FDA relaxes blood donation rules for gay and bisexual men in the US

A nurse places a plaster on an individuals arm after they have just donated blood.

Gay and bisexual men in the US will finally be able to donate blood more easily thanks to new rules introduced on Thursday (11 May).

Guidelines announced by the Food and Drugs Administration (FDA) in January have reportedly been finalised and will ease restrictions for LGBTQ+ men wishing to donate.

Under the new rules, all donors are required to complete an individualised risk assessment, regardless of gender or sexuality, while those who have had anal sex with more than one partner in the last three months must wait before donating blood.

Changes also include the elimination of time-based deferrals for gay men and women based on their sexuality alone.

Risk assessments include questions on an applicant’s sexual history to help mitigate HIV risk factors. Those who have had a positive HIV test in the past will be deferred permanently.

“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products,” FDA Biologics Evaluation and Research director, Dr Peter Marks, said in a statement.

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“The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQ+ community.”

‘A real step forward’

Campaigners have been advocating for the FDA to update its policy for several years following the lift of its complete ban on the LGBTQ+ community in 2015.

Following the further relaxing of restrictions of blanket deferrals from 12 to three months due to blue shortages caused by the COVID-19 pandemic, activists urged the regulatory body to switch to risk-assessments to help end discrimination and keep blood safe.

Recommendations to use the assessments were proposed in November 2022 after research found that they would be more effective against potential risks rather than deferrals.

In a report, Vitalant Research Institute director Brian Custer said the body had a “strong data set” that backed up the effectiveness of risk assessments.

FDA commissioner Robert M. Califf then announced in January 2023 that a policy overhaul using the research as justification would go ahead later this year.

“Maintaining a safe and adequate supply of blood and blood products in the US is paramount for the FDA,” he said in a statement.

“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.”

The Human Rights Campaign celebrated the overhauled policy but reiterated that more needs to be done to “prioritise investing in more technologies and research to allow more people to donate blood.”

HRC president, Kelley Robinson, said: “These updated guidelines are a real step forward, ensuring that donors are not evaluated simply for being part of the LGBTQ+ community.

“Science advanced, making it possible for FDA to modernise its guidelines with full confidence in the safety of the blood supply.

“We’re calling on the federal government to make further investments in research and technology to open opportunities for all Americans to become blood donors.”

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