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New FDA Guidance for Long-standing Deferral; HIV Changes

Image of New FDA Guidance for Long-standing Deferral; HIV Changes. The Food and Drug Administration has issued new guidance on blood donations, removing some long-standing deferrals. In addition to this, the FDA is also considering moving towards an individualized risk-based approach when deciding donor eligibility. These changes are related to HIV medications and those at risk for contracting HIV. (credit: Swati Agani)

The Food and Drug Administration issued new guidance in May for blood donors, removing and adjusting some long-standing deferrals. In addition, the FDA is also now moving towards an individualized risk-based approach when determining donor eligibility. The Armed Services Blood Program is reviewing this newly issued guidance and plans to implement it in the coming months.

One of the most significant changes is that the FDA now recommends “...eliminating the screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Instead... [they are now recommending] assessing donor eligibility using the same individual risk-based questions relevant to HIV risk for every donor regardless of sex or gender,” according to the FDA announcement. Instead, guidance would shift to a three-month deferral based on recent sexual contact with new partner(s) in addition to recent high-risk sexual activity in the past three months. Donors previously deferred for positive responses to screening questions specific to MSM, may be re-assessed for blood donation.

“The Armed Services Blood Program, as well as all civilian blood collection programs, are closely regulated by the FDA. We closely review, and safely implement each guidance issued by the FDA,” explained U.S. Navy Capt. Leslie Riggs, division chief of ASBP. “This one is no different. We welcome the thoroughly researched and safe changes the FDA has provided which has the possibility to increase the donor pool. This change will provide more people with the opportunity to donate blood, and ultimately, when you donate, you can help save a life.”

The FDA ensured that safety will not be compromised, stating “In considering the available data, we believe implementation of the individual risk-based approach recommended in this guidance will maintain the current high level of safety of blood and blood components, including source plasma in the U.S.”

“Blood product safety will always be our number one priority,” said Tamara Clayton, quality assurance specialist, ASBP Division. “We are in the process of analyzing these new recommendations and will be implementing them soon. This updated guidance better reflects the current donor landscape, but more importantly, these recommendations are backed by sound research that has been conducted worldwide.”

As this deferral is being lifted, another deferral is being updated out of an abundance of caution. This deferral affects those who have taken or are taking any medication to prevent or treat HIV infection. Newly issued FDA guidance recommends a three-month deferral from the most recent dose of an oral medication, such as a short-acting antiviral HIV pre-exposure prophylaxis drugs, otherwise known as PrEP, and a two-year deferral is recommended from the most recent injected version of the medication (I.e., long-acting antiviral PrEP). A permanent deferral is in place for an individual who has ever taken any medication to treat an HIV infection.

Please get in touch with your local ASBP blood donor center if you have specific questions or concerns about your eligibility to donate.

Armed Services Blood Program

Since 1962, the Armed Services Blood Program is the official blood program of the United States military. Our mission is to provide quality blood products and support to military health care operations worldwide; from the battlefield to the local hospital, whenever and wherever needed. The ASBP collects, processes, stores, transports, and distributes blood products to service members, their families, retirees and veterans in peace and war. In an ASBP Enterprise view – Military Health Affairs, Defense Health Agency, Service Blood Programs and Combatant Commands – we operate under common goals, metrics, procedures, and work together to shape the future.

The ASBP is one of four organizations tasked with providing a safe blood supply to the nation. Our program also works closely with our civilian counterparts in times of need to maximize the availability of this national treasure.

To find out more about the ASBP or schedule an appointment to donate, please visit interact directly with ASBP staff members or get the latest news, follow us @militaryblood on Facebook and Twitter, and @usmilitaryblood on Instagram.

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Last Updated: June 27, 2023
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