Overturning a ban that has been in place for 3 decades, the FDA have declared that Gay men can now donate blood, as long as they have not had gay sex in the last one year.
The earlier deferral policy, which entirely prohibited men who have sex with men (MSM) from donating blood, has been a source of debate in the past with gay rights organizations, who have termed the policy discriminatory.
A statement by the FDA notices that their decision happens after a extensive review of their guidelines concerning human immunodeficiency virus (HIV) transmission via blood products.
FDA’s acting commissioner states that
The FDA’s duty is to manage a high level of blood product safety for individuals whose lives rely on it. We have taken good care to make sure this policy revision is supported by sound science and continues to secure our blood supply.
With respect to the FDA, by pursuing the best accessible science – along with donor education materials, deferral concerns and advances in HIV donor examining – they have been able to decrease the HIV transmission rates from blood transfusion from 1 in 2,500 to 1 in 1.47 million.
Study outcomes lead to deferral policy revisions
Throughout the past 1 decade, the FDA have revisited their donor deferral suggestions various times, especially as they associate to decreasing HIV transmission risk.
In 2010, the Advisory Committee for Blood Safety and Availability (ACBSA) identified that the deferral policy for MSM required to be revisited.
As such, researches were performed to better inform a possible policy change, and in 2014, the FDA, Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) – together with other Public Health Service organizations – evaluated the research outcomes.
Then, in November 2014, the outcomes were provided to the appropriate committees; after evaluating the outcomes, it was suggested that a shorter deferral interval was more appropriate.
The FDA note that donor testing performs a pivotal role in keeping the US blood supply safe. Donors should be free from any condition that is transmissible by blood transfusion, which is identified by health history and examination.
Additionally, donors are advised about risks and must answer questions pertaining to their blood safety; donors with a record of intravenous drug abuse are deferred.
FDA will ‘perform ongoing research in this area’
Representatives from the FDA say their modified suggestions mean that the deferral interval for MSM is more in line with that for other men and women who are at enhanced HIV risk, for instance, those who have had a recent blood transfusion or have been unintentionally exposed to another person’s blood.
The US is not the initial nation to modify their blood donor suggestions; other nations, such as the UK and Australia, have put in place 12-month deferrals for MSM.
Actually, while in Australia’s shift to a 12-month deferral for MSM, health authorities in the nation performed studies that analyzed over 8 million units of donated blood and identified that there was no change in risk to the blood supply with the new deferral system.
The new guidance also indicates that blood establishments make modifications to their donor education materials, questionnaires and accompanying materials, along with to their product management procedures.
Leaving comments on their modified deferral policy, Dr. Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research, states that:
“In examining our policies to assist decrease the risk of HIV transmission via blood products, we carefully analyzed several substitute choices, which includes individual risk evaluation. Finally, the 12-month deferral window is supported by the best accessible scientific proof, at this point in time, appropriate to the US population.”
He adds that the FDA will “keep on actively performing studies in this area and further revise our policies as new data arise.”