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Regulatory News | 21 December 2015 | By Michael Mezher
The US Food and Drug Administration (FDA) finalized guidance Monday that would end the agency's policy of indefinitely deferring gay and bisexual men, or men who have sex with men (MSM), from donating blood.
Since 1983, FDA has recommended an indefinite deferral for MSM in order to reduce the risk of human immunodeficiency virus (HIV).
In recent years, FDA and the Department of Health and Human Services (HHS) have been considering how to revise the policy in light of new scientific evidence. At the same time, FDA has faced public pressure to change its policies, with medical groups such as the American Medical Association (AMA), American Red Cross and the American Association of Blood Banks calling for the ban to be lifted.
In December 2014, FDA announced it would be ending its policy of a lifetime ban in favor of a 12-month deferral period. Then, in May 2015, FDA released its draft guidance, Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.
At the time, critics argued that even a 12-month deferral period was unwarranted, as modern diagnostics can detect HIV in as little as 10 days.
Now, MSM are eligible to donate blood if they wait 12 months after having sex with another man.
The guidance also recommends for gender identity to be self-reported by donors, and removes a clause that appeared in the draft version that would have allowed medical directors to "exercise discretion" for donors that "asserted a change in gender identification."
In a press briefing today, Peter Marks, deputy director of the Center for Biologics Evaluation and Research (CBER), said the agency has "taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply."
In making the case for the 12-month deferral, Marks pointed to other countries with comparable HIV demographics, such as the UK and Australia, which currently use such a deferral period.
Marks said in a call with reporters the agency considered several options before deciding on a 12-month deferral, including eliminating the deferral altogether or relying on individual risk assessments to screen donors for HIV transmission risk. He added that eliminating the deferral altogether would be untenable, as HIV diagnostics "are not perfect" and HIV can go undetected in patients for a short time after infection.
Marks said countries such as South Africa and Italy, which use individual risk assessments, have higher rates of HIV in heterosexual populations and rely on trained physicians to conduct the risk assessment, making a comparison to the US difficult.
Marks also said FDA received more than 700 comments on the guidance from groups or individuals, with about half supporting either a time-based deferral or individual donor risk-assessments, and half still in support of an indefinite ban.
FDA Press Release, Q&A, Guidance