New blood donation rules loosen restrictions on gay and bisexual men
The Food and Drug Administration plans to revise a long-standing policy that excluded most gay and bisexual men from blood donation, instead adopting an approach that will screen donors depending on their recent sexual activity, agency officials said Friday.
The move follows years of criticism from LGBTQ advocates, who have described the prohibition as unscientific and discriminatory.
Federal officials have long justified the exclusion of gay and bisexual men as a way to keep HIV out of the blood supply. A complete prohibition was put in place in the 1980s. In 2015, the agency allowed gay and bisexual men to donate if they had not had sexual contact with other men for the previous year.
The period was reduced to three months after severe blood shortages during the COVID-19 pandemic.
The FDA said the new guidelines would be more inclusive and were based on a review of a recent study and data from other countries, including Britain and Canada, that took similar approaches. The new draft policy is also intended to shore up U.S. blood stores, which dipped at the outset of the pandemic and remain low.
“Whether it's for someone involved in a car accident or an individual with a life-threatening illness, blood donation saves lives every day,” Dr. Robert Califf, the FDA commissioner, said on a call with reporters.
“We're committed to doing the best available science to inform and revise our policies to increase those eligible to donate blood and to maintain appropriate safeguards to protect the recipients of blood products.”
The agency said the approach would be genderinclusive — the screening would also apply to women who have sex with gay and bisexual men — and would focus on individual risk, not blanket prohibitions on groups. People seeking to donate blood will be asked about their recent sexual activity and partners, as well as injectable drug use.
Potential donors will be asked whether they have had new sexual partners, or more than one sexual partner, in the past three months. If so, they will also be asked whether they engaged in anal sex. If they report such activity, they will not be permitted to donate at that time.
People who do not report new or multiple partners along with anal sex will be permitted to donate.
In addition, anyone who
has tested positive for HIV or who has taken medication to treat an HIV infection will be prohibited from donating, said Dr. Peter Marks, director of the agency's biologics center.
People taking oral PrEP, to prevent HIV infection, will not be able to donate blood until three months after their last dose. The rationale is that blood centers may not be able to detect an HIV infection in donors taking the drugs, Marks said.