Blood Safety Update

For the past few weeks, media attention, US Senate interest and federal agency meetings scheduled on the topic of blood safety and donor deferral criteria have been circulating. Specifically, Senator John Kerry (D-MA) sent a letter to the FDA Commissioner, with 17 other Senators’ co-signatures requesting a review of the deferral criteria for prospective blood donors and the ban on men who have had sex with other men (MSM).
The HFA is committed to providing information to the community so that you are empowered to develop your own opinions based on the facts available.  We also wish you to know that HFA and other national consumer organizations are weighing in on these relevant issues and advocating for the best interests of individuals with bleeding disorders.  In particular we recognize the Committee of Ten Thousand (COTT) and the World Hemophilia Federation (WHF) for their continued leadership in the area of blood safety. 
In that spirit, we are providing the following resources:  
The FDA current policy re: Blood Donations from Men Who Have Sex with Other Men
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/ucm108186.htm
March 4, 2010 Letter to FDA from US Senators requesting a review of the lifetime deferral requirement for men who have sex with men wishing to donate blood and a reexamination of the deferral criteria for all blood donors
https://hemophiliafed.org/uploads/2010/04/Senators-LETTER-TO-FDA-ON-MSM-2-3-4-2010-3.pdf
Gay Men’s Health Crisis Report: A Drive for Change – Reforming US Blood Donation Policies
http://www.gmhc.org/files/editor/file/a_blood_ban_report2010.pdf
Centers for Disease Control and Prevention (CDC) Dear Colleague-MSM-March 10, 2010
https://hemophiliafed.org/uploads/2010/04/CDC-Dear-Colleague-STD-MSM.pdf
Centers for Disease Control and Prevention: HIV AIDS and Young Men Who Have Sex With Men
http://www.cdc.gov/healthyyouth/sexualbehaviors/pdf/hiv_factsheet_ymsm.pdf
Hemophilia Federation Letter in response to March 4, 2010 Letter from US Senators
https://hemophiliafed.org/uploads/2010/04/HFA-Response-MSM-BloodSafety-7.pdf
World Hemophilia Federation: WFH Statement on Blood Donor Deferrals (2007)
http://www.wfh.org/2/9/9_1_statements-2007.htm
Canadian Hemophilia Society Position-Donor Deferral Criteria
https://hemophiliafed.org/uploads/2010/04/Canadian-Hemophilia-Society-MSM-Paper-2-12-2008-2.pdf
Committee of Ten Thousand: Press Release  
https://hemophiliafed.org/uploads/2010/03/COTT-Press-Release-on-MSM.doc
National Hemophilia Foundation: Statement on Blood Donor Deferrals
http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=303&contentid=1486
World Tribune: Senators challenge FDA ban on homosexual men donating blood
http://www.worldtribune.com/worldtribune/WTARC/2010/ss_politics0208_03_16.asp
Los Angeles Times: Featuring community member and advocate Kathy Gerus-Darbison
http://www.latimes.com/news/nationworld/nation/la-na-gays-blood4-2010apr04,0,1335042.story
Wall Street Journal:
http://online.wsj.com/article/SB10001424052702303450704575160081295988608.html
Hemophilia Federation: Voices Blood Safety Concern (American Red Cross) December 2009
https://hemophiliafed.org/2009/12/11/press-release-hfa-voices-blood-safety-concerns/
In our efforts to actively monitor blood safety via attendance and participation at federal agencies, the following is a list of upcoming federal meetings.

•  May 13, 2010: FDA – Quantitative Risk Assessment: Blood Safety and Availability Workshop
• June 10/11, 2010: Tentative.  Advisory Committee on Blood Safety and Availability (ACBSA)
• July 26/27, 2010: BPAC – Blood Products Advisory Committee

HFA’s current position: We support the current FDA policy regarding MSM deferrals based on science and safety. We do not believe there is sufficient scientific evidence to suggest changing this policy. HFA urges decision makers, in the absence of proof, to use the precautionary principle as a guide in protecting the public from exposure to harm. 
Action Plan: HFA will continue to monitor, present our position, and take action when necessary.   We are also active participants in the Plasma User’s Coalition (PUC), a group  of national  organizations who are end users of plasma products.  Some of the activities occurring within the PUC include:

•  Outreach to gay men’s organizations such as the Gay Men’s Health Crisis
• Outreach to the blood collection organizations to hear their perspective
• Collaborate with other community organizations who are end users of blood products to explore working together on this issue   
• Meet and advocate our position and concerns with the US Senators who have asked the FDA to re-examine the current restrictions
• Coordinate a plan of action to present a united position at the upcoming ACBSA meeting

If you have any questions or concerns, please contact HFA’s Public Policy Team at k.carter@hemophiliafed.org.