BILL ANALYSIS Ó
AJR 16
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Date of Hearing: June 16, 2015
ASSEMBLY COMMITTEE ON JUDICIARY
Mark Stone, Chair
AJR 16
(Eduardo Garcia) - As Amended June 8, 2015
SUBJECT: BLOOD DONATIONS
KEY ISSUE: IN LIGHT OF CHANGES PROPOSED TO THE FOOD AND DRUG
ADMINISTRATION'S BLOOD DONATION DEFERRAL POLICY AFFECTING MEN
WHO HAVE HAD SEX WITH OTHER MEN, should THE LEGISLATURE URGE THE
FEDERAL GOVERNMENT TO HAVE THE fda ADOPT SCIENCE-BASED DONOR
SUITABILITY POLICIES THAT DO NOT UNNECESSARILY DISCRIMINATE
AGAINST POTENTIAL BLOOD DONORS ON THE BASIS OF THEIR SEXUAL
ORIENTATION?
SYNOPSIS
Current FDA policy, adopted in 1992, essentially prohibits blood
donation by any man who has had sex with another man (MSM) since
1977. In May of 2015, the FDA issued a draft guidance document
recommending the donor deferral period for MSM be changed from a
lifetime deferral to a period of one year since the last sexual
contact. Under the proposed FDA policy, a sexually active gay
man is barred from donating, even if he has only one sexual
partner, has protected sex, and has not been exposed to HIV. On
the other hand, the proposed policy would allow sexually active
heterosexual men and women under similar circumstances to donate
blood, even though some could have been exposed to HIV.
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Apparently, the only way a sexually active gay man can donate
blood under the newly proposed policy is to abstain from sex for
12 months prior to the date of donation, which supporters of
this measure contend is an unfair standard that is not applied
to heterosexual monogamous relationships, and not based on risk
behavior independent of sexual orientation.
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 current and
proposed Food & Drug Administration's donor deferral policies
regarding men who have sex with men, both of which proponents
believe unfairly discriminate on the basis of sexual
orientation. Supporters of this resolution also believe the FDA
should not 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 with
similar risk histories in the same manner, rather than on the
basis of sexual orientation. There is no known opposition to
this measure.
SUMMARY: Requests the President and the Department of Health
and Human Services (HHS) 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 measure:
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, since 1983, Food & Drug Administration (FDA)
policy has prohibited the donation of blood by any man who has
had sex with another man (MSM) at any time since 1977.
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3)Finds that in December 2014, based on recommendations from the
HHS Advisory Committee on Blood and Tissue Safety and
Availability, the FDA announced its intent to promulgate
regulations to allow an MSM to donate blood only if he has not
been sexually active for the past 12 months.
4)Further declares that despite these recent steps toward a
policy change, a double standard would still exist under the
policy as it is proposed to be revised because it would still
treat gay and bisexual men differently from heterosexual men.
5)Finds that Spain, Italy, Russia, Mexico, and Portugal have
adopted blood donor policies that measure risk against a set
of behaviors, sexual and otherwise, rather than the sex of a
person's sexual partner or partners.
6)Finds that the FDA does not allow gay and bisexual men in
committed relationships to donate blood because, while one
partner may be monogamous, that individual cannot guarantee
that the other partner is monogamous. The FDA does not apply
this same logic to heterosexual relationships, which in effect
discriminates against gay and bisexual men.
7)Finds that a 12-month deferral policy for gay and bisexual men
to donate blood is overly stringent given the scientific
evidence, advanced testing methods, and the safety and quality
control measures in place within the different FDA-qualified
blood donating centers. The technology can identify within 7
to 10 days with 99.9 percent accuracy whether or not a blood
sample is HIV-positive, and the chance of the blood test being
inaccurate within the 10-day window is about 1 in 2,000,000.
8)Finds that the General Social Survey conducted by NORC at the
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University of Chicago estimates that 8.5 percent of men in the
United States have had at least one male sexual partner since
18 years of age, 4.1 percent of men report at least one male
sex partner in the last 5 years, and 3.8 percent report a male
sex partner in the last 12 months.
9)Finds that an estimated 45.4 percent of men (54 million) in
the United States are eligible to donate blood, but only 8.7
percent of eligible men actually do. Finds that there are
15.7 million donations of blood per year made by 9.2 million
donors, yielding approximately 1.7 donations per donor.
10)Finds that, according to the Williams Institute of the
University of California at Los Angeles School of Law, based
on the population of eligible and likely donors among the MSM
community, lifting the federal lifetime deferral policy on
blood donation by an MSM would result in 4.2 million newly
eligible male donors, of which 360,600 would likely donate,
generating 615,300 additional pints of blood. Further finds
that, applying national estimates to the California
population, the Institute estimates that lifting the ban on
MSM blood donations would add an additional 510,000 eligible
men to the current blood donor pool, of which 43,917 would
likely donate, resulting in an additional 74,945 donated pints
in California.
11)Calls upon the President to encourage, and the Secretary of
the U.S. Department of Health and Human Services to adopt
policies to repeal the current and upcoming discriminatory
donor suitability policies of the FDA regarding blood
donations by men who have had sex with another man and,
instead, direct the FDA to develop science-based policies such
as criteria based on risky behavior in lieu of sexual
orientation.
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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
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,
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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 prohibiting 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 that it 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.
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, excludes large
numbers of such men from giving blood. However, to account for
an infected person giving 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 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
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the possibility of false negative laboratory testing, and to a
lesser degree, the inadvertent release of infected blood to be
used in a transfusion.
Origin of the FDA Policy of Lifetime Donor Deferral for MSM.
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 ever since.
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
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AIDS. The FDA has previously cited a variety of epidemiological
and scientific data to justify a lifetime deferral policy for
MSM, 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 that 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
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blood recipients."
(http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/
QuestionsaboutBlood/ucm108186.htm.)
For Many Years, the FDA Has Declined to Change its MSM Deferral
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.
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 after 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 risk to
recipients posed by false negative screening in the laboratory
is 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
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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."
Subsequently, the Legislature has twice passed resolutions
calling for the FDA to repeal the lifetime deferral policy for
MSM and adopt policies based on the most current science: AJR 13
(Ammiano) Res. Ch. 164, Stats. 2010, and AJR 50 (Bloom) Res. Ch.
170, Stats. 2014.
Recent Announcement of Proposed Change: 12-month deferral for
MSM. On December 23, 2014, the FDA announced that it would
recommend changing the donor deferral period for MSM from a
lifetime deferral to a period of one year after last sexual
contact, and would issue a draft guidance recommending this
proposed change in 2015, including an opportunity for public
comment. In the announcement, FDA Commissioner Margaret Hamburg
stated:
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Over the past several years, in collaboration with other
government agencies, the FDA has carefully examined and
considered the available scientific evidence relevant to its
blood donor deferral policy for men who have sex with men,
including the results of several recently completed
scientific studies and recent epidemiologic data. Following
this review, and taking into account the recommendations of
advisory committees to the U.S. Department of Health and
Human Services (HHS) and the FDA, the agency will take the
necessary steps to recommend a change to the blood donor
deferral period for men who have sex with men from
indefinite deferral to one year since the last sexual
contact.
This recommended change is consistent with the
recommendation of an independent expert advisory panel the
HHS Advisory Committee on Blood and Tissue Safety and
Availability, and will better align the deferral period with
that of other men and women at increased risk for HIV
infection. (Available at:
http://www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm427843.htm)
In May 2015, the FDA issued its draft guidance document, titled
"Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood
Products." The document reviews recent data relevant to the
FDA's decision on the deferral policy for MSM and contains
nonbinding recommendations to entities that collect blood
donations, including the recommendation of deferral for 12
months after the most recent contact of any man who has had sex
with another man during the past 12 months, or any female who
has had sex during the past 12 months with a men who has had sex
with another man.
Proposed 12 Month Deferral Policy for MSM Treats Homosexual and
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Heterosexual Donors Differently Without Regard to Individual
Levels of Risk. Under the proposed FDA policy, potential blood
donors are judged to be at risk for exposure because they have
had any sex whatsoever with another man in the previous 12
months, while men who have had heterosexual sexual contact in
the past 12 months are not necessarily deferred (as long as the
heterosexual partner did not have other risk factors). For
example, under the proposed FDA policy, a sexually active gay
man is barred from donating, even if he has had only one sexual
partner, has protected sex, and has not been exposed to HIV. On
the other hand, the proposed policy still allows sexually active
heterosexual men and women who may have been exposed to HIV to
donate, although after a deferral period of 12 months in some
cases. The only way a sexually active gay man can donate blood
under the proposed policy is apparently to abstain from sex for
12 months prior to donation, which critics of the proposed
policy contend is an unfair standard that is not applied to
heterosexual monogamous relationships, and not realistic in many
cases.
According to the FDA guidance document, however, the proposed
policy is scientifically justified. The guidance document
states: "Available epidemiologic data in the published
literature do not support the concept that [men who have sex
with men] who report mutual monogamy with a partner or who
report routine use of safe sex practices are at low risk for
HIV. Specifically, the rate of partner infidelity in ostensibly
monogamous heterosexual couples and same-sex male couples is
estimated to be about 25%, and condom use is associated with a 1
to 2% failure rate per episode of anal intercourse."
Recent media reports indicate that many LGBT advocates share the
author and sponsor's concerns about the proposed policy. For
example, David Stacy, director of government affairs at the
Human Rights Campaign (HRC), has stated that. "While the new
policy is a step in the right direction toward an ideal policy
that reflects the best scientific research, it still falls far
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short of a fully acceptable solution because it continues to
stigmatize gay and bisexual men. This policy prevents men from
donating life-saving blood based solely on their sexual
orientation rather than actual risk to the blood supply. It
simply cannot be justified in light of current scientific
research and updated blood screening technology." ("FDA Blood
Ban Donation Still Unacceptable," available at:
http://www.hrc.org/blog/entry/fda-blood-donation-ban-change-still
-unacceptable .)
The author contends that the proposed policy unnecessarily
limits the pool of potential blood donors in California who
could safely donate given today's screening technology and
procedures. Proponents state that, according to estimates by
the Williams Institute of the University of California at Los
Angeles School of Law, lifting the ban on MSM blood donations
would add an additional 510,000 eligible men to the current
blood donor pool in California alone, of which 43,917 would
likely donate, resulting in an additional 74,945 donated pints
of blood in this state.
In summary, the author and sponsor contend the proposed deferral
policy is still not justified in differentiating sexual
transmission via male-to-male sexual activity from that via
heterosexual activity. As the measure states: "Despite these
recent steps toward a policy change, a double standard would
still exist under the policy as it is proposed to be revised
because it would still treat gay and bisexual men differently
from heterosexual men." In addition, the measure finds and
declares that a 12-month deferral policy for gay and bisexual
men to donate blood is overly stringent given the scientific
evidence, advanced testing methods, and the safety and quality
control measures in place within the different FDA-qualified
blood donating centers.
Instead, proponents favor a policy that takes into account the
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individual risk factors associated with the sexual activity of a
potential donor, regardless of his sexual orientation, and
believe that such a policy would reflect the spirit, if not the
letter, of state anti-discrimination laws, 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 ever had sex with other
men.
REGISTERED SUPPORT / OPPOSITION:
Support
Equality California (sponsor)
Opposition
None on file
Analysis Prepared by:Anthony Lew / JUD. / (916) 319-2334
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