GREEN BAY, Wis. (WFRV) – Senator Tammy Baldwin is leading a group of Senators and calling for the Food and Drug Administration (FDA) to update its blood donor deferral policies for men who have sex with men (MSM), calling it a ‘discriminatory practice’ that negatively impacts the blood shortage crisis.
Senator Baldwin released a statement Thursday calling the FDA’s three-month donor deferral policy outdated and harmful to not only the national blood shortage but also the LGBTG+ community.
“In addition to decreasing the eligible donor base and depriving patients of needed blood, the current three-month donor deferral blood donation policy for MSM unnecessarily stigmatizes and harms the LGBTQ+ community,” wrote Sen. Baldwin.
The deferral policy in question dates back to 1983 when the FDA first placed a lifetime deferral policy stating that men who have sex with men would not be eligible to donate blood due to an inability to test for HIV.
Thanks to significant advancements in the medical field, thirty-two years later, in 2015, the FDA revised its lifetime MSM donor deferral policy changing it to a 12-month deferral period.
Five years later, in April 2020, the COVID-19 pandemic caused the FDA to lift its 12-month MSM deferral, and move it to a 3-month deferral period. This means gay or bisexual men are not eligible to donate blood if they have had sex with another man within three months of their donation.
The FDA noted in a document released to the public that their decision to shorten the deferral period was ultimately made after careful evaluation of available data indicating that there were no adverse effects on the safety of the blood supply.
However, Senators are now calling that this time-based deferral is removed altogether and replaced with a more inclusive and evidence-based policy, possibly including the usage of blood screenings and available safety technology.
“Given advances in blood screening and safety technology, a time-based policy for gay and bisexual men is not scientifically sound, continues to effectively exclude an entire group of people, and does not meet the urgent demands of the moment,” said Sen. Baldwin.
The American Red Cross responded to the Senators’ statement stating that “The American Red Cross seeks to build an inclusive environment that embraces diversity for all those who engage with our lifesaving mission. As such the Red Cross believes blood donation eligibility should not be determined by methods that are based upon sexual orientation and is committed to working with partners toward achieving this goal.”
Furthermore, the American Red Cross added that they, in partnership with Vitalant, OneBloodstudy, and LGBTQ+ community centers are actively conducting the ADVANCE (Assessing Donor Donor Variability And New Concepts in Eligibility) study, which aims to determine if different, more inclusive eligibility criteria for gay and bisexual men can be used at blood centers nationwide.
This is an active study and takes place in eight different metropolitan locations with high rates of new HIV infections or active Pre-Exposure Prophylaxis programs such as San Francisco, Los Angeles, New Orleans, and Memphis. Participants of the study are gay and bisexual men who voluntarily choose to take part in the study.
The ADVANCE study works by having participants fill out a donor history questionnaire that includes added questions on individual behaviors that may be associated with new HIV infection.
Researchers then take a blood sample from these participants and assess if the addition of these questions would be as effective as a time-based deferral in reducing the risk of HIV among gay and bisexual men who decide to donate blood.
“The ADVANCE study is a first step in providing data that will help the FDA determine if a donor history questionnaire based on individual risk would be as effective as time-based deferral, in reducing the risk of HIV in the blood supply,” said Brian Custer, Ph.D., vice president of Research and Scientific Programs with Vitalant Research Institute.
ADVANCE study experts noted that the study is ongoing but the results are expected in mid-2022. After the results are in, study officials said that their findings will be submitted to the FDA who will review the data and decide the next steps.
“We are hopeful the ADVANCE study will conclude that state-of-the-art testing of the blood supply, combined with an individual risk assessment, will support a change to the blood donor deferral policy so that all men who have sex with men can be considered potential blood donors,” said Denise Spivak, CEO of CenterLink.