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Rainbow Alliance
Student Organization
Saint Norbert College
100 Grant Street, Suite #1262
De Pere, WI 54115
Leslie Kux
Associate Commissioner for Policy
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. FDA-2016-N-1502 [Blood Donor Deferral Policy for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products; Establishment of Public
Docket; Request for Comments.]
Dear Associate Commissioner Kux,
This letter is written in support of ending the Men who have Sex with Men (MSM) one year deferment
under the current Food and Drug Administration policy. This policy is a step in the right direction thanks
to the amendments on the previous lifetime ban, but the practice is still rooted in prejudice. While it is
true that a large portion of new AIDS/HIV cases in the United States are from the MSM population, using
a blanket ban on all MSM prevents many healthy men from donating. This only exacerbates the prevalent
blood shortages that the American Red Cross struggles with. Instead, the FDA should move toward
creating an individual risk assessment that can be administered to all people to judge risk behaviors,
rather than targeting a single population.
HIV testing has improved since the first generation tests developed in 1983. While there was initially a
window-period of 6-12 weeks post infection with these first generation tests, fourth and fifth generation
testing has reduced this to 11-14 days by adding p24 antigen detection to their screening assay
(Alexander, 2016). In addition to personal pre-testing, all donated blood is tested for HIV so this
improved testing also benefits ruling out any HIV infected blood after been donated. This limited window
of possible negative results, along with an increased accuracy of testing for HIV, reduces the need of
MSM deferral. Instead, MSM could present negative testing results along with answering a risk
assessment of behavior between the period of testing and the donation. This would provide the necessary
screening to maintain the safety of the blood supply.
Individual risk assessment was the FDAs solution to a similar act of prejudice in 1990 when confronted
about the Haitian blood ban. Haitians were found to have a higher rate of HIV and their blood was banned
from being donated. However, the FDA moved to additional testing before and after donating blood and
modified screening questions (Berkman & Zhou, 2015). Increased screening questions that target
practices which are considered risk factors unprotected anal and oral sex, exposure to blood, engaging
with multiple sexual partners, and intravenous drug use not only for MSM, but for all donors, would
increase the safety of the blood supply. Rather than targeting a group of individuals who may or may not
participate in any of those activities, increased screening would prevent discrimination while showing a
commitment to safety.
It has been acknowledged by your department that there are many non-compliant MSM that donate blood
and that these donations make up an estimated 2.6% of male blood donors (United States Food and Drug
Administration, 2015, p. 5). These men are passionate about helping their communities by providing
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blood donations and, although morally questionable, have chosen to lie about their sexual history in order
to serve their communities. It was found that out of MSM who donate blood only 0.25% had HIV
compared to the estimated 11-12% of the MSM population, which shows that MSM who look to give
blood often practice self-selection in determining their participation (United States Food and Drug
Administration 2015, p.6).
Combining the demonstrated self-selection along with generalized self-assessment questionnaires for all
persons donating blood as well as improved HIV testing shows that the MSM blood ban is not necessary.
Instead, your department could increase the number of blood donations, improve the safety of the blood
pool and show a commitment to supporting all people regardless of sexual orientation. The current ban
not only disallows a large portion of possible donors, but shows a clear prejudice against MSM when
risky behaviors in heterosexuals do not limit their donations. A change is necessary, and your department
is the only one that can save countless lives in this country, lives that depend on the blood given willingly
by citizens. We hope that you do the right thing and lift this ban, replacing it with risk-assessment
questionnaires and providing the ability for those with proof of negative HIV status to donate.
Sincerely,

Broderick Lemke Rose Gilderson-Duwe

President of Rainbow Alliance Vice President of Rainbow Alliance

Kirstin Duprey Jenny Patton

Treasurer of Rainbow Alliance Secretary of Rainbow Alliance

Stephen Rupsch
Faculty Advisor of Rainbow Alliance

The following Rainbow Alliance Members and Saint Norbert College Community Allies:

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Citations:
Alexander, T. S. (2016). Human immunodeficiency virus diagnostic testing: 30 years of evolution.
Clinical and Vaccine Immunology 23:249253. doi:10.1128/CVI.00053-16.
Berkman, R.T., & Zhou, L. (2015). Ban the ban: A scientific and cultural analysis of the FDAs ban on
blood donations from men who have sex with men. Columbia Medical Review, 1(1), 2-9. doi:
10.7916/D8HX1BST
United States Food and Drug Administration (2015, December 21). Revised recommendations for
reducing the risk of human immunodeficiency virus transmission by blood and blood products - Questions
and answers.