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FDA Revises Mandate Against Blood Donations From Gay Men

via Pixabay

The Food and Drug Administration (FDA) has changed its policy which banned blood donation centers from accepting blood donations from men who have had sexual intercourse with other men.

The FDA made the announcement on Monday, stating that after many years of scientific research and guidance from external advisory teams and government agencies, it has revised its policy to allow homosexual and bisexual males to donate blood as long as a period of twelve months has passed since the latest sexual encounter with another man.

The lifetime deferment of blood donations from gay and bisexual men was put in place by the FDA in 1983, when the AIDS crisis had just begun and little information was available about the transmission of the disease. This is the first time that the FDA has changed its recommendations regarding the reduction of the risk of transmitting HIV through blood and blood products since 1992.

According to the administration’s website, they have consistently been checking their donor deferral recommendations with the intent of reducing the risk of HIV transmission over the past ten years, via public meetings of the FDA Blood Products Advisory Committee and the HHS Advisory Committee for Blood Safety and Availability(ACBSA). The recent change was prompted specifically by the ACBSA’s observation that the policy which was in place for males who have had sex with other males (MSM) was deficient and needed to be subjected to studies that might promote a potentially better policy.

We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.

These studies were conducted, and after they were assessed by several Public Health Service organizations including the Centers for Disease Control and Prevention, Health Resource and Services Administration, National Institutes of Health and the Office of the Assistant Secretary for Health, the results were presented to the HHS Advisory Committee for Blood and Tissue Safety and Availability (the ACBSA’s successor) in November 2014. In turn, it was recommended that a shorter deferral period would be appropriate.

The Human Rights Campaign has called this change a “step in the right direction,” although it “still falls short of a fully acceptable solution because it continues to stigmatize gay and bisexual men.” In response, Dr. Peter Marks, who is the deputy director of the FDA’s center for Biologics Evaluation and Research, stated that the requirement for MSM to be celibate for a year in order to donate blood is in fact supported by scientific evidence which is relevant to the public health safety of the United States population.

The FDA has also changed its deferral recommendation for those who suffer from hemophilia and similar blood clotting disorders due to the improved safety measures that are currently being used in the production of clotting factor concentrates. Other behavior related deferrals, such as those placed on commercial sex workers and injection drug use remain the same, as insufficient data has been found to support a change to the existing recommendations at this time. In addition, the FDA recommends that transgender individuals self-identify on the provided donor history questionnaire.

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