REGULATORY UPDATE: FDA Releases New Draft Guidance on Individual Risk Assessment for Blood Donors

Today, the Food and Drug Administration released a new, highly anticipated draft guidance, “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of HIV Transmission by Blood and Blood Products.” The new guidance offers sweeping new recommendations for determining blood donor eligibility and revising deferrals for men who have sex with men (MSM). FDA is recommending the elimination of time-based deferrals for MSM and women who have sex with MSM. 

AABB recognizes FDA’s careful consideration of new data supporting evidence-based changes to update donor eligibility criteria while protecting the safety of the blood supply.

FDA is now recommending the implementation of a new donor screening process that uses gender-inclusive, individual risk-based questions relevant to HIV risk. In addition, consistent with AABB’s Association Bulletin #22-03, FDA is recommending a deferral for any individuals using medications to treat or prevent HIV infection, including pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP) and antiretroviral therapy (ART).

FDA retained many of the existing HIV deferral recommendations and added a number of significant changes to donor eligibility policy. The recommendations closely align with Canadian Blood Services’ donor eligibility criteria, which was implemented in September 2022. The AABB Donor History Task Force (DHTF) proactively created an Example Model Individual Risk Assessment (IRA) Donor History Questionnaire (DHQ), based on the Canadian model and shared it with FDA in late 2022 for consideration.

A Closer Look at the Recommended Updates
Notably, today’s draft guidance recommends the removal of the following donor eligibility requirements:

• Defer for three months from the most recent sexual contact, a man who has had sex with another man during the past three months.
• Defer for three months from the most recent sexual contact, a female who has had sex during the past three months with a man who has had sex with another man in the past three months.

In addition, FDA is recommending the following changes to donor eligibility:

• Defer permanently an individual who has ever taken any medication to treat HIV infection (i.e., ART).
• Defer for three months from the most recent dose, an individual who has taken any medication by mouth (oral) to prevent HIV infection (i.e., short-acting antiviral PrEP or PEP).
• Defer for two years from the most recent injection, an individual who has received any medication by injection to prevent HIV infection (i.e., long-acting antiviral PrEP). 
• Defer for three months from the most recent sexual contact, an individual who has had a new sexual partner in the past three months and who has had anal sex in the past three months.
• Defer for three months from the most recent sexual contact, an individual who has had more than one sexual partner in the past three months and who has had anal sex in the past three months.

To inform these draft recommendations, FDA reviewed numerous data sources, including data from the United Kingdom and Canada, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, data assessing performance characteristics of nucleic acid testing for HIV, and results from the FDA-funded Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study.

“Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”

AABB appreciates the work of the DHTF in proactively preparing for today’s draft guidance. The DHTF will continue to provide resources and will create a draft DHQ to reflect these new recommendations, which will require minor changes to the example model IRA DHQ. This draft DHQ will expedite the process for submission of a new IRA DHQ to FDA for formal review and acceptance after a final guidance has been issued. Additionally, AABB will provide its members and the community with additional materials and communications related to this policy change.

FDA is encouraging comments on the draft guidance before it begins work on the final guidance, scheduled for 60 days from today. Comments can be submitted to FDA through its website.

Members may contact regulatory@aabb.org with questions.

Additional information about individual risk assessment and the Canadian model was provided by AABB during a Hot Topic Discussion yesterday. A summary of this discussion is available on the AABB Newsfeed.