Chicago, Ill. — Last week, Reps. Mike Quigley (IL-05), Val B. Demings (FL-10), Carolyn B. Maloney (NY-12), Adam B. Schiff (CA-28), Barbara Lee (CA-13), and Ritchie Torres (NY-15) received a response to the letter they previously sent to U.S. Food and Drug Administration (FDA) Acting Commissioner Dr. Janet Woodcock in support of efforts to update the science and ensure that the FDA can safely end discriminatory policies which prohibit healthy donors from giving blood.
Originally writing in advance of the 5th anniversary of the Pulse Shooting, the members had stated strong support of the Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) Study.
The FDA's response includes strong support of the study as the FDA works to "assesses the feasibility and safety of alternative donor eligibility policies." They go on, "the Agency remains committed to considering alternatives to the time-based deferrals currently in place for MSM, that are based on scientific data and that will maintain a high level of blood safety."
Said Reps. Quigley, Demings, Maloney, Schiff, Lee, and Torres: "We are glad to see that the FDA has committed to supporting the ADVANCE Study and remains open to updating their outdated, stigmatizing rules regarding blood donations. Expanding the pool of American blood donors will help us to save lives when tragedy strikes. This is an important step towards fairness and equality for all. We will continue to watch carefully and follow the best possible science in our work to create justice in our blood donor system and ensure the health and safety of every American."
The Members previously wrote, "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."
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the victims and survivors, but many gay and bisexual men were prohibited from donating desperately needed blood due to outdated and discriminatory FDA donor policies.
The ADVANCE Study, which is currently being conducted 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. Mike Quigley (IL-5) and Val Demings (FL-10) and introduced the Science in Blood Donation Act of 2020, legislation to require the Food and Drug Administration (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.
In April, U.S. Reps. Mike Quigley (IL-5), Carolyn B. Maloney (NY-12), Adam B. Schiff (CA-28), Barbara Lee (CA-13), and Ritchie Torres (NY-15) led their colleagues in introducing a resolution highlighting the urgent need for equitable, science-based blood donation policies in the United States.
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.
