New Blood Donation Rules to Loosen Restrictions on Gay and Bisexual Men
The Food and Drug Administration plans to revise a longstanding 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 on Friday.
The move follows years of criticism from L.G.B.T.Q. 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 H.I.V. 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 F.D.A. 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 F.D.A. 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 gender-inclusive — 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 H.I.V. or who has taken medication to treat an H.I.V. infection will be prohibited from donating, said Dr. Peter Marks, director of the agency’s biologics center.
People taking oral PrEP, to prevent H.I.V. 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 H.I.V. infection in donors taking the drugs, Dr. Marks said. People receiving injectable PrEP will be barred for two years after their last dose.
“Importantly, this approach will not change the testing policies and procedures that are required of blood establishments,” which will still screen all blood donations for H.I.V. and hepatitis C and other conditions, Dr. Marks said.
The change will ease a longstanding form of discrimination against L.G.B.T.Q. people, Sarah Kate Ellis, president of GLAAD, an advocacy group, said in a statement.
“These changes are 40-plus years in the making and are a tremendous leap forward toward elevating science over stigma,” Ms. Ellis said. The changes open “the door for all eligible L.G.B.T.Q. people to give blood and save lives.”
The Human Rights Campaign applauded the changes, but said they could be even better tailored to reduce risk to the blood supply and enable more people to give blood. The group said the F.D.A. should focus on data regarding the actual risk to the blood supply posed by people on PrEP medications.
Kelley Robinson, president of the Human Rights Campaign, said in a statement, “This proposed blood donation policy moves the country toward what L.G.B.T.Q.+ advocates and medical experts have been saying for years — that a science-based, individualized risk assessment is the best, most equitable way to ensure safety of the blood supply while reducing unnecessary discrimination against gay, bisexual and other men who have sex with men.”
A spokesman for Vitalant, a nonprofit blood donation organization, said it worked with the F.D.A. on a study that was central to gathering safety data on the new approach.
“It’s important to note that this change cannot happen overnight,” Nick Gehrig, the spokesman, said in a statement. “Once final, it will take time to update the donor history questionnaire and our computer systems and train our staff, which we intend to complete as quickly as possible.”
The F.D.A. said it would open the current proposal for a 60-day comment period. The agency will review and adjust the proposed policies based on input from various parties, and it will put the new strategy in place as soon as possible, officials said.