City urges FDA to replace ban with evidence-based blood donation approach
Lifting ban would lead to an additional potential 360,600 blood donors and 615,300 pints of blood each year, saving an estimated 1.8 million lives
November 30, 2016 – The Health Department today announced it has called on the Food and Drug Administration (FDA) to change its blood donor deferral policy for men who have sex with men (MSM). This would allow an estimated additional 360,600 men to donate 615,300 additional pints of blood each year, increasing the total annual blood supply in the United States by 2 to 4 percent and helping to save the lives of more than 1.8 million people. New York City is the largest municipality to call for a change to the ban, joining a coalition of advocates including, GMHC, Lambda Legal, and Treatment Action Group (TAG).
The comment, submitted to the FDA and co-authored by Health Commissioner Dr. Mary T. Bassett, Commission on Human Rights Commissioner Carmelyn Malalis, and Department of Citywide Administrative Services (DCAS) Commissioner Lisette Camilo, calls on the FDA to lift its current policy prohibiting men who have had sex with men in the last 12 months from donating blood, and replace it with an evidence-based, three-step screening process that does not exclude potential donors on the basis of sexual orientation or gender of their sex partners. This recommendation is based on the agency’s clinical expertise in sexually transmitted infection management and extensive community consultation and engagement.
“Replacing the FDA’s current ban with a screening process based on science, not stigma, will maintain the safety of the blood supply, increase donations and save lives,” said Health Commissioner Dr. Mary T. Bassett. “The new screening process will allow thousands, if not hundreds of thousands, of gay and bisexual men to give the life-saving gift of blood.”
“Banning men who have sex with men from donating blood is an outdated and discriminatory policy,” said Commissioner and Chair of the NYC Commission on Human Rights, Carmelyn P. Malalis. “Replacing the FDA’s current blood donation policy with a new evidence-based screening process is not only long-overdue, but will ensure the safety of blood donations, encourage more people to donate, and contribute to the saving of more lives.”
“As the Chair of the New York City Employee Blood Program, one of the largest donor groups in the metropolitan region, I am dedicatedto raising awareness of the critical importance of donating blood,” said DCAS Commissioner Lisette Camilo. “By changing the blood donor deferral policy we will enable more City employees to participate in the life-saving act of donating blood.”
“Stigma-based exclusions are unnecessary with the advances in HIV screening. Technology, not bias, has and will keep blood safe,” said Dr. Demetre Daskalakis, Assistant Commissioner for the Health Department’s Bureau of HIV/AIDS Prevention and Control. “As a gay man, I look forward to the day that I am allowed to give blood and not be excluded based on my personal truth.”
“I strongly support the New York City Health Department in its efforts to lift the ban on blood donations by gay men,” said U.S. Senator Kirsten Gillibrand. “In too many emergencies with an urgent need for donated blood, it is unnecessarily difficult – or even impossible – for the medical community to meet demand, because an entire segment of the population is arbitrarily blocked from donating their blood. There is no medical or scientific evidence that should prevent certain men from donating blood simply because they are gay, and I have repeatedly urged the FDA to end this backward policy.”
“It is time to put an end to the FDA’s discriminatory blood donation ban and to move to a policy based on science,” said Congressman Eliot Engel, a senior member of the House Energy and Commerce Committee’s Health Subcommittee. “This change would allow for a critical boost to the blood supply, as well as remove a bias that gay men have needlessly faced for too long. I applaud the New York City Health Department for championing this much-needed change."
“The current 12-month deferral policy imposed by the FDA perpetuates a stigma against those who have MSM relationships that must be eliminated. The blood-donation questionnaire must not judge potential donors on their sexual orientation, but rather risk-based behaviors. This change is long overdue, and would help to save the lives of more than a million people across our nation. I am proud that New York is once again on the right side of history, leading the way for more equitable treatment of all Americans,” said Congresswoman Carolyn Maloney.
“Our knowledge of HIV/AIDS and how it is transmitted, treated and detected has changed dramatically since this discriminatory policy was first enacted in 1985,” said Congressman Jerrold Nadler (D-NY). “Our laws must be updated to reflect the current scientific understanding, instead of the stigmas and stereotypes of the past. I thank Mayor Bill de Blasio, Health Commissioner Dr. Mary T. Bassett, Commission on Human Rights Commissioner Carmelyn Malalis, and Department of Citywide Administrative Services Commissioner Lisette Camilo for putting forth this well-developed proposal on how we can bring discrimination in our blood donation system to an end.”
"As the Ranking Member of the Senate’s Health Committee and a staunch ally of our City’s LGBTQ community, I applaud our City's Health Department for calling on the FDA to replace the current MSM ban with an evidence-based, blood donation process," said State Senator Gustavo Rivera. "In doing so, our City is making a strong statement that all New Yorkers should be able to donate lifesaving blood, regardless of their sexual orientation."
“I join the NY Health Department in their call to the FDA to lift the ban on blood donations from gay men who have had recently had sex. Earlier this year, I joined 115 other Members of Congress in asking for the FDA to overturn this outdated and discriminatory blood donation policy. We must create a policy that is based on facts, and allow thousands of healthy gay men to once again be able to donate blood, increase our blood supply, and save lives,” said Congressman Jose Serrano.
“Blood donations should be screened for HIV and other blood-borne diseases regardless of the donor’s sexual orientation or the gender of donors’ sexual partners,” said Assembly Member Richard N. Gottfried of Manhattan, Chair of the Assembly Committee on Health. “By calling for an evidence-based, three-step screening process and an end to the senseless blanket ban on blood donations by men who have sex with men, the de Blasio administration and the New York City Health Department are siding with science and good public health policy.”
“I applaud New York City and its Health Department for calling on the FDA to abandon the blood donor deferral policy for gay men. This ban has been steeped in misguided emotion, and not scientific fact. We have the scientific know-how to utilize new screening processes to protect the public without discriminating against those who could help save lives,” said Assemblymember Deborah J. Glick.
“I stand with the Health Department in calling on the FDA to end this harmful and discriminatory ban,” said Council Member Corey Johnson, Chair of the Committee on Health. “When we shut out this entire population from donating, lives are put in danger and we institutionalize a bias against gay men. A scientific method for determining eligibility is achievable and it would save countless lives. I thank Health Commissioner Dr. Mary T. Bassett, Commission on Human Rights Commissioner Carmelyn Malalis, and their incredible staffs for addressing this critical issue at the crossroads of justice and public health.”
“I've always believed that those who are able to donate blood, should,” said City Council Majority Leader Jimmy Van Bramer. “It's an act of giving that saves lives. But because I am a gay man, I've been denied the ability to donate blood and help others. That's wrong. The science doesn't support such a ban on people like me donating blood and I am ready to donate as soon as this outdated policy is changed.”
"I stand with the Department of Health and Mental Hygiene to call on the Food and Drug Administration to end the restriction on blood donations from men who have sex with men. This policy is discriminatory and it should be lifted so that those individuals who want to donate blood can do so. An increased blood supply will translate into saving the lives of people who need blood transfusions. This policy is reinforces the old stereotype that HIV/AIDS is a gay man's disease. The FDA needs to rely on screenings, not stigma,” said NYC Councilwoman Rosie Mendez, Chair of the NYC Council LGBT Caucus.
"The FDA's current blood donor screening policy is unscientific and reinforces the stigma LGBTQ people have had to face for generations," said NYC Council Member Daniel Dromm. "As an openly gay elected official, I join the NYC Department of Health and Mental Hygiene in calling upon the FDA to immediately replace this harmful policy with one that is evidence-based. New York City is in almost perpetual need of blood donations. We cannot afford to exclude potential donors on the basis of sexual orientation or the gender of their sex partner."
"The FDA needs to end the blanket blood donation ban for men who have sex with men. It's an outdated policy based on stigma not science," said Council Member James Vacca. "As it stands today, a gay man who otherwise meets all the criteria to donate blood is denied if he has had sex in the past year. The ban should be replaced with a screening process based on science that would not prevent potentially lifesaving donations from gay men."
“For far too long the FDA has allowed a policy to stand that unfairly discriminates against and stigmatizes countless gay and bisexual men who just want to unselfishly and compassionately give blood. I’m very proud to see the Health Department calling for an end to this regressive and harmful policy,” said Council Member Brad Lander. “Who someone loves shouldn’t impact their ability to give blood. We should focus instead on science and evidence-based screening practices that don’t pre-exclude donors on the basis of their sexual practices. I hope the FDA will heed NYC’s call to update this outdated and discriminatory policy.”
“The City of New York has been a consistent champion for LGBT civil rights and it is especially critical that now, during these tumultuous and divided times, the city has joined the charge for a fair and scientific national blood donation policy. The current one-year deferral policy for men who have sex with men ignores the modern science of HIV-testing and perpetuates the discrimination we have been fighting for over 35 years. Our nation must move forward, and GMHC calls on more cities, states, elected officials, organizations, and advocacy groups to join in pushing for a policy that is based on science and not stigma,” said GMHC CEO Kelsey Louie.
In its comment to the FDA, the Health Department proposed the following three-step process for all potential blood donors:
- Blood donation centers should conduct a behavioral risk screening for every potential donor, regardless of assigned sex at birth, gender identity, presumed or actual sexual orientation, and sexual history. This screening should ask potential donors about behaviors during the past six months, including:
- HIV testing and status: Potential donors who report having tested positive for HIV should be excluded from blood donation;
- Syringe use: Potential donors who report having used a syringe not prescribed by a physician should be excluded from blood donation; and
- Sexual risk-taking behavior: Potential donors, regardless of presumed or actual sexual orientation, who report having had condomless sex, regardless of sexual partners’ assigned sex at birth or current gender identity, should proceed to the step below.
- Potential donors who report having had condomless sex during the past six months should be offered on-site HIV testing. For this step, donation centers should use sensitive point-of-care rapid diagnostic tests that enable detection of HIV early in the course of infection. A deferral period based on the testing technology, on the order of weeks, may further supplement this strategy. Test results should direct potential donors as follows:
- Negative: Potential donors who test negative for HIV should proceed to donation;
- Positive: Potential donors who test positive for HIV should receive post-counseling services as required by local law and be referred to care and treatment services. They should be excluded from blood donation; and
- Invalid: Potential donors with invalid test results should be tested again using a second device. If the second device produces a similar result, potential donors should be excluded from donation and referred to an alternative site for further testing.
- Blood donation centers should continue to perform nucleic acid-based testing of donated blood, per the FDA’s current recommendation.
The Health Department emphasizes that its recommended screening process is an opportunity to increase HIV testing rates and link more people to care while further improving the safety of the blood supply using science rather than stigma-based exclusions.
Christopher Miller/Julien Martinez, (347) 396-4177