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FDA Affirms Support for Potential Blood Donor Changes to Members of Congress

U.S. Representatives Val Demings, Mike Quigley, Carolyn B. Maloney, Adam Schiff, Barbara Lee, and Ritchie Torres have 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 people who can safely donate blood from doing so.

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 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in Orlando and elsewhere around the country, seeks to modernize the science and collect new data to ensure that these outdated policies can be safely and finally overturned.

The FDA’s response including strong support of the study as the FDA works to “assesses the feasibility and safety of alternative donor eligibility policies.” The FDA goes 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.”

“We are glad to see that the FDA remains committed to supporting the ADVANCE Study and open to updating the agency’s outdated, stigmatizing rules regarding blood donations,” said Reps. Demings and Maloney. “Expanding the number 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 person in the United States.”

“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,” the Members previously wrote. “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.

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 and bisexual 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. Val Demings and Mike Quigley introduced the Science in Blood Donation Act of 2020, legislation to require the Food and Drug Administration 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. Carolyn B. Maloney, Adam Schiff, Mike Quigley, Barbara Lee, and Ritchie Torres led their colleagues in introducing a resolution highlighting the urgent need for equitable, science-based blood donation policies in the United States.

The FDA’s support for the ADVANCE Study is in accord 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.

Researchers have been recruiting men in Orlando, Miami, Atlanta, Memphis, New Orleans/Baton Rouge, Washington D.C., San Francisco and Los Angeles.

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