FDA plans to lift blanket restrictions on blood donations from gay men

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The Food and Drug Administration plans to further ease a decades-old prohibition on donating blood by men who have sex with men that has long been called discriminatory by LGBTQ advocates.

On Friday, the FDA announced plans to ask people specific questions about their HIV status and medication, rather than having a blanket prohibition. Surveillance of the blood supply would continue, so the agency said the shift in policy would not compromise public safety.

“Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so,” FDA Commissioner Dr. Robert Califf, said in a statement.

Advocates praised the move.

“Today’s announcement represents an important first step toward dismantling an antiquated and discriminatory blood donation policy that restricts gay, bisexual, and other men who have sex with men from donating blood,” Human Rights Campaign President Kelley Robinson, said in a statement.

FDA to shift focus from gender and sexual orientation

Under the draft recommendations, would-be donors would be asked about their HIV status and whether they were taking medications to treat or prevent HIV.

Previously, men who have sex with men had to abstain from any sexual activity for at least three months before donating. The new proposal would eliminate the time deferral.

According to the proposal, the donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.

Those who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months. If they had a new sexual partner or anal sex, they would be asked to defer donation for three months.

Anyone who exchanged sex for money or drugs or has a history of non-prescription injection drug use would still be excluded from donation, as would anyone who has tested positive for HIV.

What about those taking PrEP?

People taking oral medications to prevent HIV infection, including PrEP or PEP would be asked to defer donation for three months after their last dose, though the agency said people taking these medications should not stop them in order to donate blood. Those taking injectable PrEP to prevent HIV infection would have to wait two years after their shot before donating.

The FDA promised to continue tracking the latest data relevant to PrEP and blood donation.

The draft proposal will be open for public comment for 60 days. After reviewing and considering comments, the guidance will be finalized. It will then be implemented by the nation’s blood collection establishments through an updated donor history questionnaire.

FDA EASES RULE AMID SHORTAGE:FDA relaxes restrictions on blood donations from gay and bisexual men during coronavirus pandemic

Previous rule: Gay, bisexual men had to wait 3 months

Blood donation guidelines for gay men were first implemented as the HIV/AIDS crisis unfolded in the 1980s and initially constituted a lifetime ban for gay men. That was revised in 2015 to the one-year restriction, but many LGBTQ rights advocates have long considered these restrictions to be discriminatory.

The FDA previously rolled back some of the guidelines to meet a demand for donated blood early on in the COVID-19 pandemic. Then, its guidance was updated to prohibit men who have had sex with men in the last three months from donating, down from the previous waiting period of 12 months.

Advocates say more needs to be done

Advocates say any restrictions that focus on a donator’s sexuality are misguided and unnecessary given modern blood testing capabilities. All donated blood is screened for HIV and other infectious diseases.

PERSPECTIVE:Red Cross is asking for blood donations amid the omicron surge. Because I’m gay, I’m excluded.

“LGBTQ+ advocates and other health advocate leaders have worked for decades to pressure the FDA and other regulatory agencies to update policy and move toward adopting an approach rooted in science, not in identity,” Robinson said. “So while today’s announcement is a victory, it’s not the end of the road; there is much more that needs to be done.”

Canada’s health department made a similar move last year to focus on higher-risk sexual behavior, such as anal sex with multiple partners within three months, rather than on gender or sexual orientation. The United Kingdom made a similar move in 2021.

Still, other advocates said they are pleased the FDA has finally acted to reverse the long-standing policy.

“These changes are 40-plus years in the making, and are a tremendous leap forward toward elevating science over stigma,” Sarah Kate Ellis, president and CEO of GLAAD, said in a statement. “The announcement today will ease historic discrimination against LGBTQ Americans, help alleviate the national blood shortage, and opens the door for all eligible LGBTQ people to give blood and save lives.”

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