FDA proposes to ease blood donation policy for gay, bisexual men

The FDA has proposed a change to its blood donation policy from time-based deferrals for men who have sex with men to “gender-inclusive, individual risk-based” assessments to protect the blood supply from HIV, the agency announced Friday.

The proposal aligns with policies in other countries, including the United Kingdom and Canada, according to an FDA press release.

“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,” FDA Commissioner Robert M. Califf, MD, said in the release.

For years, the FDA banned MSM from donating blood due to concerns about transfusion-transmitted HIV, a ruling many experts disagreed with. The FDA revised its policy in 2015, allowing MSM to donate if their most recent sexual contact occurred at least 1 year ago. More recently, in 2020, the FDA reduced the deferral policy from 12 months to 3 months to help maintain the blood supply during the COVID-19 pandemic.

The draft recommendations would eliminate time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM, according to the FDA. The donor questionnaire would be revised to ask prospective donors if they had new or multiple sexual partners in the past 3 months. If the answer is yes, the donors would then be asked if they had anal sex during that period. If so, they would be deferred.

Any donor who did not have new or multiple sexual partners and anal sex in the last 3 months may be eligible to donate.

The FDA also proposed:

• no change in deferral time periods for donors with other HIV risk factors, including those who have exchanged sex for money or drugs or have a history of nonprescription injection drug use;
• any individual who has had a positive HIV test or has taken medication for HIV “would be continued to be deferred permanently”; and
• blood establishments would still need to test all blood donations for evidence of certain viruses such as HIV, hepatitis B and hepatitis C.

Additionally, the FDA would defer donors taking oral pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) to prevent HIV for 3 months from their most recent dose. Meanwhile, individuals who use injectable PrEP for HIV prevention would be deferred for 2 years from their most recent injection. According to the FDA, the use of PrEP and PEP may delay detection of HIV in blood donations, “potentially resulting in false negative results.”

The FDA acknowledged that while the recommendations may increase eligible blood donors, some will still be deferred.

“However, this does not mean that individuals taking PrEP should stop taking these medications to donate blood,” the release said.

Ensuring a consistent blood supply has become critical, with donations decreasing during the COVID-19 pandemic. Last year, the American Red Cross declared a national blood crisis for the first time.

The HIV Medicine Association (HIVMA) applauded the FDA’s proposal, and Chair Michelle S. Cespedes, MD, MS, welcomed guidance that “better reflects the latest advances in blood testing technology and scientific knowledge of HIV transmission risk.”

“For nearly 2 decades, HIVMA has been calling on the FDA to move to deferrals based on individual risk assessment rather than a broad exclusion of an entire community,” Cespedes said in a statement. “This is an important step towards ending the longstanding discriminatory ban on blood donations from men who have sex with men and still ensures the safety of our nation’s blood supply.”

The FDA said that its proposal will be open for public comment for 60 days. It will then review all comments before finalizing the guidance.

References:

• HIVMA applauds FDA’s new blood donor guidelines. https://www.hivma.org/news_and_publications/hivma_news_releases/2023/hivma-applauds-fdas-new-blood-donor-guidelines/. Published Jan. 27, 2023. Accessed Jan. 27, 2023.
• FDA proposes individual risk assessment for blood donations, while continuing to safeguard U.S. blood supply. https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply. Published Jan. 27, 2023. Accessed Jan. 27, 2023.