FDA Proposes Guidelines and Restrictions for Blood Donations

April 05, 2023 by Alec Stone MA, MPA, Former ONS Director of Government Affairs and Advocacy

Taking into consideration the history of HIV/AIDS and upholding COVID-19–related guidelines, the U.S. Food and Drug Administration (FDA) proposed adjusting blood donor (https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply) eligibility from time-based deferrals to assessing donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.

Some main features of the proposed guidance (https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply) include:

FDA said the draft recommendations are from careful review (https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply) of available information, including data from other countries with similar HIV epidemiology that have instituted this approach, as well as surveillance of the U.S. blood supply. Based on the data, FDA believes the implementation of the individual risk-based questions (https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply) 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,” Robert M. Califf, MD, FDA commissioner, said (https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply). “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for 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.”

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