The agency would like to begin using individual risk-based questions to reduce the risk of transfusion-transmitted HIV.
Today the FDA announced 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.
“Maintaining a safe and adequate supply of blood and blood products in the US 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,” FDA Commissioner Robert M. Califf, MD, said in a statement.
This proposal is in line with policies in place in the United Kingdom and Canada.
The FDA reviewed numerous data sources, including from the United Kingdom and Canada—both countries with similar HIV epidemiology that have implemented this gender-inclusive, individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, and the performance characteristics of nucleic acid testing for HIV. Additionally, FDA funded the Assessing Donor Variability And New Concepts in Eligibility study. This study examined several HIV risk factors, such as anal sex, rates of HIV infection and rates of PrEP and PEP use among MSM study participants.
The FDA laid out the proposed guidance including the following:
Other considerations in the guidance include:
Proposed guidance related to pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP):
This proposal will be open for public comment for 60 days. Afterwards, the FDA will then review and consider all comments before finalizing this guidance, which would then be implemented by the nation’s blood collection establishments through an updated donor history questionnaire.