FDA drops blood donation restrictions specific to gay and bisexual men

(WASHINGTON) — The Food and Drug Administration has dropped all restrictions specific to gay and bisexual men donating blood, a move long anticipated by public health experts and gay rights activists.

The new guidance, first proposed in January and finalized Thursday, will not restrict donations based on someone’s sexual orientation or gender identity, and instead move towards an “individual risk-based” approach to reduce the risk of accidental HIV infection through the blood donation system.

The FDA originally banned donations from gay and bisexual men in the midst of the 1980s HIV/AIDS crisis. In recent years, the FDA relaxed these rules, but had not lifted them completely.

Now, the new blood donation risk assessment will be the same for every donor regardless of how they identify.

It’s a move that public health experts and advocates have long argued for. Advocates say the HIV crisis has changed significantly since the 1980s, undercutting the rationale for restrictions based on sexual orientation. For example, the HIV epidemic has spread far beyond gay and bisexual men, with women accounting for roughly 1 in 5 new HIV diagnoses in the United States, according to the most recent CDC data available.

Meanwhile, testing of the blood supply improved, dramatically reducing the risk of blood-borne transmission through the blood donation system.

“This change reflects advancements in molecular tests as well as the accrual of reassuring data from other countries that implemented similar individual behavior (not population) based testing,” said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco.

In 2015, the FDA relaxed an outright ban on donations from gay and bisexual men, but the 2015 guidance asked men to abstain from sex for at least one year before donation.

Under Thursday’s finalized guidance, every prospective donor will be asked about their sexual history within the past three months – regardless of their sexual orientation. If they report a new sexual partner, more than one sexual partner, or having anal sex, they will be deferred. In addition, any person who takes HIV medications intended to treat or prevent infection will be deferred.

The FDA says this move could expand the pool of people eligible to donate blood.

“As a physician I feel a sense of relief, this will likely lead to the increased supply and availability of a vital resource needed for life saving and life sustaining treatment,” said Dr. Darien Sutton, an emergency medical physician and ABC News contributor.

In a press release, the FDA said it has “carefully reviewed numerous data sources” that give the agency “a solid foundation to support this new policy.” The FDA said it strongly believes this new recommendation will not compromise the safety of the blood supply.

In prepared remarks, Dr. Peter Marks, head of the FDA’s CBER division that handles blood donations, said the new recommendations “represent a significant milestone for the agency and the LGBTQI+ community.”

Chin-Hong added, “As a doctor I enthusiastically welcome this news … Above all, this is a victory of science over stigma.”

“The FDA’s decision to follow science and issue new recommendations for all Americans, regardless of sexual orientation, who selflessly donate blood to help save lives, signals the beginning of the end of a dark and discriminatory past rooted in fear and homophobia,” Sarah Kate Ellis, the president and CEO of GLAAD, said in a statement Thursday.

Ellis, however, took issue with one part of the updated recommendation, which urges deferral for anyone taking HIV medications — including people who are HIV negative who are taking medications called PrEP to prevent infection.

The deferral period could continue to erect barriers to LGBTQ blood donors, she said.

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