FDA Issues Draft Recommendation for Updated Blood Donation Guidelines

On January 27, 2023, the FDA issued a press release linking its new draft recommendation for updated blood donation guidelines. These updated guidelines take a more modern and individual approach to blood donations, echoing the actions of multiple other developed nations, such as the United Kingdom and Canada.

Historically, the United States blood donation system has discriminated against multiple blood populations based on gender identity and sexuality under the guise of creating a safe blood supply. Early restrictions prevented gay and bisexual men from donating blood altogether. Decades later, that guideline was altered to allow gay and bisexual men abstinent for one year to donate blood.

However, as other countries have altered their blood donation standards while maintaining safety standards, the US still needs to catch up. The newest draft recommendation by the FDA may help rectify this, expanding eligibility for blood donation.

According to the organization’s press release, the recommendation focuses on conducting more individual blood assessments rather than refusing to accept donations based on gender or sexual identity. As part of the recommendation, the time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM will be adjusted.

Instead, the donor history questionnaire will ask all prospective donors about sexual partners in the three months before the donation. Additional recommendations include additional screenings for those who have had new or multiple sexual partners in the given time frame. The guidelines advise that anyone having anal sex with new or multiple sexual partners in the past three months be deferred. Assuming all other eligibility criteria are met, donors who have not had anal sex in the past three months are allowed to donate.

Despite those changes, the FDA is recommending the continued deferral of donations from sex workers, those who use injectable non-prescription drugs, those who tested positive for HIV, and anyone who has taken medication to treat HIV. Furthermore, all blood donations should still be tested for transfusion-transmitted infections.

The updated guidelines have also considered pre- and post-exposure prophylaxis, recommending a three-month deferral after oral medications and a two-year deferral after injectable medications.

“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,” said FDA Commissioner Robert M. Califf, MD, in the press release. “Maintaining a safe and adequate supply of blood and blood products in the US 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.”