Draft guidance marks first step in process towards official change in donor eligibility

MIDDLETOWN — Connecticut Blood Center (CTBC) today applauds the Food and Drug Administration’s (FDA) updated guidance that would establish blood donor screening based on an individualized assessment approach, not sexual or gender identity.

“Connecticut Blood Center is pleased to learn the FDA is recommending science-based, all-inclusive guidance that will allow us to welcome new donors,” said Jonathan DeCasanova, Connecticut Blood Center Account Manager. “While enacting these guidelines is still several months away, we believe this will play a pivotal role in helping stabilize the blood supply and save lives in our community.” 

All U.S. blood centers are regulated by the FDA and must adhere to their donor eligibility policies. In 1983, the FDA instituted a lifetime deferral on blood donations for gay and bisexual men in order to reduce the chance of HIV in the blood supply at a time when testing was limited or non-existent. In 2015, the FDA revised this policy and moved to a 12-month deferral for men who have sex with men in response to comprehensive testing capabilities and data demonstrating safety in shortened deferral. This policy was revised again in 2020 to the current 3-month deferral.

These latest proposed changes are based on data from the “Assessing Donor Variability and New Concepts in Eligibility” (ADVANCE) Study, which sought to determine if different eligibility criteria could be used by focusing on each donor’s individual risk behavior rather than their sexual orientation. Today’s updated guidance reflects the scientific data gathered as part of the ADVANCE Study. ADVANCE Study results will be released in the coming year.

The new draft guidance is the first step in a lengthy process of welcoming previously deferred individuals as blood donors. The entire process will involve a public comment period, final guidance, revised donor questionnaires, and finally updated operational procedures, information systems, and staff training. The draft guidance has a 60-day comment period, after which the FDA will issue final guidance.

Details of the draft FDA guidance for Individual Risk Assessment:

  • The time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.
  • The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
  • Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months.
  • All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.
  • Under this proposal, a prospective donor who does not report having new or multiple sexual partners, may be eligible to donate, provided all other eligibility criteria are met. 

Upon final guidance issuance, blood collection establishments will update their software and train staff. Centers will use the approved uniform donor history or submit their new questionnaires to FDA. The above steps could take 6 months to 1 year to implement.