FDA to Make Long-Awaited Changes to Blood Donation Rules – CNET [CNET]

The new proposals remove restrictions on gay and bisexual men that go back to the 1980s, instead focusing on individual health assessments for giving blood.

The US Food and Drug Administration on Friday announced changes to rules that broadly restrict many gay and bisexual men from giving blood, instead centering donor criteria on individual health screenings, a shift many in the activist and medical communities have advocated for.

The current blood donation guidance bans any man who has sex with men (MSM) from donating blood if they’ve had sex in the last three months. The same waiting period applies to other people who have sex with MSM. 

According to the new rules, which won’t go into effect until the FDA finalizes them in the coming months, MSM and their partners will be able to donate blood without any waiting period. There will still be restrictions on anyone who’s had sex with multiple partners or a new partner within the last three months, and who has also had anal sex within that time frame. The new rules also won’t change restrictions on other criteria, such as recent injection drug use and having sex in exchange for money.

The proposal comes as the US faces a blood supply problem, and is in line with blood donation guidelines in other countries such as Canada and the UK. The FDA said that its draft recommendations are based on a review of available information, including data from countries that already implement the guidelines. 

A safe blood supply and donation process is “paramount” to the FDA, the agency’s commissioner, Dr. Robert M. Califf, said in a news release, and maintaining it is important.

“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,” Califf said. 

Friday’s announcement by the FDA is the latest move to loosen a decades-long practice of stopping men who have sex with men from giving blood. Until 2015, gay and bisexual men weren’t allowed to donate blood at all. In 2020, the FDA shortened its deferral period for men who have sex with men, changing the requirement from waiting 12 months since last sexual contact to three months.

The blood donation rules and bans, largely impacting gay men but also restricting others, including people who’ve gotten tattoos or inject drugs, are based on the assessment of who’s more at risk for contracting human immunodeficiency virus (HIV). The lifetime blood donation restriction on men who have sex with men which expired in 2015 was created in the 1980s, during the HIV/AIDS crisis which disproportionately impacted gay and bisexual men. HIV spreads more easily through anal sex, a focus in the new donation guidance.

But not only has the country moved ahead decades in terms of HIV awareness and prevention, advancements in science and medical testing have extended to blood donations clinics, and they already test donor blood for infectious diseases including HIV and hepatitis B and C.

“This proposed blood donation policy moves the country toward what LGBTQ+ advocates and medical experts have been saying for years,” Kelley Robinson, president of the Human Rights Campaign, said in a press release Friday. “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.”

According to the new guidelines, time-based restrictions for those taking PrEP (an HIV drug that helps prevent infection pre-exposure) and PEP (a drug taken post-exposure) will still be in effect, the FDA said. People taking PrEP and PEP should continue their medication and not stop in order to donate blood, the HRC said.

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