DearColleague.us

Letter

From: The Honorable Diane E. Watson

Sent By: jillian.schlotter@mail.house.gov Date: 3/23/2009

URGE THE FDA TO BASE THEIR BLOOD DONATION DEFERRAL POLICIES ON SOUND SCIENCE AND MEDICAL NEED.

Current cosigners: Honda, Grijalva, and Nadler

Deadline extended: COB Tuesday, March 24, 2009

Dear Colleague,

Every two seconds somebody in the United States needs blood, and yet in any given year only 5% of the population donates. With blood scarcities a common occurrence in communities across the country I invite you to join me in sending a letter to the FDA urging their Blood Products Advisory Committee (BPAC) to follow up on its promise in 2006 to reevaluate their behavior-based blood donation deferral policies.

Under current FDA policy any man who has had sex with men (MSM) since 1977 is indefinitely prohibited from donating blood. This policy constitutes a lifetime ban for all MSM based on their sexual orientation rather than the risk level of their sexual behavior.

The MSM lifetime deferral policy originated in 1983 to protect the nation’s blood supply from the then new HIV epidemic, but this policy has yet to be fully reevaluated in a modern context. This policy fails to

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differentiate between high and low risk MSM activity, and instead relies on generalizations to justify a double-standard for MSM compared to heterosexual donors who engage in high-risk sexual activities.

Current blood donations undergo improved duplicate testing procedures using the nucleic acid amplification test (NAT) and serological methods which detect HIV-infection 10 to 21 days after exposure. Given this three week window period it is illogical and medically unnecessary to defer donors based on sexual behavior which occurred up to 32 years ago.

In March 2006 The American Red Cross, America’s Blood Centers, and the American Association of Blood Banks (AABB), the organizations responsible for collecting and distributing the nation’s blood supply, urged the BPAC to replace the MSM policy with a one-year deferral. This one-year deferral policy has been successfully implemented in Argentina, Australia, Hungary, and Japan with no indication of increased risk of HIV transmission. Spain! and Italy have both implemented policies based on the risk level of sexual behavior regardless of gender or sexual orientation since 2001 resulting in a decrease in the rate of HIV infections due to blood transfusions.

With the availability of a dependable blood supply entirely reliant on donations it is irresponsible to continue a medically unnecessary policy which restricts the number of eligible donors, and is often viewed as discriminatory.

Please join me in sending the attached letter to FDA Acting Commissioner Dr. Frank M. Torti to replace this outdated prohibition with policy based on sound science and medical need.

If you would like to sign on or have any questions, please contact Jillian Schlotter at jillian.schlotter@mail.house.gov, 5-7084. The deadline for signatures is COB Tuesday, March 24, 2009.

Sincerely,

/s Diane E. Watson

Member of Congress

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March __, 2009

The Honorable Dr. Frank M. Torti

Acting Commissioner of Food and Drugs

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Dear Acting Commissioner Torti,

Every two seconds somebody in the United States needs blood, and yet in any given year only 5% of the population donates. In light of this disconnect between an unstable supply and extremely high demand we are writing to you today to urge that the FDA’s Blood Products Advisory Committee (BPAC) follow up on its promise in 2006 to reevaluate their behavior-based blood donation deferral policies.

Under current FDA policy all men who have had sex with men (MSM) since 1977 are indefinitely prohibited from donating blood. This policy constitutes a lifetime ban for all MSM based on their sexual orientation rather than the risk-level of their sexual behavior. With blood scarcities a common occurrence in communities across the country it is counterintuitive to restrict an entire segment of the population from contributing to the blood supply based on assumptions rather than science or medical need.

The MSM lifetime deferral policy originated in 1983 to protect the nation’s blood supply from the then new HIV epidemic, but this policy has yet to be fully reevaluated in a modern context. This policy fails to differentiate between high and low risk MSM activity, and instead relies on generalizations to justify a double-standard for MSM compared to heterosexual donors who engage in high-risk sexual activities.

Current blood donations undergo improved duplicate testing procedures using the nucleic acid amplification test (NAT) and serological methods which detect HIV-infection 10 to 21 days after exposure. Given this three week window period it is illogical and medically unnecessary to defer donors based on sexual behavior which occurred up to 32 years ago.

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The American Red Cross, America’s Blood Centers, and the American Association of Blood Banks, the organizations responsible for collecting and distributing the nation’s blood supply, all supported replacing the lifetime deferral policy with a one-year deferral in testimony before the BPAC in March 2006. A one-year deferral policy for MSM would be consistent with the deferral period for other potentially high-risk behaviors, and would increase the accuracy of donor responses to screening questions by focusing on recent behaviors.

Due to the implications of improved testing procedures, and evidence that unprotected sex or sex with unknown partners results in a higher level of risk regardless of gender, other countries have begun to review and revise their MSM deferral policies. The one-year deferral period has been implemented in Argentina, Australia, Hungary, and Japan with no indication of an increased risk of HIV transmission. Since 2001 both Italy and Spain have replaced their MSM deferral practices with a policy based on the risk level of a donor’s s! exual behavior regardless of sexual orientation. Since implementing this change both Spain and Italy have experienced a decline in the rate of HIV-infection due to blood transfusions, with 24 reported cases in Spain in 1999 to just 4 reported cases in 2004.

At the completion of a two day conference entitled Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testingin March 2006, the BPAC decided to postpone a decision on revising the MSM deferral policy under the guise that they would revisit the issue for final consideration in the future. For three years this has failed to happen. The FDA’s reluctance to accept a change in the MSM deferral policy centered on a perceived lack of concrete data that would indicate that allowing MSM to donate would not increase the risk of HIV infection to the blood supply. This argument perpetuates inaction because it is impossible to generate such data without allowing MSM to begin donating blood, or as the BPAC admits without relying on models based heavily on unverifiable assumptions and speculations. This argument also ignores ! the examples of foreign countries where a change in MSM donation policy has had either a positive or neutral effect on the HIV infection rate due to blood transfusions.

This medically unwarranted policy is often viewed as discriminatory resulting in negative attitudes to blood donation, the boycott of blood drives on college campuses, and the possibility that potential donors may ignore the prohibition and provide blood collection facilities with false information further threatening the integrity and quantity of the blood supply. With the availability of a dependable blood supply entirely reliant on donations it is irresponsible to continue a medically unnecessary policy which damages the image and operations of blood drives.

As the Acting Commissioner of the FDA we are extremely grateful for the leadership you have provided ensuring the safety of our nation’s food, drugs, cosmetics, and biological products. We sincerely hope that you will urge the BPAC to revisit this issue as promised in 2006, and to replace an unwarranted prohibition with policy based on science and medical need.

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Thank you for your time and attention to this matter.

Sincerely,