Posts Tagged As: FDA

Will the FDA Gay Blood Ban Finally Go Away?

Jim Burroway

July 26th, 2016

The Food and Drug Administration has posted a request for public comment on possible changes to the FDA’s current policy barring gay men from donating blood unless they have been sexually abstinent for a full year. According to the notice, the FDA appears ready to consider changing that policy (PDF: 321KB/7 pages):

Interested persons are invited to submit comments, supported by scientific evidence such as data from research, regarding potential blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options. FDA will take the comments received into account as it continues to reevaluate and update blood donor deferral policies as new scientific information becomes available.

Before last December, it had been FDA policy to permanently ban all men who had ever had sex with another man. That policy was updated to limit that ban to men who had sex with other men in the last twelve months, which, it said, was “better align[ed] the deferral period for MSM with the deferral period for other men and women at increased risk for HIV infection, such as those who had a recent blood transfusion or who have been accidentally exposed to the blood of another individual through a needle stick.”

According to this latest request for comment, the FDA is now considering proposals that would “move from a time- based deferral period to a deferral policy based on individual risk assessment. An individual risk assessment would involve asking potential donors a series of questions designed to defer donors with high risk behaviors.” The request sought comment on what kinds of questions to ask, how specific should they be and still be “understandable and acceptable to all blood donors” while also ensuring donors will answer them accurately, and what other procedural changes might be necessary to ensure the risk assessments are being performed. The notice also requests input for the design of a potential study “to evaluate the feasibility and effectiveness of alternative deferral options such as individual risk assessment.”

The comment period closes 120 days from now.

FDA to reconsider blood donation ban

Timothy Kincaid

March 13th, 2010

From the LA Times:

Federal health officials announced Friday that they would reexamine a 27-year-old set of restrictions on blood donations by gay men.

The FDA “has been actively engaged in reexamining the issue of blood donor deferral for men who have had sex with other men, taking into account the current body of scientific information, and we are considering the possibility of pursuing alternative strategies that maintain blood safety,” the agency said in a statement.

The issue will be examined by the Department of Health and Human Services’ blood safety committee in June, according to the statement.


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