FDA Workshop

1. “Exercise Only” Emerging Infection Scenario, Morning Session FDA Workshop “Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases for Blood and Blood Products” November 29, 2011, Gaithersburg MD

2. “Exercise Only” Viral Hemorrhagic Fever Outbreak • Viral hemorrhagic fever outbreak newly recognized in three Midwestern states (rural areas only so far) • Flu-like symptoms (fever, headache, chills) • 3% hemorrhagic manifestations (blood tx reqd) • 312 hospitalizations, 48 deaths • Cases mostly < 25 yrs (likely herd immunity) • Schools closed in affected areas Emerging Infection Scenario, Morning Session

3. “Exercise Only” Current Blood Safety Concerns • Asymptomatic viremic cases among donors • 5 cases of transfusion-transmitted fever virus have been reported to CDC in November 2011 • Case investigations show linkage with blood donations from the affected area • Blood supply beginning to show stress in surrounding urban areas • No FDA-approved test for this infection Emerging Infection Scenario, Morning Session

4. “Exercise Only” Current and Pending Actions • FDA issues temporary blood collection ban in affected. The area is also requiring extra blood to treat a growing number of cases • Donors who may be deferred: • have traveled or lived in the affected area • close contacts of cases • disease symptoms Emerging Infection Scenario, Morning Session

5. “Exercise Only” Questions to the Panel • What information is critical to managing this outbreak with respect to transfusion safety and blood supply? • What are the major barriers you see for adding questionnaire screening items? • For example, is new ethical review board approval necessary for you to be able to add questionnaire items? • Which steps would take the most time? • How can the FDA expedite solutions Emerging Infection Scenario, Morning Session