BILL ANALYSIS Ó
AJR 16
Page 1
ASSEMBLY THIRD READING
AJR
16 (Eduardo Garcia, et al.)
As Amended June 8, 2015
Majority vote
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|Committee |Votes|Ayes |Noes |
| | | | |
| | | | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Judiciary |8-2 |Mark Stone, Alejo, |Wagner, Gallagher |
| | |Chau, Chiu, Cristina | |
| | |Garcia, Holden, | |
| | |Maienschein, | |
| | |O'Donnell | |
| | | | |
| | | | |
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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 (FDA) policies that
prohibit men who have had sex with men from donating blood.
Specifically, this resolution, among other things:
1)Finds that, since 1983, 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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2)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.
3)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.
4)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.
5)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
seven to 10 days with 99.9% accuracy whether or not a blood
sample is human immunodeficiency virus (HIV)-positive, and the
chance of the blood test being inaccurate within the 10-day
window is about one in 2 million.
6)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
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that, lifting the ban on MSM blood donations would likely 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.
7)Calls upon the President to encourage, and the Secretary of
the HHS 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.
FISCAL EFFECT: None
COMMENTS: This resolution, sponsored by Equality California,
respectfully requests the President and the HHS to adopt
policies that repeal current FDA 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.
Origin of the FDA Policy of Lifetime Donor Deferral for MSM.
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 acquired immune deficiency syndrome
(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
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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 previously 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 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." 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.
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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
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."
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), Resolution Chapter 164, Statutes of 2010, and AJR 50
(Bloom), Resolution Chapter 170, Statutes of 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
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comment. Subsequently, 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
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.
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
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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 lesbian, gay, bisexual,
and transgender (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 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
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transmission via male-to-male sexual activity from that via
heterosexual activity. 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 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.
Analysis Prepared by:
Anthony Lew / JUD. / (916) 319-2334 FN: 0000946