FDA Blood Products Advisory Committee to Meet May 15-16

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MAY-15/16-12  The U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) will meet on May 15th and 16th on a variety of topics including OraSure's application for approval of its OTC rapid HIV test and the evaluation of possible frozen plasma products.

MAY 15TH
The U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) will consider OraSure's application for the approval of its OraQuick® Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter (OTC) market.   The BPAC Committee will review the evaluation of its safety and effectiveness as an OTC rapid test based on findings from the final phase of clinical testing.  Approximately 5,800 subjects were enrolled and tested across 20 sites nationwide, resulting in the identification of more than 100 previously undiagnosed individuals with HIV.  For webcast information, see the "Public Participation" section below.

MAY 16TH
The committee will discuss the evaluation of possible new plasma products frozen following in-process storage at room temperature for up to 24 hours, namely plasma for transfusion prepared from Whole Blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing.  In the afternoon, the committee will hear updates on the following topics: HHS activities related to the evaluation of the donor deferral policy for men who have sex with men (MSM); a summary of the November 8-9, 2011 public workshop on hemoglobin standards and maintaining an adequate blood supply; and a summary of the November 29, 2011 public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products.  For webcast information, see the "Public Participation" section below.

PUBLIC PARTICIPATION
Public participation is welcome for meetings on both days.   Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions must be submitted on or before May 8, 2012.  Click here for additional information about public participation.   The May 15th and 16th meetings will also be webcast for those who are unable to attend.  Click here for additional webcast information.