The U.S. Food and Drug Administration announced recommendations to change the longtime ban on blood donations by gay and bisexual men Dec. 23.
The new recommended policy, issued to the Secretary of the Department of Health and Human Services, would change the blood donor deferral period for men who have sex with men from indefinite deferral to one year since the last sexual contact, according to an FDA statement.
"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," said FDA Commissioner Margaret Hamburg in the statement.
But advocates for lifting the ban said that much more progress remains to be made on the issue.
Ramon Gardenhire, vice-president of policy for AIDS Foundation of Chicago (AFC), said, "We definitely applaud the FDA for changing course on this discriminatory ban. We would like more done, but this is still a great start."
Gardenhire added, however, "A one-year ban is still discriminatory and still perpetuates stigma against gay and bisexual men, who can make fine blood donors."
Virginia-based advocate Caleb Laieski, who in October filed a lawsuit that asked the ban be overturned, said, "Today progress was certainly made and more lives will be saved because of it. However, the one-year ban is still discriminatory and unnecessary. As HHS and the FDA clearly state, their testing is extremely accurate and the window period for HIV and STDs to show up is way under a year, so the year ban is still mind-blowing and non-science based."
Scott Schoettes, Lambda Legal Senior Attorney and Director of the HIV Project, said in a statement that "blood donation policy should be based on current scientific knowledge and experience, not unfounded fear, generalizations and stereotypes. Merely changing the parameters of this outdated policy does not alter its underlying discriminatory nature, eliminate its negative and stigmatizing effects, nor transform it into a policy based on current scientific and medical knowledge."
U.S. Rep. Mike Quigley, who has been active in a push to change the policy, called the change "disappointing" in a statement.
"A time-based deferral focusing solely on men who have sex with men is still discriminatory and fails to exclude donors based on actual risk factors," said Quigley. "However, as the leader of the bipartisan, bicameral effort to reverse the FDA's discriminatory policy, I remain encouraged by this ongoing conversation to change the outdated policy. I will continue to fight for a deferral policy based on behavioral risks, commensurate with the rest of the population and based on sound science, bringing equality for the LGBT community while still protecting the U.S. blood supply."
U.S. Sen. Tammy Baldwin, who also has been active in trying to get the ban lifted, added in a statement, "While this announcement represents needed progress, I remain concerned that it does not achieve our goal of putting in place a policy that is based on sound science and allows all healthy individuals to donate. … The Administration must continue to work towards implementing blood donation policies based on individual risk factors instead of singling out one group of people and turning away healthy, willing donors, even when we face serious blood shortages."
Gay and Lesbian Medical Association President Henry Ng and Executive Director Hector Vargas pledged to continue to have the ban fully lifted in a statement.
"GLMA supports nothing less than a paradigm shift away from any categorical restriction on MSM donating blood to a blood donation deferral policy based in individual behaviors," said Ng and Vargas. "… Knowledge about prevention, transmission and screening for HIV has changed significantly in the last 30 years and current testing technologies and window periods for detecting HIV and other blood-borne illnesses in the blood supply support a deferral period for at-risk sexual behavior of substantially less than one year. These developments only serve to reinforce GLMA's position that any categorical blood donation deferment for MSM for any length of time is arbitrary, stigmatizing and not scientifically supported."
Officials from the American Red Cross and the blood bank industry have opposed the ban, as has the American Medical Association. A September study released by the Los Angeles-based Williams Institute suggested that lifting the ban would increase the total annual blood supply by about 2%-4%. Basing their estimates on American Red Cross figures suggesting each donation has the potential to impact three lives, the researchers concluded that lifting the ban could potentially save the lives of 1.8 million people.
From AIDS Foundation of Chicago
The AIDS Foundation of Chicago (AFC) applauds the Food and Drug Administration (FDA) on their announcement today eliminating the outdated lifetime blood-donation ban for gay and bisexual men, enacting instead a rule that bans men who have had sex with men within the past year from donating blood. While the removal of the lifetime ban is a critical step forward, this one-year deferral period continues to unfairly discriminate against gay and bisexual men.
"It is very encouraging to see the FDA take this step and change what has been a longstanding, but inherently discriminatory policy," said John Peller, president/CEO of AFC.
The lifetime blood-donation ban originated during the early AIDS crisis when the disease was found mostly among communities of gay and bisexual men. Since then, important knowledge about HIV has emerged, making any ban both scientifically and medically unwarranted. While the policy change is an important step to destigmatize HIV as a "gay disease," further steps must be taken by the FDA to reduce the discriminatory effects of the policy.
To counteract stigma and discrimination, AFC urges the FDA to implement a risk-based deferral system for all prospective donors. A comprehensive screening system that assesses every donor's actual risk, regardless of sexual orientation, can improve the safety of the nation's blood supply without discriminating against and stigmatizing gay and bisexual men.
"The FDA still needs to do more to end unwarranted discrimination against gay and bisexual men while safeguarding the safety of the nation's blood supply," says Ramon Gardenhire, vice president of Policy at AFC. "A one-year ban is still unreasonable and discriminatory against gay and bisexual men, many of whom are safe blood donors."
AFC joins the growing national consensus on the need to improve the blood donation policies and discrimination against gay and bisexual men.
From Lambda Legal
( Washington, December 23, 2014 ) — The U.S. Food and Drug Administration ( FDA ) today announced it plans to move ahead with a recommendation to reduce the deferral period for blood donations from gay and bisexual men from the current lifetime ban to one year. This recommendation follows increasing calls from LGBT advocates and the medical establishment, including the American Red Cross, the American Association of Blood Banks, America's Blood Centers, and, most recently, the American Medical Association, to end the lifetime ban.
Scott Schoettes, Lambda Legal Senior Attorney and Director of the HIV Project, issued the following statement:
"This is a step in the right direction, but blood donation policy should be based on current scientific knowledge and experience, not unfounded fear, generalizations and stereotypes. Merely changing the parameters of this outdated policy does not alter its underlying discriminatory nature, eliminate its negative and stigmatizing effects, nor transform it into a policy based on current scientific and medical knowledge.
"Within 45 days of exposure, currently required blood donation testing detects all known serious blood-borne pathogens, including HIV. Therefore, a deferral of more than two months—for anyone—is not necessary and does not noticeably enhance the safety of the blood supply. Furthermore, donor deferrals should be based entirely on the conduct of the potential donor and not on sexual orientation, gender identity or the perceived health status or risk factors of the donor's sexual partners. The reason is straight-forward, and is a foundational principle of our prevention efforts: an adult person becomes HIV-positive—or acquires another blood-borne pathogen—only after engaging in activities that present a risk of transmission. To base deferrals primarily on prevalence within certain communities rather than behavior could serve to disqualify other segments of the population based on race, sex and where they reside—a very slippery slope toward more easily recognizable forms of illegal discrimination. If we are serious about a policy that is truly most protective of the blood supply, it will treat all potential donors the same and base any deferrals on the conduct of those potential donors within a scientifically justified 'window period' prior to donation.
"Lambda Legal also supports a fully-funded, more robust and comprehensive system for monitoring blood donations—particularly those donations that test positive for a blood-borne pathogen, like HIV or hepatitis C. Such a system—known as a 'hemovigilance' system—is the international standard and could inform further development of the donor questionnaire used to assess an individual's conduct-based risk, as well as to track any new, emerging infections before they have the chance to infiltrate the blood supply. But let's not pretend that further research is needed or that more information about the make-up of the current donor pool must be gathered before moving to an individualized risk-based assessment and much shorter deferral period. We already know the routes and relative risks of transmission for the blood-borne pathogens that recipients are legitimately concerned about, and we should move as swiftly as possible to a system that defers only individual donors who recently have engaged in activities placing them at risk—not to a system that still prevents groups of people from donating based simply on who they are.
From Gay Men's Health Crisis
New York, NY—Gay Men's Health Crisis ( GMHC ) believes the new policy announced by the FDA related to gay and bisexual men donating blood is offensive and harmful. Today, the FDA finally announced that gay and bisexual men may finally be allowed to donate blood - but only if they are celibate for one year, regardless of their risk for HIV. However, this new policy does not require heterosexual blood donors to be celibate for one year. Some may believe this is a step forward, but in reality, requiring celibacy for a year is a de facto lifetime ban.
Since the first days of epidemic, GMHC has witnessed first-hand how fear, stigma, and discrimination have fueled the spread of HIV. By implementing this policy, the FDA will continue to fan the flames of the outdated stereotype that HIV is only a "gay disease." The American Medical Association, the Red Cross, America's Blood Centers, and the Association of Blood Banks agree that the lifetime ban is not only discriminatory but is also medically and scientifically unwarranted.
This is why GMHC has been a leader in the fight to replace the FDA's outdated and unscientific blood ban with a system that screens all donors - gay or straight - based on whether they engage in high-risk practices that could lead to HIV infection. After all, HIV is transmitted by what you do, not who you are.
While the FDA is right to revisit the outdated lifetime ban, GMHC calls on the FDA and HHS Secretary Burwell to implement a risk-based blood donation policy, regardless of sexual orientation or gender identity, and to stop perpetuating the stigma and discrimination driving the HIV/AIDS epidemic.
From U.S. Senator Tammy Baldwin
Washington, D.C. — U.S. Senator Tammy Baldwin issued the following statement on the announcement by the U.S. Department of Health and Human Services ( HHS ) that it will change its blood donation policy for gay and bisexual men from a lifetime ban to one requiring a year of abstinence prior to donating blood and will take steps to implement a national blood surveillance system.
"I am encouraged that the Obama Administration has taken this step forward because I have long fought to revise this outdated policy that is medically and scientifically unwarranted. Our goal is to replace this discriminatory, lifetime ban on blood donations by healthy gay and bisexual men with a policy based on individual risk. While this announcement represents needed progress, I remain concerned that it does not achieve our goal of putting in place a policy that is based on sound science and allows all healthy individuals to donate.
"The Administration must continue to work towards implementing blood donation policies based on individual risk factors instead of singling out one group of people and turning away healthy, willing donors, even when we face serious blood shortages. I look forward to seeing the Administration's plans to continue this progress, and I stand ready to continue to work with them and my colleagues in Congress to achieve this goal."
Last week, Senator Baldwin led over 75 members of Congress in calling on HHS Secretary Sylvia Burwell to end the outdated and discriminatory ban, and replace it by instituting a risk-based policy. ( Legislators Call on HHS to End Discriminatory Blood Donation Policy, Implement Risk-Based Policies )
On June 18, 2013, the American Medical Association ( AMA ) passed a resolution opposing the current lifetime ban as discriminatory and not based on sound science. Instead, the AMA supports new donation deferral policies that are based on an individual's level of risk. The blood banking community, including the American Red Cross and America's Blood Centers, has also long-supported a change in policy.
From the American Civil Liberties Union
INDIANAPOLIS — The American Civil Liberties Union and the ACLU of Indiana filed a lawsuit today on behalf of three students at North Putnam High School who have been denied the right to form a Gay-Straight Alliance (GSA) club during non-instructional time at school, claiming the school's denial violates both federal law and the U.S. Constitution. The lawsuit is also brought on behalf of the GSA.
GSAs are student-run extracurricular clubs that bring together lesbian, gay, bisexual, transgender and allied students to support each other and promote respect and equality. LGBT students at the school have frequently been harassed and wanted to form the GSA to provide a place to educate the community and support vulnerable students.
The school, which allows other non-school-sponsored clubs and activities to meet, such as the Fellowship of Christian Athletes, Key Club and Best Buddies, has denied recognition of the GSA club for more than a year. The students followed all the school's required procedures outlined in its student handbook to establish the club, including securing a faculty member to supervise the group.
On Nov. 20, after a year of stalling, the North Putnam School Board voted to bar the club from forming, despite the fact that other clubs are not made to pass a school board vote. The school's denial of the GSA club violates students' First Amendment rights and the federal Equal Access Act. The students are seeking to have their application for the club approved and to allow it all rights similar to those of other extracurricular clubs.
"The law is clear in this matter," said Ken Falk, legal director at the ACLU of Indiana. "There is no excuse for the school district's intransigence, which is causing real harm to its students."
The ACLU of Indiana was successful in reversing a similar decision by a school in the Town of Munster in July, 2014.
"The actions of the school district in clear violation of federal law leave the most vulnerable students at North Putnam without critically needed support," said Chase Strangio, attorney in the ACLU Lesbian, Gay, Bisexual and Transgender Project.
The case, Gay-Straight Alliance at North Putnam High School, et al. v. North Putnam Community School Corporation, Case no. 2:14-cv-398JMS-WGH, was filed on Dec. 23, in the U.S. District Court for the Southern District of Indiana, Terre Haute Division.
From the Gay and Lesbian Medical Association
GLMA calls for optimal policy addressing individual behavior, remains concerned about stigmatizing impact on gay and bisexual men
The Food & Drug Administration (FDA) announced today it is planning to remove the decades-old FDA policy banning any man who has had sex with another man since 1977 from donating blood and replacing it with a one-year deferral period for MSM. GLMA President Henry Ng, MD, MPH, and Executive Director Hector Vargas, Esq., issued the following statement:
"The FDA's removal of the lifetime ban on blood donation for MSM is an important first step toward an optimal blood donation deferral policy addressing individual behaviors, including specific at-risk sexual behavior regardless of sexual orientation or gender, that would justify a deferral period based on the science. GLMA supports nothing less than a paradigm shift away from any categorical restriction on MSM donating blood to a blood donation deferral policy based in individual behaviors. While the removal of the lifetime ban is a step in the right direction, GLMA remains concerned about the one-year deferral period for MSM being proposed by the FDA today because it continues to perpetuate stigma among gay and bisexual men.
"Since 1983, when the FDA first addressed blood donation by MSM and effectively banned gay and bisexual men from donating blood, GLMA has called for a blood donation deferral policy that is rooted in up-to-date science, promotes the safety of blood products and ends the stigmatizing impact of the FDA policy on gay and bisexual men. Knowledge about prevention, transmission and screening for HIV has changed significantly in the last 30 years and current testing technologies and window periods for detecting HIV and other blood-borne illnesses in the blood supply support a deferral period for at-risk sexual behavior of substantially less than one year. These developments only serve to reinforce GLMA's position that any categorical blood donation deferment for MSM for any length of time is arbitrary, stigmatizing and not scientifically supported.
"GLMA calls on the FDA to commit to a reasonable timeline to develop a blood donation policy that addresses individual behaviors, including specific at-risk sexual behavior regardless of sexual orientation or gender. GLMA further calls on the FDA to establish a robust hemovigilance system that contributes to a safe blood supply. We pledge to continue our 30-year effort—with our partners and the FDA—to support these necessary and scientifically-sound changes."
The FDA plans to issue proposed guidance open to public comment on this policy change in early 2015. This fall, GLMA President-Elect Jesse Joad, MD, MS, represented GLMA before two advisory committees reviewing the blood-donation policy. Click here to read more about GLMA's efforts on this issue.
