FDA Mulls Modifying Controversial Restrictions on Gay and Bisexual Blood Donors That Advocates Call ‘Outdated'

The federal agency is studying whether to move to a policy based on individual risk

NBC 5 News

The federal Food and Drug Administration is considering further easing restrictions on blood donations by gay and bisexual men, a long criticized policy that first went into effect during the start of the AIDS pandemic, to focus instead on an individual risk of transmitting HIV.

The change would come as the country faces a continuing national blood shortage brought about by the coronavirus pandemic.

A donor eligibility study that is being evaluated and other information available from blood surveillance “will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of HIV transmission,” the FDA said in a statement.

The FDA said it expected to issue updated draft guidance in the coming months.

A ban on blood donations by men who had had sex with another man after 1977 was implemented in the early 1980s to try to keep the virus that causes AIDS out of the blood supply. The first test to screen blood for HIV was developed by Abbott Laboratories of Chicago in 1985.

The rule was changed in 2015 to sex within the past 12 months -- a policy that received scrutiny when gay men were unable to donate after the massacre at the Pulse nightclub in Orlando, Florida -- and again on April 2 to sex within the last three months. The most recent loosening was in response to a drop in blood donors during the coronavirus pandemic. 

The American Red Cross and blood banks across the nation are putting out an urgent call for donors amid the COVID-19 pandemic. As the virus spreads and events and businesses close, donations are dropping, dangerously in some areas.

The donor eligibility study — the Assessing Donor Variability And New Concepts in Eligibility or ADVANCE pilot study — concluded in September but the FDA said it continued to review the results. 

It is evaluating a donor questionnaire intended to assess the risk of a possible HIV or other infection. If the scientific evidence supports the use of the questions, men who have sex with men would be assessed on their own risk for HIV infection and not according to their last sexual contact, according to the study.

The study “has generated data that will help the FDA determine if a donor questionnaire based on individual risk assessment would be as effective as time-based deferrals in reducing the risk of HIV,” the agency said.

The FDA funded the study, which was conducted at community health centers in key locations across the United States by three of the country’s largest blood centers, Vitalant, OneBlood and the American Red Cross.

The FDA said it was determining the next steps including when and how results of the study may be made public. 

In March 2020, when coronavirus-related blood shortages were appearing, a group of medical professionals urged the U.S. government to allow donations without restriction.

"Banning men from blood donation for at least a year since their most recent sexual encounter with a man is unscientific and based on outdated antibody-based HIV testing algorithms," it read.

LGBTQ advocates called the restrictions antiquated. Sarah Kate Ellis, CEO and president of the nonprofit advocacy GLAAD, said at time, "The FDA needs to put science above stigma."

This week, Ellis said in a statement that the although the FDA’s step was important, the LGBTQ community would not stop advocating for the agency to lift all restrictions on qualified blood donors. 

“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,” she said. “Giving one set of rules to some people, and another set of rules to others, based purely on identity, is blatant discrimination.”

The American Blood Centers tracks the national blood supply daily at 59 community blood centers. As of Thursday, 15 had a 1-day supply or less.

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