BILL ANALYSIS
AJR 13
Page 1
ASSEMBLY THIRD READING
AJR 13 (Ammiano)
As Amended August 25, 2009
Majority vote
JUDICIARY 7-3
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|Ayes:|Feuer, Brownley, Evans, | | |
| |Jones, Krekorian, | | |
| |Huffman, Monning | | |
| | | | |
|-----+--------------------------+-----+--------------------------|
|Nays:|Tran, Knight, Miller | | |
| | | | |
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SUMMARY : Requests the President of the United States and the
Department of Health and Human Services (HHS) to adopt
science-based policies that repeal current Food and Drug
Administration (FDA) 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 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.
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
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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
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 of HHS to direct the
FDA to develop science-based policies consistent with the
history described in this resolution.
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FISCAL EFFECT : None
COMMENTS : This resolution, sponsored by Equality California,
respectfully requests the President and HHS to adopt policies
that repeal current FDA 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.
According to the FDA, men who have had sex with other men (MSM)
even one time since 1977 are indefinitely 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.
According to the FDA Web site, 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 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."
In 2006, 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 that FDA's lifetime deferral
policy for MSMs is medically and scientifically unwarranted.
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
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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.
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."
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
"inadvertently create unjustified stigma directed towards gay,
bisexual, transgender, and heterosexual males on the basis that
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they have had sex with another male since 1977."
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.
Opponents of the resolution, including two public policy
organizations, contend that current FDA policy is based on sound
science and that because lab testing methods of testing blood
for HIV are not infallible, the policy is still necessary to
protect the blood supply and public health from known risks of
transmitting disease posed by accepting blood donations from
MSM.
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334
FN: 0002398