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Quigley Directs FDA to Remove Blood Donor Biased Question

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WASHINGTON — Today, U.S. Representative Mike Quigley ( IL-05 ), Vice-Chair of the Congressional LGBT Equality Caucus, successfully included his amendment in the Fiscal Year 2017 Agriculture Appropriations bill instructing the Food and Drug Administration ( FDA ) to remove the discriminatory question on sexual orientation from its blood donor questionnaire and replace it with a question that is based on behavioral risk and sound science.

"We have made serious strides in full equality for the LGBTQ community, but outdated and discriminatory policies and questions like the one included in the blood donor history questionnaire must evolve to match advancements in science and technology," said Rep. Quigley. "As a leader in the fight to change the blood donation deferral policy for men who have sex with men, or MSM, I am encouraged by the progress we are making. But we can and must do more until would-be donors are screened solely on the basis actual risks and not sexual orientation. I thank Chairman Aderholt and Ranking Member Farr for including my amendment instructing the FDA to replace the question on sexual orientation in the donor history questionnaire."

Currently, the FDA's blood donor history questionnaire explicitly asks potential blood donors to disclose their sexual orientation as part of its donor risk assessment. However, this question is scientifically outdated and discriminatory given advances in blood screening technology and results in perfectly health would-be donors being turned away based solely on sexual orientation and not their level of risk. The questionnaire should not ask about sexual orientation and instead ask questions that assess risk factors that might expose a potential blood donor to blood-borne illness.

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 December 2015, the Food and Drug Administration ( FDA ) announced a policy change for the blood donor deferral policy for men who have sex with men ( MSM ) from lifetime ban to one-year deferral.

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.

Rep. Quigley has been a leader in the fight to change this outdated and discriminatory policy. Last summer, along with 82 of their congressional colleagues, Rep. Quigley 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. In 2014, in a letter to HHS Secretary Sylvia Burwell, Rep. Quigley, along with 78 of his 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, he urged HHS Secretary Burwell to reevaluate the current discriminatory, inconsistent blood, organ and tissue donation policies for MSM.

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