Reducing the risk of transfusion-transmitted HIV from blood donations is important for public health and the U.S. currently uses time-based deferrals to assess donor eligibility. Now the FDA is proposing individual risk-based questions to reduce the risk of transfusion-transmitted HIV similar to policies in place in countries like the United Kingdom and Canada.

Blood donations are important and FDA believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply. The new draft recommendations are based on data from other countries with similar HIV epidemiology that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply.

Under the new proposed guidance:

The 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.

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.

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.

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.

“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,” said FDA Commissioner Robert M. Califf, M.D. in a statement.