FDA proposes individual risk assessments for blood donors, opening up opportunities for more men who have sex with men to donate | CNN


The US Food and Drug Administration is proposing to move to a blood donation policy that focuses on individual risk instead of relying on blanket assessments, the agency said on Friday.

The proposed guidelines eliminate time-based deferrals for men who have sex with men (MSM) and women who have sex with men who have sex with men. Instead, the guidelines propose asking all prospective donors about new or multiple sexual partners in the past three months.

Potential donors who recently had a new sexual partner or multiple sexual partners would be asked if they have had anal intercourse during that time period. Those who have not would be allowed to donate blood.

The changes would allow more blood donations among men who have sex with men. The current policy requires men who have sex with men to wait three months after sexual contact with other men before they can donate blood.

Under the proposal, those who tested positive for HIV or have HIV risk factors would be deferred from donating blood and blood banks would continue to be required to test all blood donations for 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,” FDA Commissioner Dr. Robert Califf said in a news release.

The FDA’s draft guidance is open for public comment for 60 days before the agency finalizes the guidance.

CNN first reported the FDA was considering this shift in November.

The UK overturned a similar policy in 2020, permitting MSM in long-term relationships to give blood at any time.

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