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Regulatory Focus™ > News Articles > FDA to Reevaluate Gay Blood Donor Guidance

FDA to Reevaluate Gay Blood Donor Guidance

Posted 26 July 2016 | By Michael Mezher 

FDA to Reevaluate Gay Blood Donor Guidance

The US Food and Drug Administration (FDA) on Tuesday called for public input on its December 2015 guidance that ended the agency's indefinite ban on gay men donating blood in favor of a 12-month deferral since the donor last had sex with another man.

Specifically, FDA says its goal is to gather information and evidence that could support alternatives to the 12-month deferral period as the agency reevaluates its policy.

Recent events such as the mass shooting at a nightclub in Orlando that left 50 people dead and 53 wounded have renewed calls for FDA to remove restrictions on gay men from donating blood.

Just days after the shooting, 116 members of congress wrote to FDA Commissioner Robert Califf calling on the agency to end the restrictions in favor of a an individual risk assessment that would reflect "risk-based behaviors as opposed to sexual orientation."


Since the 1980s, FDA has recommended an indefinite deferral for gay and bisexual men, referred to as men who have sex with men (MSM), from donating blood in order to reduce the transmission of human immunodeficiency virus (HIV).

When FDA first announced it would end the lifetime ban in favor of a 12-month deferral period in 2014, critics lashed out at the agency saying that even a 12-month deferral period was excessive in light of recent advances in diagnostics that allow for HIV to be detected in a patient's blood in as little as 10 days.

In response, Center for Biologics Evaluation and Research (CBER) deputy director Peter Marks defended the new guidelines, saying the agency had "taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply."

Reevaluation: Alternatives to Time-Based Deferrals

Now, FDA says it wants to see scientific data on alternatives to the 12-month deferral, such as individual risk assessments, similar to what are used in countries such as South Africa and Italy to identify risky donors. The agency says this input will be used to help the agency reevaluate the policy "as new scientific information becomes available."

However, FDA says that any changes to its policy "must be data-driven" and that it could not specify when any future changes might occur.

"We invite interested persons to submit to the docket comments supported by scientific evidence regarding possible revisions to FDA's blood donor deferral policies … FDA requests that commenters provide scientific evidence, such as data from research to evaluate the feasibility or effectiveness of such alternative deferral policy options," the agency writes.

FDA also asks for input on a series of questions, such as "What questions would most effectively identify individuals at risk of transmitting HIV through blood donation?" and "How specific can the questions be regarding sexual practice while remaining understandable and acceptable to all blood donors?"


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