BILL ANALYSIS
AJR 13
Page 1
Date of Hearing: August 18, 2009
ASSEMBLY COMMITTEE ON JUDICIARY
Mike Feuer, Chair
AJR 13 (Ammiano) - As Amended: August 17, 2009
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?
FISCAL EFFECT : As currently in print this measure is keyed
non-fiscal.
SYNOPSIS
This measure, sponsored by Equality California, would urge 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 the 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 author, the sponsor, 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 collection agencies of recent advances in laboratory testing
and donor screening techniques was not enough to persuade FDA to
change its policy subsequent to the 2006 workshop.
Supporters of this resolution also believe it is not rational
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
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procedures should be revised to treat potential donors of
similar risk history alike, rather than on the basis of sexual
orientation. In addition to conforming FDA policy with good
scientific principles, supporters believe that removing the
broad prohibition on blood donation by MSM will prevent
unjustified stigma largely directed towards gay men and will
resolve any conflict between the policy and state
anti-discrimination law. Opponents of this resolution contend
current FDA policy is necessary to protect patients and the
blood supply from potentially infected blood, especially because
laboratory testing cannot detect HIV-infected blood with
complete accuracy.
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)States 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)States that current Food & Drug Administration (FDA) policy
prohibits any man who has had sex with another man since 1977
from donating blood for the rest of his life.
3)States 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. Further asserts that, to many
persons, this differentiation is unfair, creates stigma
without any justifiable public health imperative, and fosters
negative attitudes towards blood collection facilities and the
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eligibility criteria they use to screen donors.
5)Asserts 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.
6)States that blood banks routinely operate with a short supply,
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.
7)States the willingness of blood collection agencies 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)States 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)Asserts 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)Memorializes the President of the United States 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.
11)Memorializes the President and Secretary to direct the FDA to
develop science-based policies consistent with the history
described in the Resolution.
EXISTING LAW :
1)Pursuant to Food & Drug Administration blood donation policies
regarding screening and deferral of potential donors:
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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
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.)
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
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individual donors indicates any risk of transmitting disease via
blood transfusion. In support of the resolution, the author has
written:
In response to the AIDS crisis of the 1980's, the FDA
has banned any man who has had sex with another man
since 1977 from giving blood. . . [However] blood
banks in the United States routinely operate with a
short blood supply. Every day, cancer patients, people
with hemophilia, and others who need regular blood
transfusions rely on a readily available supply of
blood.
Three major blood collection agencies, the American
Red Cross, the American Association for Blood Banks,
and America's Blood Centers, have found that the
lifetime blood donation deferral [policy] for men who
have sex with men is medically and scientifically
unwarranted. Current blood donor screening techniques
eliminate the need for this policy.
It does not appear rational to broadly differentiate
sexual transmission of HIV via male-to-male sexual
activity from transmission via heterosexual activity.
In fact, high-risk heterosexual contact accounts for
27.6% of all HIV cases. Of these cases, 72.4% are
women. This differentiation is unfair and
discriminatory, stigmatizing willing donors for their
status rather than behavior. The policy sends a
harmful message to an entire group of people based on
outdated notions and practices, and unduly compromises
our nation's ability to supply blood and save lives.
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
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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.
The FDA has Indicated That the MSM Deferral Policy is Primarily
Based on Scientific Considerations . 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, 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
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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.
Therefore, 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)
Opponents of the resolution, including the Concerned Women of
America, a public policy women's organization, specifically cite
the FDA reference to "scientific models [showing] a small but
definite increased risk" to blood donation recipients (item 4
above) as evidence that current FDA policy is based on sound
science and reasonably intended to prevent a known risk of
transmitting disease.
Blood Donation Practices Involve 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 in the
first place. 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 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.
Despite Scientific Arguments Made by Blood Collection Agencies,
the FDA Declined to Change its Policy in 2006 . On March 8,
2006, 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
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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.
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
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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.
Supporters of this resolution have adopted the position of the
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 FDA to
"abandon current donor policies in favor of policies consistent
with sound science." It also calls upon the President and the
Secretary of the Department of Health and Human Services to
"direct FDA to develop science-based policies consistent with
the history described" in the resolution.
The FDA Policy Impacts Homosexual and Heterosexual Donors
Differently Without Regard to Individual Levels of Risk . 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. Supporters of the
resolution believe it is not rational for the FDA to broadly
differentiate sexual transmission via male-to-male sexual
activity from that via heterosexual activity. For example, as
the author notes:
A heterosexual man who has sex with a prostitute must
wait only one year before donating blood, whereas a
gay man in a monogamous relationship is banned from
donating blood for his entire life. There is no reason
that low-risk gay and bisexual men and high-risk
heterosexuals should be treated differently.
There is no absolute right under federal or California law to
donate blood, and the author does not contend that there should
be. However, the author does contend that FDA guidelines
conflict with state nondiscrimination policies and also
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"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 the Dr. Ronald Bayer of Columbia University, this
threat of stigmatization is something that gay advocates have
been concerned about since the FDA first implemented a 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
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 primarily
because it is inconsistent with sound science. 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.
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, would conform the
policy with 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.
ARGUMENTS IN OPPOSITION : Opponents of the resolution contend
that because lab testing methods of testing blood for HIV are
not infallible, current FDA policy is necessary to protect the
blood supply and public health from the risks posed by accepting
blood donation from MSM, a group that statistically have high
prevalence rates of HIV infection. For example, Capitol
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Resource Family Impact (CRFI), which identifies itself as
"California's leading pro-family public policy organization,"
writes in opposition:
Patients rely on blood donations to save their lives.
They expect that the blood they receive will be free
from disease. Therefore, the highest standards for
acquiring blood donations have long been established
by the Food and Drug Administration . . . (A)lthough
HIV testing has improved, it cannot detect 100% of
HIV-infected blood.
The FDA's policies are not discriminatory; they also
prevent donations from those who use intravenous drugs
or have been paid for sexual intercourse. These
measures protect innocent recipients who could survive
a life-threatening accident only to face life with an
incurable disease.
Author's Amendments. The author proposes to make the following
clarifying amendments to more clearly restate both California
anti-discrimination law and the FDA deferral policy for MSM
blood donors:
On page 1, lines 1-2, strike "The California State Legislature
encourages nondiscrimination" and insert "California law
prohibits discrimination".
On page 1, lines 3-4, strike "and gender identity and
expression" and insert "gender identity, and gender-related
appearance and behavior".
On page 1, strike lines 10-12 and insert "(FDA) donor deferral
policy, first established in 1983, effectively prohibits blood
donation by men who have had sex with another man even one time
since 1977; and".
REGISTERED SUPPORT / OPPOSITION :
Support
Equality California (sponsor)
National Center for Lesbian Rights
Santa Clara County Board of Supervisors
AIDS Legal Referral Panel
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Stonewall Democratic Club of Greater Sacramento
Southern California HIV Advocacy Coalition (SCHAC)
Gays & Lesbians United Against Discrimination
Opposition
Capitol Resource Family Impact
Concerned Women for America
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334