow anyone who wishes to donate blood to do so within the limits of what science allows. This is to ensure that the blood supply does not become unsafe.”
FDA has used the results from a study with approximately 1,600 gay and bisexual men as a basis for the development of new guidance. These questions can be used to identify potential donors most likely to contract HIV.
The positive reaction from advocates, medical organizations and blood banks to the news was overwhelming.
Kate Fry, CEO America’s Blood Centers, says that the “blood community is very excited about these proposed changes.” “We have been advocating for a change to an individual risk assessment model for over a decade. This is a welcome development for blood centers all over the country.
She stressed the importance of screening all blood donors for HIV. Testing has greatly improved to ensure safety.
The American Medical Association, American Red Cross, and LGBTQ+ advocacy organizations have been pushing for changes to federal blood donation rules for many years.
Tony Morrison, spokesperson for GLAAD, said that these changes have been 40 years in the making. “They’re a huge leap forward in elevating scientific knowledge over stigma.”
GLAAD and other groups argue that the changes are not enough. Some of the restrictions remain unnecessary and stigmatizing, including the ban on donations from PrEP-treated HIV patients.
“When we stigmatize people who are proactive in their sexual health, it is because we limit and defer them. Morrison says that the misconception that PrEP users are promiscuous or at higher risk for HIV infection is false.
His group will continue lobbying the FDA for further restrictions to be eased.
Public comment will be allowed on the proposed changes to blood donation rules for 60 days. The FDA will then examine the comments and issue a final ruling, likely later in the year. Monogamous gay men may be able to donate blood again in 2023.
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