(Photo by Vegasjon, from Wikimedia Commons)
ORLANDO | The Food and Drug Administration announced that it will be changing the way it assesses blood donor eligibility from time based to risk based, allowing gay and bisexual men who were previously banned to donate blood.
In a press release Jan. 27, the FDA stated it is “proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.”
Under the new proposed guidelines, a revised donor history questionnaire would ask each donor questions about sex partners in the past three months. Prospective donors who report having new sex partners or more than one sex partner in the past three months would then be asked about a history of anal sex in that timeframe. If the prospective donor answers yes to having anal sex in the past three months, they would be deferred from donating.
The new proposal would not change the deferral time periods for those who are taking pre-exposure prophylaxis or post-exposure prophylaxis, have exchanged money or drugs for sex, or have a history of non-prescription injection drug use.
“Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in the press release. “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”
The change comes based on information obtained from the FDA-funded Assessing Donor Variability And New Concepts in Eligibility, or ADVANCE study. The study was conducted by Vitalant and OneBlood, the two largest community-based blood centers in the U.S., and the American Red Cross and was done in partnership with LGBTQ community centers in the country, including the LGBT+ Center Orlando.
“The policies that discriminate against gay and bisexual men are outdated and stigmatizing and I hope that The Center Orlando can play even a small role in getting these changed. It is a subject that I am passionate about so when the opportunity to work on the national study came about, I knew that I wanted Orlando to be part of it,” said Dr. George Wallace, The Center Orlando’s CEO, in late 2020 as the study was getting started.
The current changes are the latest in a long-fought battle between LGBTQ rights groups and the FDA. A lifetime ban was placed on men who have sex with men donating blood in the 1980s due to the AIDS epidemic. In 2015, the FDA replaced the lifetime ban with a one-year abstinence requirement. The agency shortened the abstinence period to three months five years later.
“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf, M.D., in the release. “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and 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 FDA states that this new proposal is in line with policies in place in countries like the United Kingdom and Canada.
As part of the FDA’s established process, the new proposal will be open for public comment for 60 days. The agency will then review and consider all comments before finalizing the guidance, which would then be implemented by the nation’s blood collection establishments through an updated donor history questionnaire.
