December 22, 2015

Warren Joins Quigley, Lee, and Baldwin in Responding to FDA Policy Change to Blood Donor Deferral Policy for MSM

Washington - U.S. Senator Elizabeth Warren joined Senator Tammy Baldwin (D-WI) and Representatives Mike Quigley (IL-05) and Barbara Lee (CA-13) in responding to the Food and Drug Administration's (FDA) change of the blood donor deferral policy for men who have sex with men (MSM) from a lifetime ban to a one-year deferral:

"This past year, we saw tremendous progress for the LGBT community with the legalization of same sex marriage nationwide. Unfortunately, today's official policy change by the FDA on blood donations from men who have sex with men (MSM) from a lifetime ban to one-year deferral does not keep up with that same progress," said. Rep. Quigley. "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 However, I remain encouraged by the ongoing conversation to change this outdated policy. As the leader of the bipartisan, bicameral effort to reverse the FDA's discriminatory 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."

"I am encouraged that the FDA swiftly finalized this guidance to move forward and revise the discriminatory lifetime ban on blood donations. However, this is just the first step toward ending an outdated policy that is medically and scientifically unwarranted," said Senator Baldwin. "This revision doesn't go far enough - and I expect the FDA to maintain its commitment to work with stakeholders to develop better blood donor policies based on science. I will continue to push the Administration to move forward to achieve our ultimate goal of blood donation policies that are based on individual risk factors, that don't unfairly single out one group of individuals, and that allow all healthy Americans to donate."

"The FDA's long-overdue decision to overturn the lifetime ban on blood donations from men who have sex with men (MSM) is an important step forward, but a one-year deferral policy for all MSM remains discriminatory," said Senator Warren. "The FDA says it will continue to reevaluate its policy, and the agency needs to commit to developing a risk-based framework for all blood donors that is based on current science. I will continue to press the agency to move in this direction in order to improve the safety and robustness of the blood supply."

"I applaud today's decision from the Food and Drug Administration to lift the discriminatory lifetime blood donation ban for members of the MSM community. However, the policy of one year deferral still maintains the long outdated policies concerning blood donations from the MSM community without scientific justification," said Rep. Lee. "Blood and blood products are critical to the treatment of many medical conditions and blood supplies are chronically low, especially around the holidays. Our blood donation policies should be based on science, not fear. I have called and will continue to call for blood donation policies that are based on the best possible science, data and technical capacity to ensure public health."

The previous lifetime ban on MSM donating blood was put in place during the rise of the AIDS epidemic in the 1980's, 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 will finish deliberations on a policy change to the blood ban by the end of 2014.

In 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.

Reps. Quigley and Lee and Senators Warren and Baldwin have been bicameral leaders in the fight to change this outdated and discriminatory policy. This summer, along with 79 of their congressional colleagues, the members sent a letter to the FDA requesting that the FDA implement the one year deferral policy "in a way that ensures that this is only a first step toward implementing a risk-based blood donation policy for MSM," and requests that the agency consider amending the draft guidance document to clarify the agency's policy regarding donations from transgender individuals, to clearly delink the establishment of the Transfusion Transmissible Infections Monitoring System from the change in the MSM blood donation policy, and to take action to reform and correct deficiencies in the Uniform Donor History Questionnaire. Last year in a letter to HHS Secretary Sylvia Burwell, the members, along with 75 of their colleagues, asked for additional information regarding the timeline for reversing the lifetime deferral policy, actions being taken to work towards a risk-based deferral policy, and plans for implementing the long-overdue blood safety surveillance system. Previously, they urged HHS Secretary Burwell to reevaluate the current discriminatory, inconsistent blood, organ and tissue donation policies for MSM.

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