FDA Proposes Blood Donation Changes

On Friday, January 27, 2023, the U.S. Food and Drug Administration announced proposed changes to national blood and plasma donation policies. The draft FDA guidance, if finalized, would eliminate time-based donation deferrals for men who have sex with men. Instead, revised donor history questionnaires would ask all donors (regardless of gender) to answer individual risk-based questions, designed to reduce the risk of transfusion-transmitted HIV.

FDA notes that its revised draft guidance aligns with policies in place in countries such as Canada and the United Kingdom. FDA also reports that its recommendations are supported by national and international blood safety data, including information collected through FDA’s ongoing surveillance of the U.S. blood supply. “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA,” said FDA Commissioner Robert Califf, “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.”

HFA, on our own and in coalition with other organizations representing patients who use blood products, has consistently advocated that blood safety policies must be based on science and must protect the health and safety of the end user. HFA will continue to champion these principles as we participate in the 60-day comment period on the proposed guidance.