This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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.

This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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.

This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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.

This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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 sexual behavior in lieu of sexual orientation.

This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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 sexual behavior in lieu of sexual orientation.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), has prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, 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. 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; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, 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 persons sexual partner or partners; and

WHEREAS, 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; and

WHEREAS, 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; and

WHEREAS, The General Social Survey conducted by NORC at the 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; and

WHEREAS, 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. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams 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 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. 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; now, therefore, be it

Resolved by the Assembly and the Senate of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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; and be it further

Resolved, That the Chief Clerk of the Assembly transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), has prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, 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. 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; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, 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 persons sexual partner or partners; and

WHEREAS, 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; and

WHEREAS, 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; and

WHEREAS, The General Social Survey conducted by NORC at the 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; and

WHEREAS, 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. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams 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 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. 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; now, therefore, be it

Resolved by the Assembly and the Senate of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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; and be it further

Resolved, That the Chief Clerk of the Assembly transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), has prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, 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. 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; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, 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 persons sexual partner or partners; and

WHEREAS, 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; and

WHEREAS, 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; and

WHEREAS, The General Social Survey conducted by NORC at the 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; and

WHEREAS, 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. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams 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 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. 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; now, therefore, be it

Resolved by the Assembly and the Senate of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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; and be it further

Resolved, That the Chief Clerk of the Assembly transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), has prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, 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. The HHS should be commended for this initial step towards equality, but a double standard still exists by treating gay and bisexual men differently from heterosexual men; 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; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, France, 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 persons sexual partner or partners; and

WHEREAS, 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; and

WHEREAS, 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; and

WHEREAS, The General Social Survey conducted by NORC at the 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; and

WHEREAS, 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. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams 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 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. 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; now, therefore, be it

Resolved by the Assembly and the Senate of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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 sexual behavior in lieu of sexual orientation; and be it further

Resolved, That the Chief Clerk of the Assembly transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), has prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, 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. The HHS should be commended for this initial step towards equality, but a double standard still exists by treating gay and bisexual men differently from heterosexual men; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, France, 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 persons sexual partner or partners; and

WHEREAS, 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; and

WHEREAS, 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; and

WHEREAS, The General Social Survey conducted by NORC at the 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; and

WHEREAS, 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. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams 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 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. 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; now, therefore, be it

Resolved by the Assembly and the Senate of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the United States Food and Drug Administration (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 sexual behavior in lieu of sexual orientation; and be it further

Resolved, That the Chief Clerk of the Assembly transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

 THIRD READING  

Bill No: AJR 16

Author: Eduardo Garcia (D), et al.

Version: 6/25/15 in Assembly

Vote: 21

SENATE HEALTH COMMITTEE: 7-2, 7/15/15

AYES: Hernandez, Hall, Mitchell, Monning, Pan, Roth, Wolk

NOES: Nguyen, Nielsen

ASSEMBLY FLOOR: 62-6, 6/25/15 - See last page for vote

SUBJECT: Blood donations

SOURCE: Equality California

DIGEST: This resolution 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.

ANALYSIS:

Existing law:

1. Pursuant to U.S. Food and Drug Administration (FDA) blood donation policies regarding screening and deferral of potential donors:

1. Requires that potential donors are informed about the risk of transmitting infectious diseases through blood donation;

2. 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;

3. 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

4. Prohibits blood donation establishments from allowing MSM, even one time since 1977, to donate 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 resolution:

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 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 of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the U.S. Congress.

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 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.

FISCAL EFFECT: Appropriation: No Fiscal Com.: No Local: No

SUPPORT: (Verified 8/7/15)

Equality California

City of West Hollywood

OPPOSITION: (Verified 8/7/15)

None received

ARGUMENTS IN 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, 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.

ASSEMBLY FLOOR: 62-6, 6/25/15

AYES: Achadjian, Alejo, Baker, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Daly, Dodd, Eggman, Frazier, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Hadley, Roger Hernández, Holden, Irwin, Jones-Sawyer, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mayes, McCarty, Medina, Mullin, Nazarian, O'Donnell, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Mark Stone, Thurmond, Ting, Weber, Wilk, Williams, Wood, Atkins

NOES: Brough, Beth Gaines, Grove, Harper, Wagner, Waldron

NO VOTE RECORDED: Travis Allen, Bigelow, Dahle, Gallagher, Jones, Kim, Mathis, Melendez, Obernolte, Olsen, Patterson, Steinorth

Prepared by: Reyes Diaz / HEALTH /

8/13/15 13:24:38

**** END ****

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AJR 16

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:

   1. Requires that potential donors are informed about the risk of transmitting infectious diseases through blood donation;

   2. 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;

   3. 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

   4. Prohibits blood donation establishments from allowing MSM, even one time since 1977, to donate 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 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 of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the U.S. Congress.

PRIOR VOTES:

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 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, 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.

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AJR 16

Author:(Eduardo Garcia, et al.)

As Amended Ver:June 8, 2015

Majority vote

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.

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 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 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.

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 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 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 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

Date of Hearing: June 16, 2015

ASSEMBLY COMMITTEE ON JUDICIARY

Mark Stone, Chair

ABPCA Bill Id:AJR 16

Author:(Eduardo Garcia) – As Amended Ver: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. 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.

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 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.

EXISTING LAW:

1. Pursuant to Food & Drug Administration blood donation policies regarding screening and deferral of potential donors:

   1. Requires that potential donors are informed about the risk of transmitting infectious diseases through blood donation.

   2. 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.

   3. 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.

   4. 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, 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 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 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 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 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:

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 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 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 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