FDA drops specific restrictions on blood donation

Norman Ray

Global Courant 2023-05-12 04:11:49

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

The new guideline, first proposed in January and finalized Thursday, will not limit donations based on a person’s sexual orientation or gender identity, but 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 HIV/AIDS crisis of the 1980s. In recent years, the FDA has relaxed, but not completely lifted, these rules.

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

Tubes funnel blood from a donor into a bag in Davenport, Iowa, Nov. 11, 2022.

Charlie Neibergall/AP, DOSSIER

It’s a move long advocated by public health experts and advocates. Proponents say the HIV crisis has changed significantly since the 1980s, undermining 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 about 1 in 5 new HIV diagnoses in the United States, according to the most recent CDC data available.

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

“This change reflects advances in molecular testing and the increase in reassuring data from other countries that have implemented similar testing on individual behaviors (not populations),” 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 guideline asked men to abstain from sex for at least a year before donation.

Under Thursday’s final guidelines, every potential donor will be asked about their sexual history in the past three months — regardless of their sexual orientation. If they report a new sexual partner, more than one sexual partner, or anal sex, they will be deferred. In addition, any person taking HIV medication intended to treat or prevent infection will be deferred.

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

“As a physician, I feel relieved. This is likely to lead to increased supply and availability of a vital resource needed for life-saving and life-sustaining treatments,” said Dr. Darien Sutton, an emergency room physician and ABC News contributor.

In a press release, the FDA said it “has carefully reviewed a large number of data sources” that provide the agency with “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, chief of the FDA’s CBER division that handles blood donations, said the new recommendations “represent an important milestone for the agency and the LGBTQI+ community.”

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

“The FDA’s decision to follow the science and issue new recommendations for all Americans, regardless of sexual orientation, who selflessly donate blood to save lives marks 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, disagreed with part of the updated recommendation, which calls for a delay for anyone taking HIV medications — including people who are HIV-negative and taking drugs called PrEP to prevent infection.

The grace period could continue to create barriers for LGBTQ blood donors, she said.

FDA drops specific restrictions on blood donation

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