FDA finalizes blood-donation rules to allow more gay, bisexual men
WASHINGTON - Gay and bisexual men in monogamous relationships can donate blood in the U.S. without abstaining from sex, under a federal policy finalized Thursday by health regulators.
The Food and Drug Administration guidelines ease decades-old restrictions designed to protect the blood supply from HIV. The agency announced plans for the change in January and said this week the new approach can now be implemented by blood banks.
The updated guidelines do away with a requirement that men who have sex with men abstain from sex for three months prior to giving blood.
Instead, all potential donors — regardless of sexual orientation, sex or gender — will be screened with a new questionnaire that evaluates their individual risks for HIV based on sexual behavior, recent partners and other factors. Potential donors who report having anal sex with new partners in the last three months will be barred from giving until a later date.
The FDA said the new policy reflects the latest scientific evidence and is in line with rules in the U.K. and Canada.
It’s the latest move by the FDA to broaden donor eligibility, with the potential to boost donations.
"The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community," Dr. Peter Marks, director of the FDA's center for biological therapies, said in a statement.
Gay rights groups have long opposed blanket restrictions on who can give blood, saying they discriminate. Medical societies including the American Medical Association have also said such exclusions are unnecessary given advances in blood testing.
Anyone who has ever tested positive for HIV will continue to be ineligible to donate blood. Those taking pills to prevent HIV through sexual contact will also still be barred, until three months after their last dose. The FDA noted that the medications, known as PrEP, can delay the detection of the virus in screening tests.
The FDA sets requirements and procedures for U.S. blood banks. All potential donors answer questions about their sexual history, injectable drug use and any recent tattoos or piercings, among other factors that can contribute to the spread of blood-borne infections. Donated blood is then tested for HIV, hepatitis C, syphilis and other infectious diseases.
In 2015, the FDA dropped the lifetime ban on donations from men who have sex with men and replaced it with a one-year abstinence requirement. Then in 2020, the agency shortened the abstinence period to three months, after donations plummeted during the COVID-19 pandemic.
Regulators said there has been no negative impact on the blood supply as a result of those changes.