Letter from Dept of Health & Human Services FDA s
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February 28, 2013
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Mr. Rafael E. Granado
Office of the City Clerk
City of Miami Beach
1700 Convention Center Drive
Miami Beach, Florida 33139
Dear Mr. Granado: a
Thank you for forwarding a copy of Miami Beach Resolution 2013-28128, calling upon the
United States Food and Drug Administration (FDA) to reverse its policy on blood donor
deferral of men who have had sex with other men (MSM). We appreciate your interest in this
important matter.
The primary responsibility of FDA is to ensure the safety of blood and blood products for
patients who require these products. Our blood donor deferral policies are based on scientific
data that demonstrate that certain medical, behavioral, and geographical factors are
associated with an increased risk of transfusion transmitted diseases, such as HIV, hepatitis
B and C, and variant Creutzfeldt Jakob disease.
We understand that there are different viewpoints on how best to maintain the safety of the
blood supply. FDA continues to monitor and evaluate our blood donor deferral policies,
including the MSM deferral. Alternative strategies that maintain blood safety may be
considered as new scientific data become available.
On June 10-111 2010, the U.S. Department of Health and Human Services (HHS) Advisory
Committee on Blood Safety and Availability (ACBSA) met to discuss the current FDA deferral
policy on men having sex with other men (MSM). The ACBSA found that currently available
scientific data are inadequate to support a change to a specific alternative policy; therefore,
until further evaluation, the committee recommended that the current indefinite deferral for
men who have had sex with another man even one time since 1977 not be changed at the
present time.
ACBSA heard a wide range of scientific and ethical presentations on this deferral policy at the
meeting, and while they recommended retaining the current policy, they were unanimous in
finding that the current donor deferral policies, including those directed at MSM donors, are
suboptimal, and recommended behavioral and epidemiological studies to support future
policy reconsiderations. In response, the Assistant Secretary for Health (ASH) established a
working group with representatives from FDA, CDC, CMS, HRSA and NIH to define research
pathways that will be responsive to the ACBSA recommendations.
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For more information about the HHS ACBSA meeting and follow-up actions, please view the
following website:
http://www.hhs.gov/ash/bloodsafety/advisorycorrimittee/recommendations/resolutions.htmI
Sincerely,
XOV-"4
Laura Carter
Consumer Safety Officer
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
This informal communication represents my best judgment at this time. It does not constitute
an advisory opinion in accordance with 21 CFR 10.85, and does not necessarily represent
the formal position of FDA or otherwise obligate the agency to the views expressed.
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