U.S. Representatives Val Demings, Mike Quigley, Carolyn Maloney, Adam Schiff, Barbara Lee, and Ritchie Torres sent a letter to U.S. Food and Drug Administration Acting Commissioner Dr. Janet Woodcock pushing an effort to end LGBTQ+ discrimination in blood donations. Writing in advance of the 5th anniversary of the Pulse Shooting, the members stated strong support of the Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) Study.
“We applaud the FDA’s decision to launch a pilot study that will utilize an individual blood donation questionnaire to assess risk factors that could indicate possible infection with a transfusion transmissible infection, including HIV,” wrote the Members. “We appreciate that the FDA has been willing to engage in discussions specific to the MSM deferral policy and revise guidance following Pulse, which included modifying the blanket ban to 12-months and again to 3-months deferral periods. These are steps in the right direction, but ultimately reductions in the ban should not be tied specifically to sexual orientation or disaster-based supply issues. An individual’s personal risk profile, regardless of sexual orientation and based on scientific and technological progress, should guide the policy.”
“After the Pulse Shooting five years ago, we swore to honor the victims with action, not just words,” Rep. Demings said. “I will forever be proud of how our community came together following the shooting to offer support and comfort to the survivors and their families. But as dozens of our neighbors and friends were fighting for their lives, many in our LGBTQ community were prohibited from donating blood due to an outdated policy not based on science.”
On June 12, 2016, 49 people were killed and 53 others shot and injured at the Pulse Nightclub, an LGBTQ+ gathering place in Orlando. The community rallied to support the victims and survivors, but many gay and bisexual men were prohibited from donating desperately needed blood due to outdated and discriminatory FDA donor policies.
“After working on this issue for years, I am grateful that the FDA is finally taking steps to update the science and take the next steps towards finally expanding the pool of American blood donors and helping us to save lives and give every American the best possible chance to survive when tragedy strikes,” Rep. Demings added. “I strongly encourage any Central Floridian who wants to participate in this important and groundbreaking study to contact The Center for more information.”
The ADVANCE Study, which includes efforts in Orlando and elsewhere around the country, seeks to modernize the science and collect new data to ensure that these outdated policies can be safely and finally overturned.
Current FDA policy bans blood donors who are men who have had sex with other men within the last three months. In 1983 when the policy was put in place, it was in the form of a lifetime ban on gay men from donating. This was changed to a year-long deferral in 2015, and three months in 2020. In 1983, there was no way to screen blood for HIV. Today, however, all donated blood is screened, leaving this policy woefully out of date.
Last year, U.S. Reps. Demings and Quigley introduced the Science in Blood Donation Act of 2020, legislation to require the FDA to revise its Guidance on Reducing the Risk of Human Immunodeficiency Virus Transmission (HIV) by Blood and Blood Products based on an assessment of current testing accuracy and individual risk-based analysis, rather than categorization. It would also require the FDA to revise the donor questionnaire based on an individual risk assessment of sexual behaviors upon which all donors are evaluated equally, without regard to sexual orientation or gender identity to remove LGBTQ+ discrimination in blood donations.
The advancement of the ADVANCE Study is a voluntary move which puts them in compliance with the goals of the Science in Blood Donation Act. Prior to the study’s announcement in December, the FDA had resisted calls to utilize a scientifically based risk assessment. The Science in Blood Donation Act and the Members’ resolution were key steps that encouraged FDA to further reevaluate this outdated policy.