February 03, 2023
The Food and Drug Administration expects to issue a final guidance recommending the use of individual risk assessment (IRA) to determine blood donor eligibility before the end of the COVID-19 public health emergency, Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research told the blood community during an AABB Hot Topic Discussion on Thursday, Feb 2.
FDA issued a draft guidance proposing recommendations for new protocols to determine a blood donor’s eligibility and an end the current time-based deferral for men who have sex with men (MSM) last Friday.. Marks joined the AABB event on Thursday to discuss the proposed changes and answer questions from the blood community.
Marks began with an overview of the proposed IRA process in the United States compared with the eligibility criteria of the United Kingdom and Canada. These countries adopted IRA to determine blood donor eligibility in 2020 and 2022, respectively.
Marks also touched on donor deferral rates, including some previously eligible donors who will be ineligible under the new criteria. Modeling data in Canada prior to implementation estimated a deferral rate of 0.74%. In the months following the September 2022 implementation, Canadian Blood Services (CBS) is seeing a a deferral rate of around 0.08%%, which is much lower than predicted in modeling, as described by Mindy Goldman, MD, FRCPC, of CBS during an AABB Jan. 26 Hot Topic Discussion. Marks shared that FDA models for the U.S. predict a donor deferral rate between .37% and 1.07%.
While many LGBT+ advocacy organizations welcomed the proposed move to IRA, some have criticized the other policy changes in the draft guidance, such as the deferral period for pre- and post-exposure prophylaxis (PrEP and PEP) medication used to prevent sexual transmission of HIV infection.
FDA provided an explanation for this deferral, which applies to all individuals taking PrEP, in the draft guidance and in a Jan. 27 news release, stating that the “available data demonstrate that the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results.” FDA first issued this clarification in a December 2019 Safety and Availability Bulletin, “Important Information for Potential Donors of Blood and Blood Products.”
“Public messaging, very rightly so, highly encourages PrEP as appropriate in men who are having sex with other men to prevent HIV transmission,” Marks said. “It’s highly effective. That being said, it’s not perfectly effective.”
In his presentation, Marks further clarified that the deferral is necessary, at least for the time being, because:
“At least in our current state of knowledge of PrEP, we feel like [the policy] supports what is going on, as is the practice in the United Kingdom and Canada,” Marks said. In addition, FDA clarified in a Jan. 27 news release that the “ available data demonstrate that the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results.
Under the revised criteria, individuals using oral PrEP will continue to be deferred from donating blood for 3 months following their most recent dose of oral PrEP. Those using injectable PrEP will continue to be deferred for two years following their most recent injection of PrEP.
Before transitioning to audience questions, Marks encouraged attendees to submit comments on the draft guidance. The comment period closes March 31. AABB is preparing joint comments with other stakeholder organizations, such as America’s Blood Centers, the American Red Cross, and the American Hospital Association.
Throughout the Hot Topic Discussion, attendees had the opportunity to ask Marks questions. These touched on a variety of topics, including the following:
AABB members who were unable to attend Thursday’s Hot Topic Discussion may view a recording online.