The U.S. Food and Drug Administration (FDA) on Friday proposed 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.
The proposed guidance includes the following draft recommendations:
- Time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.
- 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.
- Prospective donors who report having a new sexual partner or more than one sexual partner and having anal sex in the past three months would be deferred from donation.
- Under this proposal, a prospective donor who does not report having new or multiple sexual partners and anal sex in the past three months may be eligible to donate, provided all other eligibility criteria are met.
The agency noted its proposal aligns with policies in place in countries such as the U.K. and Canada.
“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,” Dr. Robert Califf, FDA commissioner, said in a statement. “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.”
The FDA said it recognizes that the draft recommendations could increase the number of individuals eligible to donate blood and that some individuals will be deferred from donating blood.