Criticism High for FDA's New Blood Donation Policy

Yesterday, after more than 30 years, the Food and Drug Administration announced that it would recommend replacing their outdated lifetime blood donation ban on men who have sex with men, in favor of a one-year deferral period, requiring MSM to be celibate for a year prior to donation. While many consider this a step in the right direction, criticism still runs high for the policy, which many consider to be discriminatory toward gay and bisexual men.

"I am encouraged that the Obama Administration has taken this step forward because I have long fought to revise this outdated policy that is medically and scientifically unwarranted," said sponsor Sen. Tammy Baldwin. "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."

Last week, Senator Baldwin led over 75 members of Congress in calling on HHS Secretary Sylvia Burwell to end the outdated and discriminatory ban, and replace it by instituting a risk-based policy.

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 has also long-supported a change in policy.

"The HIV Medicine Association supports the important step forward the FDA has taken today by ending its lifetime ban on blood donation by men who have sex with men," said HIVMA Chair Adaora Adimora, MD, MPH. "[But] we are concerned that the new policy retains an unnecessary and unique exclusion of men who have sex with men from donating blood for one year. Requiring a one-year abstinence period for men who have sex with men, regardless of risk behavior, is not grounded in science regarding transmission risks or supported by current diagnostics for detecting HIV infection and other blood-borne pathogens."

The previous lifetime ban on MSM donating blood was put in place during the rise of the AIDS epidemic in the 1980s, but is no longer scientifically justified with current blood screening technology. In 2010, the HHS Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA) found the ban to be suboptimal and asked for re-evaluation of this policy. In response to a letter from legislators in 2013, HHS indicated that the Department would finish deliberations on a policy change to the blood ban by the end of 2014.

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.

From a legal perspective, the policy continues to be discriminatory, with Lambda Legal Senior Attorney and Director of the HIV Project Scott Schoettes saying that "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."

The change was supported by legislators on both sides of the aisle, with Rep. Mike Quigley recently leading a bipartisan, bicameral push, recently urging HHS Secretary Sylvia Burwell to reevaluate the current discriminatory, inconsistent blood, organ and tissue donation policies for MSM. Quigley called the policy change "disappointing."

"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. 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," said Quigley. "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."

AIDS United also called on the FDA to establish policies that carefully distinguish between high- and low-risk behavior based on a modern and medically based understanding of HIV transmission. Italy, Spain, Mexico, Chile, Uruguay, Poland, and Russia have successfully implemented similar blood-donation policies.

"The lifetime ban on gay men donating blood has not made sense for decades, but this first step is not enough" said Ronald Johnson, vice president of Policy and Advocacy at AIDS United. "We call on the FDA to move to an individualized, comprehensive and effective deferral system for all donors based on actual -- not perceived -- risk."

GMHC, a longtime member of the AIDS United Public Policy Committee, details how such a system could be implemented in their report, "A Drive for Change: Reforming U.S. Blood Donation Policies." They believe the new policy is "offensive and harmful," as it does not require heterosexual blood donors to be celibate for one year.

"Since the first days of epidemic, GMHC has witnessed first-hand how fear, stigma, and discrimination have fueled the spread of HIV," they wrote. "By implementing this policy, the FDA will continue to fan the flames of the outdated stereotype that HIV is only a 'gay disease.' 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."

AIDS United fully supports GMHC's findings and recommendations and urges the FDA to consider the report in future policymaking. They are among those calling for a hemovigilance blood screening system to track, report, investigate and analyze risks and adverse reactions that can occur as a result of blood transfusion. Such a system would increase the safety of the blood supply and provide an early warning system for potential threats.

"HIVMA strongly supports blood donor criteria that ensure a safe blood supply," said Adimora. "We recommend that blood donor screening procedures be revised to ask all potential donors to exclude themselves if within the previous six months they have tested positive for HIV, engaged in unprotected sex with a partner with HIV or unknown HIV status, or used a syringe not prescribed by a physician. The six-month deferral period is supported by a 2012 Australian Red Cross commissioned review. We urge that deferral criteria focus on risk behavior rather than sexual orientation and support recommendations for additional studies to develop blood donation deferral criteria that will protect the blood supply while reducing discriminatory exclusion of HIV-negative individuals."

Lambda Legal's Schoettes said that 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.

"Lambda Legal 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," said Schoettes. "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."

They say the time is long past for 'further research or information about he current donor pool,' pointing to the known routes for HIV transmission, and the success of similar systems throughout the world.

Baldwin, for one, vowed to continue to fight for a change in this policy, saying, "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."

And the National Gay Blood Drive said while they support the FDA's "huge first step in the right direction," it's only a first step.

"While this is a big success, there is still a long road ahead and a lot of work to do," said Ryan James Yezak, Founder and Executive Director of the National Gay Blood Drive. "We will continue to encourage the FDA to consider all the evidence until they arrive at a non-discriminatory policy and discrimination based on sexual orientation is eliminated from the blood deferral process altogether."