FDA Proposes Guidelines and Restrictions for Blood Donations
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.
- Eliminating time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM
- Revising the current donor history questionnaire to ask prospective donors about new or multiple sexual partners in the past three months
- Asking prospective donors who reported having a new sexual partner or more than one sexual partner in the past three months about history of anal sex in the past three months
- Deferring those who report having a new sexual partner or more than one sexual partner and have had anal sex in the past three months from donating
- Allowing prospective donors who do not report having new or multiple sexual partners, and anal sex in the past three months, to be eligible to donate providing they meet all other eligibility criteria
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.”