BILL ANALYSIS Ó AJR 16 Page 1 ASSEMBLY THIRD READING AJR 16 (Eduardo Garcia, et al.) As Amended June 8, 2015 Majority vote ------------------------------------------------------------------ |Committee |Votes|Ayes |Noes | | | | | | | | | | | | | | | | |----------------+-----+----------------------+--------------------| |Judiciary |8-2 |Mark Stone, Alejo, |Wagner, Gallagher | | | |Chau, Chiu, Cristina | | | | |Garcia, Holden, | | | | |Maienschein, | | | | |O'Donnell | | | | | | | | | | | | ------------------------------------------------------------------ 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. AJR 16 Page 2 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 AJR 16 Page 3 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 AJR 16 Page 4 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. AJR 16 Page 5 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 AJR 16 Page 6 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 AJR 16 Page 7 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 AJR 16 Page 8 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