BILL ANALYSIS �
AJR 50
Page 1
ASSEMBLY THIRD READING
AJR 50 (Bloom)
As Amended August 20, 2014
Majority vote
JUDICIARY 8-2
-----------------------------------------------------------------
|Ayes:|Wieckowski, Alejo, Chau, | | |
| |Dickinson, Garcia, | | |
| |Maienschein, Muratsuchi, | | |
| |Stone | | |
| | | | |
|-----+--------------------------+-----+--------------------------|
|Nays:|Wagner, Gorell | | |
| | | | |
-----------------------------------------------------------------
SUMMARY : Requests the President and the Department of Health
and Human Services to adopt science-based policies that repeal
current Food and Drug Administration (FDA) policies that
prohibit men who have had sex with men (MSM) 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 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 Intravenous 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
AJR 50
Page 2
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)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.
6)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.
7)Calls upon the President to encourage, and the Secretary of
the United States 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.
FISCAL EFFECT : None
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 MSM 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 author, the FDA policy is "an outdated and discriminatory
policy that should be replaced scientific evidence-based
practices for collecting and testing donated blood."
AJR 50
Page 3
According to the FDA, 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.
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 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; and 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. 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
AJR 50
Page 4
recipients."
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. At
that workshop, three major blood collection agencies, the ARC,
the AABB, and 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. 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
AJR 50
Page 5
revising the FDA deferral policy with respect to MSM.
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
Web site: "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. 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." Furthermore, the author contends that
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 comments
made by Dr. Ronald Bayer of Columbia University at the FDA
workshop in 2006, 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.
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. 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
AJR 50
Page 6
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.
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334
FN: 0005021