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I. Glenn Cohen, JD (Faculty Director); Jeremy Feigenbaum, JD; Eli Y. Adashi, MD, MS
JAMA
July 23, 2014

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Faculty Director I. Glenn Cohen has co-authored a new Viewpoint piece in the July 23/30, 2014 issue of JAMA, arguing for the end of the FDA's lifetime ban on blood donation by men who have sex with men. From the piece:

In 2013, the US Supreme Court took a historic step in United States v Windsor by striking down the Defense of Marriage Act on the grounds that it imposed a “disability on the class [of gay Americans] by refusing to acknowledge a status the State finds to be dignified and proper.”1 This milestone in gay rights stands in stark contrast to the ongoing lifetime ban imposed in 1983 on blood donation by men who have ever had sex with men (MSMs) even once.2 As it stands, the US Food and Drug Administration (FDA) continues to uphold this 30-year-old policy, unaltered, on the grounds that MSMs remain at increased risk of contracting transfusion-transmissible pathogens such as human immunodeficiency virus (HIV).2

This indefinite and indiscriminate policy has hardly gone unchallenged. The American Red Cross, America’s Blood Centers, and the American Association of Blood Banks have opposed the ban as “medically and scientifically unwarranted.” More recently, the American Medical Association and the American Osteopathic Association called for the replacement of the current policy with “rational, scientifically based deferral periods that are fairly and consistently applied.”3,4 In addition, a bipartisan and bicameral contingent of members of Congress wrote former Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius to “express concern with the progress of … evaluations of the current blood donation criteria for men who have sex with men.”5The above notwithstanding, the DHHS Advisory Committee on Blood Safety and Availability (ACBSA) reaffirmed the lifetime ban on blood donation by sexually active MSMs at its most recent meeting in December 2013.6 A change in policy is presently contingent on the establishment of “an ongoing, integrated, coordinated, and nationally representative US transfusion transmissible infections monitoring system” and on the conclusion of several federally funded studies.6 In this Viewpoint, we explore the shortcomings of the current policy of the FDA, examine its social, moral, and legal ramifications, and propose that an “assess and test” protocol, one focused on individual risk assessment, be instituted in its stead.

For more read Cohen's recent post on the subject at Bill of Health, or access the full article.

Access the Full Article

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bioethics   fda   health law policy   hivaids   human rights   i. glenn cohen   medical safety   public health