BILL ANALYSIS �
AJR 50
Page 1
Date of Hearing: August 19, 2014
ASSEMBLY COMMITTEE ON JUDICIARY
Bob Wieckowski, Chair
AJR 50 (Bloom) - As Introduced: August 5, 2014
As Proposed to be Amended
SUBJECT : BLOOD DONATION
KEY ISSUE : SHOULD THE FEDERAL GOVERNMENT BE URGED TO ADOPT
SCIENCE-BASED POLICIES THAT REPEAL THE CURRENT DONOR SUITABILITY
AND DEFERRAL POLICIES OF THE FOOD AND DRUG ADMINISTRATION
PROHIBITING BLOOD DONATION BY MEN WHO HAVE HAD SEX WITH MEN?
SYNOPSIS
This measure, sponsored by Equality California, urges the
President and the Department of Health and Human Services to
adopt science-based policies that repeal the Food & Drug
Administration's donor deferral policy that essentially
prohibits blood donation by men who have had sex with men (MSM)
at any time since 1977. The current FDA policy has remained in
effect since articulated in a 1992 guidance document, despite
recent instances where FDA invited the submission of scientific
evidence in its reconsideration of the policy. The FDA and
proponents of that policy contend that because HIV is more
prevalent in MSM than in other groups, the policy is still
necessary to protect public health and the nation's blood
supply. On the other hand, opponents of the policy, including
the American Medical Association and three major blood
collection agencies, believe these concerns are medically and
scientifically unwarranted, given that all blood is now
laboratory tested for HIV. Evidence submitted by the blood
collection agencies of recent advances in laboratory testing and
donor screening techniques has not yet persuaded the FDA to
change its policy. Supporters of this resolution also believe
it is irrational for the FDA to broadly differentiate sexual
transmission via male-to-male sexual activity from that via
heterosexual activity, and they contend that current donor
screening procedures should be revised to treat potential donors
of similar risk history alike, rather than on the basis of
sexual orientation. In addition to updating FDA policy to
reflect newer scientific evidence, proponents believe that
removing the broad prohibition on blood donation by MSM will
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prevent unjustified stigma largely directed towards gay men and
will resolve any conflict between the policy and state
anti-discrimination law. There is no known opposition to this
measure.
SUMMARY : Requests the President and the Department of Health
and Human Services to adopt science-based policies that repeal
current Food and Drug Administration policies that prohibit men
who have had sex with men from donating blood. Specifically,
this resolution :
1)Declares that California law prohibits discrimination against
individuals on the basis of actual or perceived sex, sexual
orientation, gender identity, and gender-related appearance
and behavior.
2)Finds that current Food & Drug Administration (FDA) policy
effectively prohibits any man who has had sex with another man
even one time since 1977 from donating blood for the rest of
his life, and that the FDA essentially classifies all sexually
active gay and bisexual men in the highest-risk blood donor
category, the same category as IV drug users and people who
have spent more than five years since 1980 in a country that
has mad cow disease.
3)Declares that the American Red Cross (ARC), the American
Association for Blood Banks (AABB), and America's Blood
Centers (ABC), at a 2006 workshop convened by the FDA, issued
a joint statement that they believe the current blood donation
policy of lifetime deferral for men who have had sex with men
is medically and scientifically unwarranted, and calling for
deferral criteria to be made comparable with criteria for
other groups at increased risk for sexual transmission of
infections that can be transmitted through blood transfusion.
4)Asserts that it does not appear rational to broadly
differentiate sexual transmission via responsible male-to-male
sexual activity from transmission via responsible heterosexual
activity on scientific grounds, and that to many, this
differentiation is unfair, creates stigma without any
justifiable public health imperative, and fosters negative
attitudes towards blood collection facilities and the
eligibility criteria they use to screen donors.
5)States that blood banks routinely operate with a short supply,
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and that, according to the AABB, ABC, and ARC, some regions
have operated with less than two days' supply of blood
following significant emergencies or natural disasters.
6)Finds that many men who have sex with men are healthy, present
no risk of introducing HIV or other infectious agents into the
nation's blood supply, and wish to be blood donors without
compromising the safety or reliability of the blood supply.
7)Finds that blood collection agencies are both willing to
collect data to evaluate the impact of changes in the FDA
deferral policy, and to facilitate informed policymaking and
development of appropriate interventions to ameliorate any
impact.
8)Declares that federal advisory committees have encouraged the
FDA to further develop new technologies, including nucleic
acid testing (NAT) and pathogen inactivation, that hold
promise to substantially reduce the risk that blood from any
donor containing a transfusion transmissible infection could
be introduced into the blood supply.
9)States that FDA guidelines followed by blood banks throughout
the country inadvertently create unjustified stigma directed
towards men who have had sex with other men, and that these
guidelines conflict with state nondiscrimination policies.
10)Calls upon the President to encourage, and the Secretary of
the U.S. Department of Health and Human Services to adopt,
policies that repeal current donor suitability and deferral
policies of the FDA prohibiting blood donation by men who have
had sex with men, and instead direct the FDA to develop
science-based policies.
EXISTING LAW :
1)Pursuant to Food & Drug Administration blood donation policies
regarding screening and deferral of potential donors:
a) Requires that potential donors are informed about the
risk of transmitting infectious diseases through blood
donation.
b) Requires potential donors to be asked screening
questions about their health status, health behaviors, and
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other factors that are associated with an increased risk of
being infected with transmissible disease, in order to help
persons identify themselves as potentially at higher risk
for transmitting infectious diseases and defer from
donating on their own accord, rather than unknowingly
donating blood that may be infected.
c) Requires that the minimum information presented to
potential donors at every visit indicate clearly that
persons meeting certain criteria should not donate blood,
including, but not limited to, men who have had sex with
other men even one time since 1977.
d) Prohibits blood donation establishments from allowing
men who have had sex with other men even one time since
1977 to donate blood, even when such a donor does not wish
to self-defer. ("Revised Recommendations for the
Prevention of Human Immunodeficiency Virus Transmission by
Blood and Blood Products", Food & Drug Administration
guidance document, April 23, 1992.)
2)Pursuant to the Unruh Civil Rights Act, provides that all
persons within the jurisdiction of this state are free and
equal, and specifically prohibits discrimination based on sex,
race, color, religion, ancestry, national origin, disability,
medical condition, marital status, or sexual orientation with
respect to accommodations, advantages, facilities, privileges,
or services in all business establishments of every kind.
(Civil Code Section 51.)
FISCAL EFFECT : As currently in print this measure is keyed
non-fiscal.
COMMENTS : This resolution, sponsored by Equality California,
respectfully requests the President and the Department of Health
and Human Services to adopt policies that repeal current Food
and Drug Administration policies that prohibit men who have had
sex with men from donating blood. The author believes that the
current FDA policy is unnecessary given improvements in donor
screening techniques, and operates in an unfair and
discriminatory manner against homosexual men as a group because
of their status, without regard to whether screening of
individual donors indicates any risk of transmitting disease via
blood transfusion.
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Author's statement: According to the author:
Under current FDA policies, men who have sex with other
men are prohibited from donating blood. This is an
outdated and discriminatory policy that should be
replaced scientific evidence-based practices for
collecting and testing donated blood.
In 1983, the federal Food and Drug Administration (FDA)
placed a prohibition on blood donation by men who have
had sex with another man even one time since 1977. At the
time, the FDA had no way of testing blood or plasma for
HIV and, having classified gay and bisexual men as
high-risk blood donors, eliminated them from the donor
pool to decrease the chances of transfusion-related HIV
transmission. Many things have changed since the ban was
put in place. Access to sexual education and products to
decrease the chances of STD transmission has increased.
New laws, social practices and health care innovations
have reframed how we address and prevent HIV
transmission. Additionally, blood screening technologies
have advanced greatly since the early 1980s, HIV and
other viruses can be identified faster and cheaper than
ever before. Emerging blood screening practices, such as
Nucleic Acid Amplification Testing, could dramatically
decrease the risk of transfusion-related HIV
transmission.
Now is the time to end the outdated and discriminatory
ban on blood donation by gay and bisexual men. Risk of
public safety emergencies caused by blood shortages could
be lowered by increasing the donor pool. Screening and
deferral policies should reflect current evidence-based
science and transmission data.
Background on Blood Donation: Use of Screening Questionnaires
and Laboratory Testing. The use of screening questionnaires,
such as that used to identify and exclude MSM, is efficient in
excluding large numbers of such men from giving blood. However,
if an infected person did give blood despite the screening
questionnaire process, blood banks now test donated blood by
both serologic (antibody) testing and the more recently
developed nucleic acid test (NAT) method before the blood can be
used in a transfusion or contaminate other blood supplies. Both
methods of laboratory blood testing allow detection of
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HIV-infected donors between 10 and 21 days after exposure. This
period that occurs immediately after a person is infected, but
when blood testing may not be able to detect low levels of HIV,
is known as the critical "window period." Because blood
donations are routinely tested prior to use in any transfusion,
the danger in allowing certain high-risk groups who are more
likely to carry transmissible infections to give blood primarily
lies in the possibility of false negative laboratory testing,
and to a lesser degree in the inadvertent release of infected
blood to be used in a transfusion.
Origin of the FDA Policy. According to the FDA, men who have
had sex with other men (MSM) at any time since 1977 are deferred
as blood donors because, as a group, MSM are at increased risk
for HIV, hepatitis B, and other infections that can be
transmitted by blood transfusion. The year 1977 was chosen
because it marked the beginning of the AIDS epidemic in the
United States. Although the FDA policy uses the term
"deferral," the policy in effect acts to prohibit, in all cases,
men who have had sex with men since 1977 from donating blood.
The FDA has had a donor deferral policy for MSM since 1983, when
the risk of AIDS from transfusion was first recognized. On
April 23, 1992, the FDA issued a memorandum (also known as a
"guidance document") to all blood donation establishments titled
"Revised Recommendations for the Prevention of Human
Immunodeficiency Virus Transmission by Blood and Blood
Products." As is common in administrative law, the agency
issued this memorandum to those in the regulated community to
provide guidance and more detailed instruction on how to comply
with federal law and regulations. The specific rules in such a
memorandum can and often do have the effect of agency policy.
In this case, the current FDA policy deferring blood donation by
MSM traces back to that 1992 memorandum and has remained in
effect since that time.
Scientific Considerations Cited by the FDA in Support of Its
Current MSM Policy . According to the FDA website, the primary
responsibility of the agency is to enhance blood safety and
protect blood recipients, and its MSM deferral policy is
intended to protect all people who receive blood transfusions
from an increased risk of exposure to blood potentially infected
with certain disease-causing agents, including HIV, the virus
that causes AIDS. The FDA cites a variety of epidemiological
and scientific data to justify its current MSM deferral policy,
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including that:
(1) Men who have had sex with men since 1977 have an HIV
prevalence 60 times higher than the general population
and 800 times higher than first time blood donors;
(2) MSM account for the single largest group of blood
donors who are found HIV-positive by blood donor
testing;
(3) Even the latest blood testing technology cannot
detect very low levels of HIV present in the blood
during the short "window period" right after infection
but before HIV tests can detect the virus;
(4) Several scientific models show there would be a
small but definite increased risk to people who receive
blood transfusions if the MSM deferral policy were
changed and that preventable transfusion transmission of
HIV could occur as a result.
(5) Researchers have not yet found an alternative set of
donor eligibility criteria (even including practice of
safe sex or a low number of lifetime partners) that will
reliably identify MSM who are not at increased risk for
HIV or certain other transmissible infections.
The FDA has stated it would change its MSM deferral policy "only
if supported by scientific data showing that a change in policy
would not present a significant and preventable risk to blood
recipients."
(http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/
QuestionsaboutBlood/ucm108186.htm.)
Despite Scientific Arguments Made by Blood Collection Agencies,
the FDA Has Declined to Change its Policy . On March 8, 2006,
the FDA conducted a workshop entitled "Behavior-Based Donor
Deferrals in the Nucleic Acid Test (NAT) Era". The workshop
addressed scientific challenges, opportunities, and risk-based
donor deferral policies relevant to the protection of the blood
supply from transfusion transmissible diseases, seeking input on
this topic. Participants were given the opportunity to provide
scientific data that could support revising FDA's MSM deferral
policy.
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At that workshop, three major blood collection agencies, the
American Red Cross (ARC), the American Association for Blood
Banks (AABB), and America's Blood Centers (ABC), testified
before the FDA's Blood Products Advisory Committee. These
organizations recommended that the deferral period for MSM be
changed to 12 months since last sexual contact, which would make
this consistent with the deferral periods for other potentially
high risk sexual exposures. Except during the window period
right after infection, the agencies stated that there is no
valid scientific reason to differentiate between individuals
infected a few months or many years previously. Furthermore,
the agencies cited new evidence showing that the vast majority
of donors with prevalent HIV infection will test positive by
both serologic testing and the NAT method, thus assuring
redundancy in laboratory screening that all donated blood
undergoes. As a result, according to the agencies, the small
risk to recipients posed by false negative screening in the
laboratory is very minimal.
According to the blood collection agencies, the proper
scientific basis for FDA's policy specifying deferral periods
for certain at-risk sexual behaviors should be the length of
window periods for laboratory testing, not the initial mode or
time of HIV infection (unless the infection is so recent as to
have occurred within the critical window period.) The agencies
argue that the proper focus of the screening questions should be
on recent risk history of possible infection, particularly as
that interacts with the window period for lab testing methods,
and they point out that this is already true for many other
screening questions not related to MSMs.
Following the 2006 workshop, however, the FDA disagreed with the
scientific positions of the blood collection agencies and
declined to change its deferral policy for MSMs, stating on its
website: "Scientific evidence has not yet been provided to FDA
that shows that blood donated by MSM or a subgroup of these
potential donors, is as safe as blood from currently accepted
donors. FDA remains willing to consider new approaches to donor
screening and testing, provided those approaches assure that
blood recipients are not placed at an increased risk of HIV or
other transfusion transmitted diseases."
Current FDA Policy Treats Homosexual and Heterosexual Donors
Differently Without Regard to Individual Levels of Risk .
Supporters of this resolution have adopted the position of the
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blood collection agencies that the FDA's lifetime deferral
policy for MSMs is medically and scientifically unwarranted, and
that the FDA policy should be revised on that basis alone. The
author notes that the American Medical Association (AMA) House
of Delegates and the HIV Medicine Association (part of the
Infectious Diseases Society of America) have joined the three
major blood collection agencies in adopting the position that
scientific knowledge of HIV transmission and blood testing
methods now justifies revising the FDA deferral policy with
respect to MSM. Therefore, the resolution calls upon the
Secretary of the Department of Health and Human Services to
"adopt policies that repeal the current donor suitability
policies of the FDA regarding blood donation by men who have had
sex with another man and, instead, direct the FDA to develop
science-based policies."
Under current FDA policy, potential blood donors judged to be at
risk for exposure via heterosexual routes are deferred for only
one year, while men who have had sex with another man even once
since 1977 are permanently deferred. The author believes the
FDA is not justified in broadly differentiating sexual
transmission via male-to-male sexual activity from that via
heterosexual activity. As the measure states: "Even with a
clean bill of health, a gay man is considered more of a threat
to the blood supply than a straight man who was treated for
chlamydia, syphilis, gonorrhea, venereal warts, and genital
herpes within the past year. In 40 states, a man can even give
blood immediately following a tattoo or 12 months after having
sex with a prostitute."
Current FDA Policy May Unjustifiably Stigmatize MSM. According
to the author, not only do current FDA guidelines conflict with
state nondiscrimination policies, but they also may
"inadvertently create unjustified stigma directed towards gay,
bisexual, transgender, and heterosexual males on the basis that
they have had sex with another male since 1977." According to
Dr. Ronald Bayer of Columbia University, this threat of
stigmatization is something that has concerned gay advocates
ever since the FDA first implemented its lifetime deferral
policy for MSM in 1983. Speaking at the FDA workshop in 2006,
Bayer recounted:
Gay organizations (at the onset of the AIDS crisis) were
concerned that an explicit bar to donation by men who
had sex with men would only serve to bolster
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stigmatization and homophobia. Banning men who had sex
with men from the donor pool would exclude them from one
of the great acts of altruism in contemporary society. .
. Typical of the resistance to exclusions were comments
like these: "A ban on gay donors would be a return to
the bad old days when a recurrently scapegoated minority
could be sweepingly stigmatized for the taint of bad
blood."
In summary, supporters of the resolution believe that the FDA
deferral policy is outdated and should be changed to reflect
accepted science about the safety of blood donated by MSM as
compared to other donor sources. There is compelling evidence
to suggest that this is the case. However, the resolution also
acknowledges social and political reasons that support changing
the FDA policy. Proponents favor implementing a policy that
takes into account the individual risk factors associated with
the sexual activity of a potential donor, regardless of his
sexual orientation, and believe such a policy would reflect the
spirit, if not the letter, of state anti-discrimination law,
while reflecting sound scientific principles. In addition, that
policy would presumably alleviate the fear of stigmatization,
long held by members of the gay community, associated with the
lifetime blood donation ban imposed on men who have sex with
other men.
Technical Amendments . The author proposes to make the following
technical amendments:
On page 2, strike lines 20-23, and insert "WHEREAS, the
nations of Argentina, Australia, Brazil, Hungary, Japan,
Sweden, and the United Kingdom, among others, have
adopted blood donor policies providing a 12-month
deferral period for men who have had sex with another
man. In addition, France,"
On page 3, line 15, after the second comma, insert
"2014,"
On page 3, line 24, strike "HIVMA, and ARC" and insert
"ARC, and the HIV Medicine Association (HIVMA)"
Add co-authors Senator Leno and Assemblymembers Ammiano,
Eggman, and Ting.
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Previous Legislation. AJR 13 (Ammiano) Res. Ch. 164, Statutes
of 2010, is similar to this resolution and urged federal
officials to adopt policies that repeal the current donor
suitability and deferral policies of the FDA regarding the
donation of blood by MSM.
REGISTERED SUPPORT / OPPOSITION :
Support
Equality California (sponsor)
Human Rights Campaign
Opposition
None on file
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334