FDA announced last month that it will overturn a rule that bans men who have had sex with men (MSM) from donating blood.
Background on FDA rules
For more than three decades, FDA has banned blood donations from men who have sex with men, a rule originally intended to protect the blood supply from the little-understood HIV/AIDS epidemic. At the time, there was no good test to identify HIV in donated blood. As a result, any man who says he has had sex with another man at any point since 1977 is prohibited from donating blood.
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In 2013, an HHS advisory committee heard several research presentations on whether to lift the ban. In November 2014, the HHS panel voted to allow MSM to donate blood if they have not engaged in sexual activity with another man for at least one year.
Details of policy reversal
FDA said it will release proposed guidelines that allow MSM who have not had sex with a man in the past 12 months to donate blood. The agency noted that the 12-month minimum was needed to ensure the blood supply will remain safe.
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FDA officials wrote in remarks that "compelling scientific evidence is not available at this time to support a change to a deferral period less than one year while still ensuring the safety of the blood supply." Peter Marks, deputy director of FDA's Center for Biologics Evaluation and Research, said FDA will draft the new policy in early 2015 and release it for a public comment period. The guidelines will then be revised. He did not indicate whether the policy would go into effect in 2015.
According to researchers, the proposal could increase the U.S. blood supply by 2% (Tavernise, New York Times, 12/23/14; Zauzmer, Washington Post, 12/23/14; Eischen, Politico, 12/23/14).
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