How a potential change to FDA's blood donor policy could save lives

ByMARY KEKATOS ABCNews logo
Friday, December 2, 2022
How a potential change to FDA's blood donor policy could save lives
In this March 23, 2021 file photo Phlebotomist Adel Velasco prepares a blood donation at a Red Cross blood drive with L.A. Care Health Plan in Los Angeles.
ABCNews

The U.S. Food and Drug Administration is considering updating its blood donation policy, which currently places some restrictions on blood donations from sexually active gay and bisexual men.

In a statement, an FDA spokesperson said, "While we can't comment on what might be in the content of the guidance, we can say that the screening policy we put forward will be gender neutral and science-based."

The announcement on Wednesday was made on the eve of World AIDS Day, a day to spread awareness of and dismantle the stigma associated with the disease.

Public health experts and advocates said relaxing restrictions doesn't only help battle stigma but could also help address future blood shortages.

"The plan for the FDA to revise its donation guidelines is absolutely a step in the right direction because what it does is it's going to move the criteria from a population-centered approach to a risk-approach," Dr. Perry Halkitis, dean of Rutgers School of Public Health whose research focuses on HIV and disparities in the LGBTQ population, told ABC News.

A ban on gay and bisexual blood donors began during the HIV/AIDS crisis in the 1980s, which primarily affected gay and bisexual men. The FDA banned all donations from men who have sex with men in 1985 in response to the crisis.

This restriction remained in place until 2015, when the policy was changed to allow such donors to give blood if they abstained from sex for one year. In 2020, amid severe blood shortages during the start of the COVID-19 pandemic, the FDA shortened the abstinence period to 90 days.

"At the time of the initial epidemic, we had no way of identifying and testing for AIDS and HIV," Ayako Miyashita Ochoa, an adjunct professor at the UCLA Luskin School of Public Affairs whose research focuses on HIV-related health disparities, told ABC News. "What radically shifted over the decades is that testing came online a long time ago, So, at the point in which we were able to identify the virus, I believe that the lifetime deferral became outdated."

If a policy change is implemented, gay and bisexual men in monogamous relationships can donate without abstaining from sex. It follows several other Western countries that have recently dropped bans or eased restrictions including the United Kingdom, France, Greece and the Netherlands.

Activists said these restrictions are based solely on identity rather than individual risk because the ban even applies to gay men who are monogamous, test HIV negative and practice safe sex.

"There is a perception that being a gay or bisexual person is in and of itself unsafe," Sarah Warbelow, the legal director at Human Rights Campaign, told ABC News. "We have to differentiate between what are behaviors that place people at risk -- and that's all people at risk --" and identity based restrictions.

"Not every gay man is the same, not every bisexual man is the same, not every straight person is the same," Halkitis added. "And so recognizing that people are -- within each population -- diverse is a much better way to assess the risks that people take and then deciding based on people's risk."

The American Red Cross and the American Medical Association have both supported a risk-based approach to donor eligibility.

The FDA said there is no "specific timeline" for the update because the agency is currently collecting and analyzing data from multiple sources. However, in a statement to ABC News, the FDA says the evidence analyzed so far will "likely support a policy transition" that focuses screening blood donations based on each person's HIV risk.

In 2020, the FDA launched a study called ADVANCE to look into alternative solutions to its current policy. The FDA is currently reviewing research from the American Red Cross, OneBlood and Vitalant to determine if eligibility based on an individual's risk can replace the current time-based deferral system while maintaining the safety of the blood supply.

Despite the growing research on HIV/AIDS, as well as the success in tackling and treating the illness, the shame and stigma against the LGBTQ community remains.

"As LGBTQ leaders and medical experts have been saying for years: bans and restrictions on blood donations from gay and bisexual men are rooted in stigma, not science," said Sarah Kate Ellis, president and CEO of GLAAD.

She continued, "Giving one set of rules to some people, and another set of rules to others, based purely on identity, is blatant discrimination. This fight is not over until all LGBTQ Americans who want to donate blood are met with the same protocols as other Americans."

Experts say the updated policy will also help address the national blood shortage and, in turn, save lives. In January 2022, the American Red Cross said it was facing its worst blood shortage in more than a decade.

A 2014 study co-authored by Miysahista Ochoa found that eliminating the ban could increase the donation supply by 2% to 4%, bringing in more than 615,000 pints of blood every year.

"That isn't a small amount," she said. "That 2 to 4% count is roughly calculated to a million lives saved."

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