Quigley Leads Coalition Urging FDA to Reexamine Discriminatory Blood donation Policy

WASHINGTON Today, Congressman Mike Quigley (D-IL) released a letter he sent to the Food and Drug Administration (FDA) urging them to reexamine outdated and discriminatory restrictions on blood donation by gay men. The FDA's current policy permanently bans men who have had sex with men from donating blood, while still permitting heterosexual individuals who have had sex with an HIV-positive partner to donate samples after a one-year deferral period. The issue has been the subject of an ongoing debate that has come to the forefront once again with President Obama's appointment of a new FDA Commissioner, Dr. Margaret Hamburg.

Quigley's letter to Dr. Hamburg was co-signed by ten other members of Congress (listed below) and argues that the ban is no longer necessary amidst technological advances and a growing demand and vital need for life-saving blood. The letter acknowledges the FDA's reliance on scientific data to determine its policies and, therefore, requests that the Administration conduct the necessary studies to ensure the safety of all those who undergo blood transfusions.

For the purposes of this release, the four-page letter has been excerpted as follows:

Today we write to discuss the Food and Drug Administration's (FDA) policy which currently defers any man who has had sex with a man even once since 1977 from ever donating blood.

The permanent deferral of men who have sex with men (MSM) was first implemented in the early 1980's, when the risk of AIDS from transfusion was first recognized. However, with technological advances in screening for HIV in donated blood, recent policy changes in other countries, and vocal opposition from the blood bank community in the face of a growing demand for blood, we are calling on the FDA to reexamine its MSM deferral policy.

We are not alone in our call for a reexamination of this outdated policy. The American Medical Association (AMA) supports changing the current lifetime deferral policy to a five-year deferral policy. Additionally, in March 2006, the AABB, America's Blood Centers (ABC) and American Red Cross (ARC) [called for] the deferral period for male to male sex be changed to 12 months, in order to make it consistent with the deferral period for other potentially high risk sexual exposures. The current policy creates a double standard where donors judged to be high risk due to heterosexual behavior are deferred for one year, while men who have had sex with another man even once since 1977 are permanently deferred.

The current FDA guidance which determines donor eligibility for the donation of human tissues is also inconsistent with its MSM blood donation deferral policy - men who have had sex with another man in the preceding 5 years, rather than since 1977, are considered ineligible to donate tissues. The FDA's guidance for tissue donation also defers persons who have had sex in the last 12 months with any person with HIV from donating tissues. An individual who has sex with an HIV positive individual is deferred for 12 months, while men who have sex with men even once since 1977 are deferred forever. These policies seem inconsistent and worthy of further examination.

In their letter to the FDA, the blood banking community also pointed to advancements in testing as providing a sufficient safeguard against infection. Current testing methods allow detection of HIV-infected donors between 10 and 21 days after exposure.

Another area which warrants examination is the donor eligibility questionnaire, which currently permanently defers potential donors for life based on one question regarding their sexual activity. Although having had a low number of partners is known to decrease the risk of HIV infection, the FDA argues that so far, there are no scientific studies that indicate questioning in the donor room (e.g., safe sex or monogamy) can accurately identify high risk donors. Yet the same questioning is used to pre-screen risks of heterosexuals.

Other nations have reexamined and altered their blood donation deferral policies, and we should look to them as examples. Sweden, which currently holds the presidency of the European Union, recently announced that on March 1, 2010, its deferral period for men who have sex with men will be changed to 12 months. Spain and Italy have adopted blood donation policies based on unsafe sexual activity, and Argentina, Australia, Japan and Hungary all call for deferral of men who have had sex with men for one year after sexual activity.

It is our understanding that the last time the deferral criteria was thoroughly examined by the FDA was in 2006. We feel that this sensitive issue warrants further examination and the risk models developed by FDA should be revised using assumptions that reflect the practices of 2009.

For many individuals this permanent ban is seen as unfair, discriminatory and serving to simply perpetuate the negative stereotype that all men who have sex with men are HIV positive.

According to the FDA's website, the agency remains willing to consider new approaches to donor screening and testing, provided those approaches assure that blood recipients are not placed at an increased risk of HIV or other transfusion transmitted diseases. We are calling on the FDA now to uphold this claim and reexamine its antiquated, discriminatory deferral policy that currently prevents healthy, disease-free men who have had sex with other men from donating blood.

We look forward to working with you on this vital, timely issue. We understand and respect the challenges facing the FDA as it tackles this complex issue, but we must stress that without further examination of this issue no change can be achieved.

Dr. Hamburg, who previously served as New York's health commissioner, has been historically proactive on HIV/AIDS issues. She has supported needle exchange programs and publically opposed efforts to require AIDS educators to teach abstinence to students.

Quigley's letter was co-signed by several members of Congress, including Representatives Jared Polis, Jerrold Nadler, Diane E. Watson, Barbara Lee, Debbie Wasserman Schultz, Sam Farr, Tammy Baldwin, Michael M. Honda, and Raul M. Grijalva.

A full copy of the letter is available upon request.