The U.S. Food and Drug Administration announced January 27 it is proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.
These draft recommendations are based on the FDA’s careful review of available information, including data from other countries with similar HIV epidemiology that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply. Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply.
“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf, M.D. “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”
Under the new proposed guidelines, the time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated and 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. A prospective donor who does not report any of the above will likely be eligible to donate
Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose and those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection because available data indicates the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results.
“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, M.D., Ph.D., 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.” As part of the FDA’s established process, the proposal will be open for public comment for 60 days. The agency will then review and consider before finalizing.