We Are Blood Supports FDA Guidance Regarding Donor Eligibility Updates

Posted: May 12, 2023 | Category: Latest Articles

What’s happening?

On May 11, the FDA issued new guidance that when implemented will update donor eligibility for blood centers across the United States.

This new guidance will update We Are Blood’s donor eligibility questions regarding sexual activity, which will be asked of all donors regardless of gender. The updated guidance is based on results of the FDA’s ADVANCE study and continues to maintain the safety of our community blood supply. As the sole provider of blood and platelets for the Central Texas community, We Are Blood supports the new FDA guidance and will be in the process of implementation.

What is the new guidance?

The new FDA guidance recommends (1) the removal of donor eligibility questions that consider the gender of a donor and their sexual partners and (2) the implementation of new donor eligibility questions related to sexual activity that do not consider gender.

Prior FDA guidance required a three-month deferral for any male who has had sex with another male in the past three months.

Once the new FDA guidance is implemented at We Are Blood, the following donor eligibility questions will instead be asked of all individuals who arrive to donate at our donor centers and mobile drives:

  • All potential donors will be asked if they have had new or multiple sexual partners in the past three months.
  • If answering yes to either, a potential donor would then be asked about a history of anal sex in the past three months.
  • If a potential donor has had a new sexual partner or more than one sexual partner and had anal sex in the past three months, they will be deferred from donation for three months.
  • Under the new FDA guidance, a potential donor who has had anal sex in the past three months, but no new or multiple sexual partners, may be eligible to donate, provided all other eligibility criteria are met.

What about PrEP or PEP HIV medication?

Medications taken to prevent or reduce the likelihood of HIV infection (PrEP or PEP) will result in deferral for three months if taken as an oral medication or two years if taken via injection. These medications may delay HIV detection by screening tests for blood donations, potentially resulting in false negative results.

FDA studies have determined that while these medications reduce the viral load of HIV to a level that reduces the risk of transmission during sexual activity, the risk remains for transmission during a potential blood transfusion due to the large volume in a blood transfusion.

We Are Blood recommends that potential donors follow the advice of their physicians about taking PrEP or PEP medications and does not recommend stopping any prescribed medication to be able to donate blood.

Will the blood supply be safe?

The FDA undertook the ADVANCE study in coordination with multiple blood centers across the country to analyze and study the potential impact to the safety of the blood supply if this new guidance were to be implemented.

The FDA’s issuance of this new guidance is a result of extensive research and scientific data which determined that the safety of the blood supply would be maintained. The new guidance shows confidence in the integrity of blood center donation testing and the benefit of applying the same eligibility questions to all individuals regardless of gender.

When will the new FDA guidance be implemented at We Are Blood?

We Are Blood is excited to implement this new FDA guidance and welcome donors with the new questionnaire. However, many steps remain along the road to implementation.

AABB has developed a uniform questionnaire for all the blood centers that honors the new guidance. This questionnaire was formally recognized by the FDA on May 11, 2023. Now that these important steps have occurred, We Are Blood will begin updating our procedures, systems, and staff training to implement this new donor history questionnaire.

Please stay tuned to our website, blog, and social pages for updates on We Are Blood’s implementation of this new FDA guidance and when the new questionnaire will be made effective.