The U.S. Food and Drug Administration (FDA) announced on Tuesday that it is proposing a change in the way it assesses blood donor eligibility to reduce the risk of transfusion-transmitted HIV.
In the 1980s, the FDA reversed the blanket lifetime donation ban on men who have sex with men to time-based abstinence of at least a year before donating. It was shortened to 3 months in 2020 at the peak of the Covid pandemic due to the shortage of blood supply.
The agency now plans to shift away from time-based deferrals and instead use what it called “gender-inclusive, individual risk-based questions”. The proposal, it said, is in line with policies that are already in place in countries like the United Kingdom and Canada.
The new proposed guidance would eliminate time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM. 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. All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.
FDA Commissioner Robert M. Califf, M.D. stated, “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 proposal also includes no change in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use. Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently. Blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.
The FDA also proposed guidance related to pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP). Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose. Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection.
The FDA will now open the proposal for public comment for 60 days. The agency 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.