July 14, 2015

Warren, Baldwin, Quigley, Lee Push FDA to Adopt Fully Risk, Science-Based Blood Donation Policy

Washington D.C. - Today, United States Senators Elizabeth Warren (D-MA) and Tammy Baldwin (D-WI), Representatives Mike Quigley (D-IL) and Barbara Lee (D-CA), and 79 of their congressional colleagues sent a letter to the Food and Drug Administration (FDA) in response to the agency's draft guidance document, which, if finalized, would change the blood donation policy for men who have sex with men (MSM) from a lifetime ban to a one-year deferral from the donor's last sexual contact with another man.

The bicameral letter requests 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toward implementing a risk-based blood donation policy for MSM," and requests that the agency consider amending the draft guidance document to clarify the agency's policy regarding donations from transgender individuals, to clearly delink the establishment of the Transfusion Transmissible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.

"While we appreciate the FDA's willingness to address this issue and release draft guidance to alter the current policy," the members wrote, "we continue to have deep concerns about many of the conclusions and statements made in the Draft, and about the lack of plan to move towards a fully risk-based system."

"Neither our current blood donation policy, nor the proposed one year deferral for MSM, allows the many healthy gay and bisexual men across America to donate blood... This serves to perpetuate the stereotype that all MSM pose a risk to the health of others. Both deferral policies are discriminatory and not based on science, and both approaches are unacceptable."

The policy that bans MSM from donating blood was put in place during the rise of the AIDS epidemic in the 1980s, and the AABB, the Red Cross, America's Blood Centers and the American Medical Association all agree that the ban is no longer scientifically justified in light of modern blood screening technology. Last year, after the completion of four studies conducted to inform the policy change, and a 16-2 vote by the Advisory Committee on Blood and Tissue Safety and Availability, the FDA announced that it intended to replace the lifetime deferral policy with a one-year deferral policy, contingent on the implementation of a blood safety surveillance system, while dismissing a risk-based policy.

This is the fourth Congressional letter led by Senator Warren, Senator Baldwin, Representative Quigley, and Representative Lee requesting that the discriminatory lifetime deferral from blood donation for MSM be replaced with a science-based policy.

The full text of the letter can be found here. The three previous letters led by this group can be found here: 8/2/2013, 9/8/2014, 12/15/2014.

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