FDA proposes risk-based rules for plasma and blood donations

05/17/2023

Update: On May 11, 2023, the U.S. Food and Drug Administration finalized the recommendations for an individual risk assessment to determine donor eligibility for blood and plasma donations. This set of individual risk-based questions will "reduce the risk of transfusion-transmitted HIV," The questions will be standard for every individual donor, "regardless of sexual orientation, sex or gender." 

The new policy eliminates the previous time-based deferrals and screening questions only specific to men who have sex with men (MSM) and women who have sex with MSM. Now, all potential donors who report having a new sexual partner, more than one sexual partner in the last three months, and anal sex in the last three months would be deferred. 

On January 27, 2023, the U.S. Food and Drug Administration announced a draft proposal for eligibility rules for blood and blood product donation using “gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.” The new assessment for donations will replace the current guidelines while continuing to safeguard the U.S. plasma and blood supply and is in line with policies that are already in place in Canada and the United Kingdom

According to the draft guidance, the new guidance for blood donor eligibility includes source plasma donations as well. The FDA carefully considered data from other countries with similar HIV epidemiology and the state of the current U.S. blood supply. The guidance states, “Based on the available data, the agency [FDA] believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply.”

The highlights of the new guidance proposal:

  • The elimination of time-based deferrals for men who have sex with me (MSM) and women who have sex with MSM.
  • Revisions to the current language surrounding blood and plasma donation to put emphasis on specific behaviors and not gender, identity, and sexual orientation.
  • Revisions to the current donor history questionnaire to include questions on new sexual partners or more than one sexual partner in the past three months.
    • If the potential donor reports that they have had a new sexual partner or more than one sexual partner AND have had anal sex in the past three months, they would be deferred from donation.
    • If the potential donor reports that they have not had new or multiple sexual partners and anal sex in the past three months, they may be eligible to donate, provided all other eligibility and criteria are met.
  • No change in the donor lifetime deferral for other HIV risk factors, which include those who have exchanged sex for money or drugs or have a history of non-prescription injection drug use.
  • No change to lifetime deferral for those who have ever had a positive test for HIV or who have taken any medication to treat HIV infection.
  • Continued requirements for donation centers to test all blood and blood product donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B, and hepatitis C. 
  • Those taking oral medications to prevent HIV infection (oral PReP) would be deferred for three months from their most recent dose because PReP can mask new HIV infection from diagnostic tests.
  • Those taking injectable pre-exposure prophylaxis (injectable PrEP) to prevent HIV infection would be deferred for two years from their most recent injection. 

This progress still comes with some limitations and restrictions for donors. The release from the FDA states, “the agency recognizes that, while these draft recommendations, when finalized, will potentially increase the number of individuals eligible to donate blood, some individuals will still be deferred from donating blood.”

The FDA will now collect public comment for 60 days before reviewing and finalizing this guidance. If the guidance is finalized, it will be a huge advancement for both blood and plasma donations. Plasma and blood donations are invaluable to many people, and the new safety regulations will ensure that only the safest donations are used while allowing more donors to make an impact. 

Interested in learning about the differences between blood and plasma donation? Find out here.

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