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

Originally Published: 27 JAN 23 10:39 ET

Updated: 27 JAN 23 12:06 ET

By Carma Hassan, CNN

 (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.

"Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the safety or the availability of the US blood supply. Our approach to this work has always been, and will continue to be, based on the best available science," FDA Commissioner Dr. Robert Califf said at a news conference on Friday.

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.

People taking HIV-prevention drugs will still have to undergo a deferral period under the proposed guidance.

For people taking HIV-prevention pills, known as PrEP or PEP, they must wait three months from their most recent dose, while those taking injectable PrEP drugs must wait two years.

"This is simply a matter of following the data that we have at this time, which is that we know that people who take PrEP -- at least, at this point with our knowledge of PrEP -- that if you look at the population overall taking PrEP, there's a certain risk currently of contracting HIV," Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said at the news conference.

"So, until we can better sort out who is of lower risk in that group taking PrEP, we need to put this donor deferral in place for PrEP. That's not to say that we won't continue to look at this and try to refine things further. It's just that ultimately, as we move forward, we have to maintain the current safety of the blood supply and moving forward as we're doing now, this may not be the final resting place of where we end up but it allows us to move forward and to at least make a leap forward to allow some men who are not taking PrEP to donate."

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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