FDA Paves The Way For More Gay And Bisexual Men To Donate Blood

ACROSS AMERICA — The Food and Drug Administration on Thursday lifted blanket restrictions on blood donations by gay and bisexual men, instead focusing donor guidelines on an individual risk-based assessment that asks the same questions of everyone, regardless of gender or sexual orientation.

The new rules respond to pressure from LGBTQ+ advocates, blood banks and public health groups to replace a longstanding rule requiring abstinence from LGBTQ+ men before they give blood. The policy has been criticized as discriminatory and based on stereotypes.

In line with rules in place in Canada and the United Kingdom, the new regulations are expected to expand the pool of potential blood donors while maintaining safety guidelines to make sure the blood is safe, the FDA said in a statement on its website.

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, called the new rules “a significant milestone,” both for the agency and the LGBTQ+ community.

“The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations, and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place,” Marks said in the statement.

Under the new guidelines, which the FDA said are based on the latest available science, anyone who has had new or multiple sexual partners or who have had anal sex in the last three months is ineligible for blood donations. The risk of HIV transmission is greater with anal sex than vaginal sex, according to the agency.

Also ineligible is anyone who has engaged in sex work or intravenous drug use in the previous three months, anyone living with HIV, or anyone taking medication to prevent HIV. The drugs are safe and effective, the FDA said, but their use may delay the detection of HIV in tests used for blood screening or give false results.

The FDA has been working on the issue since early last year, when 22 U.S. senators appealed to the agency in a letter to end the “discriminatory” rules based on “inaccurate and antiquated stereotypes.”

“These updated guidelines are a real step forward, ensuring that donors are not evaluated simply for being part of the LGBTQ+ community,” Human Rights Campaign president Kelley Robinson said in a statement.

While calling the new rules “a victory,” Robinson said “real obstacles are going to remain, especially for gay, bisexual and other same-gender loving men” as long as people taking HIV-prevention meds, known as PrEP, are not allowed to donate.

The Human Rights Campaign, the nation’s largest LGBTQ+ civil rights group, on Thursday called on the federal government to make further investments in research and technology to open opportunities for all Americans to become blood donors.”

The new rules will potentially expand the number of people who are eligible to give blood and at the same time ensure the safety of the nation’s blood supply. A 2014 study from the Williams Institute at UCLA said that if restrictions on blood donations by men having sex with men were eliminated entirely, it would increase the total annual blood supply by 2 percent to 4 percent, adding between 345,000 to 615,300 pints of blood every year.

An estimated 6.8 million people need blood transfusions every year, according to the American Red Cross. A pint of blood can save three lives.

The U.S. Centers for Disease Control and Prevention already requires that before donated blood is added to the reserve, it must be thoroughly tested for infectious disease pathogens, including HIV and Hepatitis C. The American Red Cross estimates the risk of a U.S. patient getting a transfusion of donated HIV-positive blood at 1 in 1.5 million.