BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AJR 16
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|AUTHOR: |Eduardo Garcia |
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|VERSION: |June 25, 2015 |
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|HEARING DATE: |July 15, 2015 | | |
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|CONSULTANT: |Reyes Diaz |
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SUBJECT : Blood donations.
SUMMARY : Requests the President and the U.S. Department of Health and
Human Services to adopt science-based policies that repeal
current U.S. Food and Drug Administration policies that prohibit
men who have had sex with men from donating blood.
Existing law:
1)Pursuant to U.S. Food and Drug Administration (FDA) 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 (MSM) even one time
since 1977; and
d) Prohibits blood donation establishments from
allowing MSM, even one time since 1977, to donate
AJR 16 (Eduardo Garcia) Page 2 of ?
blood, even when such a donor does not wish to
self-defer.
2)Provides that all persons within the jurisdiction of this
state are free and equal. 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.
This measure:
1)Finds that, since 1983, the FDA has prohibited blood donation
by MSM at any time since 1977.
2)Finds that in December 2014, based on recommendations from the
U.S. Department of Health and Human Services (USHHS) Advisory
Committee on Blood and Tissue Safety and Availability, the FDA
announced its intent to promulgate regulations to allow MSM to
donate blood only if he has not been sexually active for the
past 12 months. Declares that a double standard still exits
under this proposed policy because it still treats gay and
bisexual men differently from heterosexual men.
3)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.
4)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.
5)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. Declares that the FDA
does not apply this same logic to heterosexual relationships,
which in effect discriminates against gay and bisexual men.
6)Finds that a 12-month deferral policy for gay and bisexual men
to donate blood is overly stringent given scientific evidence,
advanced testing methods, and safety and quality control
AJR 16 (Eduardo Garcia) Page 3 of ?
measures in place within the different FDA-qualified blood
donating centers. Declares that technology can identify within
seven to 10 days with 99.9% accuracy whether or not a blood
sample is HIV-positive, and the chance of the blood testing
being inaccurate within the 10-day window is about 1 in
2,000,000.
7)Finds that the General Social Survey conducted by NORC at the
University of Chicago estimates that 8.5% of men in the U.S.
have had at least one male sexual partner since 18 years of
age; 4.1% report at least one male sexual partner in the last
five years; and 3.8% report a male sex partner in the last 12
months.
8)Finds that an estimated 45.4% of men (or 54 million) in the
U.S. are eligible to donate blood, but only 8.7% actually do.
Declares that there are 15.7 million donations of blood per
year made by 9.2 million donors, yielding approximately 1.7
donations per donor.
9)Finds that the Williams Institute (Institute) of the
University of California at Los Angeles School of Law
estimates that, based on the population of eligible and likely
donors among the MSM community, lifting the federal lifetime
deferral policy on blood donations 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.
10)Finds that applying national estimates to the California
population, the Institute further 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 of the U.S. to encourage the USHHS
Secretary to adopt policies to repeal the current and upcoming
discriminatory donor suitability policies of the FDA regarding
blood donations by MSM and, instead, direct the FDA to develop
science-based policies, such as criteria based on risky
behavior in lieu of sexual orientation.
12)Requests the Chief Clerk of the Assembly to transmit copies
of this resolution to the President and the Vice President of
the U.S., to the USHHS Secretary, to the Speaker of the House
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of Representatives, to the Majority Leader of the Senate, and
to each Senator and Representative from California in the U.S.
Congress.
PRIOR
VOTES :
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|Assembly Floor: |62 - 6 |
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|Assembly Judiciary Committee: |8 - 2 |
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COMMENTS :
1)Author's statement. According to the author, this measure
would call upon the President of the U.S. to encourage the
USHHS Secretary to adopt policies to repeal the current and
upcoming discriminatory donor suitability policies of the FDA
regarding blood donations by MSM and, instead, direct the FDA
to develop science-based policies, such as criteria based on
risky behavior in lieu of sexual orientation.
2)Background. Blood banks now test donated blood by both
serologic (antibody) testing and the more recently developed
nucleic acid test method before the blood can be used in a
transfusion or contaminate other blood supplies. Both methods
allow detection of HIV-infected donors between 10 and 21 days
after exposure. When blood testing may not be able to detect
low levels of HIV is known as the critical window period.
According to the FDA, any man who has had sex with another man
even once since 1977 has been deferred as a blood donor
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 U.S. Although the
FDA policy uses the term "deferral," the policy in effect acts
to prohibit, in all cases, any man who has had sex with
another man even once 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 to all blood
donation establishments, titled "Revised Recommendations for
the Prevention of HIV Transmission by Blood and Blood
AJR 16 (Eduardo Garcia) Page 5 of ?
Products," 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. 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 blood recipients.
3)Recent Announcement of Proposed Change. 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, the
FDA states that 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 MSM, 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
USHHS and the FDA, the agency will take the necessary steps to
recommend a change to the blood donor deferral period for MSM
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 of the
HHS Advisory Committee on Blood and Tissue Safety and
Availability, and will align the deferral period with that of
other men and women at increased risk for HIV infection.
In May 2015, the FDA issued its draft guidance document,
titled "Revised Recommendations for Reducing the Risk of HIV
Transmission by Blood and Blood Products." The document
contains nonbinding recommendations to entities that collect
blood donations, including the recommendation of deferral for
12 months after the most recent contact of any MSM during the
past 12 months, or any female who has had sex during the past
12 months with an MSM.
4)Support. Equality California (EQCA), the sponsor, argues that
medical organizations like the American Red Cross, the
American Association for Blood Banks, America's Blood Centers,
AJR 16 (Eduardo Garcia) Page 6 of ?
and the American Medical Association have called for a
reevaluation and/or repeal of FDA's existing and proposed new
policy, citing its excessively broad nature and advances in
blood testing. EQCA also argues that the FDA policy creates
stigma without any justifiable public health imperative and
results in negative attitudes to blood donor eligibility
criteria and in blood collection facilities. EQCA further
states that the proposed new FDA blood donor guidelines
continue to discriminate against MSM.
SUPPORT AND OPPOSITION :
Support: Equality California (sponsor)
Oppose: None received.
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