HHS Secretary’s HHS Secretary’s Advisory Committee on Advisory Committee on

Blood Safety and AvailabilityBlood Safety and Availability

Summary for FDA’s BPACSummary for FDA’s BPACJuly 2010July 2010

Jerry A. Holmberg, Ph.D.Jerry A. Holmberg, Ph.D.Senior Advisor Senior Advisor

for for Blood PolicyBlood Policy

ACBSA CharterACBSA CharterThe Advisory Committee on Blood Safety and Availability The Advisory Committee on Blood Safety and Availability provides advice to the Secretary and to the Assistant provides advice to the Secretary and to the Assistant Secretary for Health. The Committee advises on a range of Secretary for Health. The Committee advises on a range of policy issues to include:policy issues to include:

definition of public health parameters around safety and definition of public health parameters around safety and availability of the blood and blood products,availability of the blood and blood products,

broad public health, ethical and legal issues related to broad public health, ethical and legal issues related to transfusion and transplantation safety, andtransfusion and transplantation safety, and

the implications for safety and availability of various economic the implications for safety and availability of various economic

factors affecting product cost and supplyfactors affecting product cost and supply..

ACBSA Topic ACBSA Topic June 10-11, 2010June 10-11, 2010

The HHS Advisory Committee on Blood Safety and The HHS Advisory Committee on Blood Safety and Availability (ACBSA) met to discuss the current policy on Availability (ACBSA) met to discuss the current policy on men who have sex with other men (MSM). men who have sex with other men (MSM).

FDA’s current donor qualification states that MSM at any FDA’s current donor qualification states that MSM at any time since 1977 are currently deferred as blood donors.time since 1977 are currently deferred as blood donors.

BPAC has discussed on several previous sessions.BPAC has discussed on several previous sessions.

FDA Workshop on Behavioral Based Deferral March 2006FDA Workshop on Behavioral Based Deferral March 2006

ACBSA June AgendaACBSA June Agenda Scientific Rationale for the Current PolicyScientific Rationale for the Current Policy Epidemiology of TTD in Individuals Practicing High Risk Epidemiology of TTD in Individuals Practicing High Risk

Behavior compared to the General PopulationBehavior compared to the General Population Risk Assessments in US and other CountriesRisk Assessments in US and other Countries Computerized Inventory Management in Blood Collection Computerized Inventory Management in Blood Collection

EstablishmentsEstablishments Reliability of Donor Questionnaires to address High Risk Reliability of Donor Questionnaires to address High Risk

Sexual BehaviorSexual Behavior Hemovigilance and Data SetsHemovigilance and Data Sets Societal Considerations of MSM Deferral PolicySocietal Considerations of MSM Deferral Policy

ACBSAACBSA The ACBSA engaged in deliberations and discussed the following: The ACBSA engaged in deliberations and discussed the following:

important factors to consider in making a policy change; important factors to consider in making a policy change; scientific information including risk assessments; scientific information including risk assessments; whether any additional studies are needed before implementing whether any additional studies are needed before implementing

a policy change or following a policy change; a policy change or following a policy change; monitoring tools or surveillance activities that could be monitoring tools or surveillance activities that could be

implemented, and whether those should be implemented implemented, and whether those should be implemented before implementing any policy change; and, before implementing any policy change; and,

whether additional safety measures, if any, are needed to whether additional safety measures, if any, are needed to assure blood safety under a revised deferral policy.assure blood safety under a revised deferral policy.

ACBSA RecommendationsACBSA Recommendations Committee Question:Committee Question:

Should the current indefinite deferral for men who have Should the current indefinite deferral for men who have had sex with another man (MSM) even on time since had sex with another man (MSM) even on time since 1977 be changed at the present time? 1977 be changed at the present time?

Committee Vote: 6 Yes: 9 NoCommittee Vote: 6 Yes: 9 No Committee Recommendation: Committee Recommendation: Unanimous supportedUnanimous supported

““The HHS’s ACBSA is sensitive to the blood system and The HHS’s ACBSA is sensitive to the blood system and broader societal issues related to the current deferral broader societal issues related to the current deferral policy for males who have had sex with another man policy for males who have had sex with another man (MSM) even one time since 1977.(MSM) even one time since 1977.

ACBSAACBSA““Whereas we believe that the current donor deferral Whereas we believe that the current donor deferral policies are suboptimal in permitting some potentially high policies are suboptimal in permitting some potentially high risk donations while preventing some potentially low risk risk donations while preventing some potentially low risk donations, we find that currently available scientific data donations, we find that currently available scientific data are inadequate to support change to a specific alternate are inadequate to support change to a specific alternate policy; therefore, until further evaluation, the committee policy; therefore, until further evaluation, the committee recommends that the current indefinite deferral for men recommends that the current indefinite deferral for men who have had sex with another man even one time since who have had sex with another man even one time since 1977 not be changed at the present time. 1977 not be changed at the present time.

ACBSAACBSATo develop and validate candidate alternative policies, we recommend To develop and validate candidate alternative policies, we recommend research in the following areas:research in the following areas:1.1.Validate modifications to the donor questionnaire that would better Validate modifications to the donor questionnaire that would better differentiate low versus high risk MSM and heterosexuals, including differentiate low versus high risk MSM and heterosexuals, including studies to investigate TTID and STD markers in potential donor studies to investigate TTID and STD markers in potential donor subsets;subsets;2.2.Establish ongoing national hemovigilance programs for TTID markers Establish ongoing national hemovigilance programs for TTID markers in blood donors linked to analysis of demographic, behavior, and other in blood donors linked to analysis of demographic, behavior, and other risk factors:risk factors:

a)a) Obtain a baseline on prevalence and incident of TTID’s,Obtain a baseline on prevalence and incident of TTID’s,b)b) Characterize risk in different donor subgroups (e.g., younger Characterize risk in different donor subgroups (e.g., younger

age) , andage) , andc)c) Use above characteristics for continuous quality improvement Use above characteristics for continuous quality improvement

of the donor deferral process;of the donor deferral process;

ACBSAACBSATo develop and validate candidate alternative policies, we recommend To develop and validate candidate alternative policies, we recommend research in the following areas:research in the following areas:3.3.Determine the feasibility of donor pre-testing to limit risk while Determine the feasibility of donor pre-testing to limit risk while characterizing donors who might be recruited under modified eligibility characterizing donors who might be recruited under modified eligibility criteria;criteria;4.4.Investigate the impact of revised donor criteria on the global Investigate the impact of revised donor criteria on the global availability of plasma products;availability of plasma products;5.5.Evaluation of data from other countries that have changed their high Evaluation of data from other countries that have changed their high risk donor evaluation programs, including MSM; and risk donor evaluation programs, including MSM; and 6.6.Periodic reassessment of transfusion safety including consideration Periodic reassessment of transfusion safety including consideration of multiple and cumulative blood product exposures to recipients. of multiple and cumulative blood product exposures to recipients.

ACBSAACBSAAdditionally, the Committee recommends the following actions, Additionally, the Committee recommends the following actions, 1.1.Implement the January 2008 recommendation to adopt pathogen reduction Implement the January 2008 recommendation to adopt pathogen reduction technologies for all transfusible blood componentstechnologies for all transfusible blood components2.2.Create a more robust donor education program focusing on high risk Create a more robust donor education program focusing on high risk behaviors that is more inclusive of all donor groups, emphasizing the link behaviors that is more inclusive of all donor groups, emphasizing the link between safe donations and recipient healthbetween safe donations and recipient health3.3.The Department should take action to investigate and reduce the risk of The Department should take action to investigate and reduce the risk of Quarantine Release Errors (QREs) in blood collection establishmentsQuarantine Release Errors (QREs) in blood collection establishments4.4.Recognizing the relationship between acceptance of risk of transfusion and Recognizing the relationship between acceptance of risk of transfusion and protection from harms, further consideration should be given to mechanisms for protection from harms, further consideration should be given to mechanisms for compensation for blood injuries consistent with the recommendation of the compensation for blood injuries consistent with the recommendation of the Institute of Medicine and the U.S. Congress. Institute of Medicine and the U.S. Congress.

QuestionsQuestionshttp://www.hhs.gov/bloodsafetyhttp://www.hhs.gov/bloodsafety