Lifetime Ban - No Change in Rules Yet

FDA Publishes Draft Guidance to End Lifetime Ban - No Change in Rules Yet

12 May

FDA Publishes Draft Guidance to End Lifetime Ban – No Change in Rules Yet

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In May 2015, the U.S. Food and Drug Administration (FDA) announced the publication of draft guidance to end the lifetime ban on blood donation by men who have had sex with men even once since 1977. The rule was put into place in the early days of the AIDS epidemic (1983) because men who have had sex with men have a much higher prevalence of HIV/AIDS than the general population, and their blood donations increase the risk of transmission of disease to recipients of blood and blood products. As science, blood testing methods and the understanding of HIV have advanced in the past three decades, advocacy groups have called for the FDA to update its stance to be in line with current research.

The recommended change – lifting the lifetime ban, but keeping in place a donation deferral for men who have had sex with other men in the past 12 months – is consistent with the stance that Blood Centers of the Pacific and the nation’s other leading blood banking organizations have taken since 2000. This deferral period aligns with that of deferrals for other behaviors that increase risk for HIV infection.

There are two reasons to recommend this change. First, we know much more about HIV today than when FDA issued its original guidance. HIV, the virus that causes AIDS, was discovered in 1984, and tests became available in 1985. We now know how long the window period is – that time between infection and a positive test result.  Second, the introduction of nucleic acid amplification testing (NAT) has dramatically reduced that “window” period to 11 days.

Blood Centers of the Pacific is affiliated with Blood Systems Research Institute which is leading several studies to generate additional data that may provide confirmation to FDA that a change in policy is safe and appropriate. Other countries, including Australia and the UK have made changes in their deferral policies.

In May 2015, FDA issued draft guidance, with the opportunity for public comment. It is not yet known when the guidance will become final and blood centers can begin revising procedures to implement the change.

To make your views known on this issue, contact the FDA’s Center for Biologics Evaluation and Research toll free at 1 (800) 835-4709. Or write to:
Office of Communications
CBER/OCTMA (HFM-40)
Food and Drug Administration
1401 Rockville Pike, Suite 200 North
Rockville, MD 20852

For FDA’s draft guidance document go to:
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf