Presentation Transcript
PPTA – FDA West Nile Virus Working Meeting: PPTA – FDA West Nile Virus Working Meeting April 29, 2003
Agenda: Agenda Introduction and Overview
Risk Assessment – 0.5 hrs
Presentation of worst case WNV challenge to plasma therapies.
Verification Studies – 1.5 hrs
Presentation of individual company research on WNV inactivation/clearance studies (Aventis, Baxter, Bayer)
Donor Screening and Surveillance – 0.5 hrs
Presentation on challenges of donor screening for WNV and discussion of opportunities to conduct surveillance.
Discussion/Next Steps – 0.5 hrs
Discussion of open questions/issues and upcoming BPAC agenda.
Close of Meeting
Point to Consider: Policy Questions:
What is the threshold of risk for testing for this and future agents?
How will the blood system deal with the economics of screening for this and future agents?
(J. Goodman, 6th Annual FDA and Changing the Paradigm for Blood Regulation, New Orleans, LA 2003) Point to Consider
Slide4: Rationale:
Risk and science-based approaches dictate measured responses to minimal risks.
WNV testing would require more refined technological advances than in place for HIV and HCV.
No proportionate public health benefit for WNV testing.
WNV testing adds no meaningful margin of safety for plasma derivatives.
Offers an opportunity to “get ahead of the curve; anticipating new threats” New Paradigm
New Paradigm: New Paradigm Three Part Approach for Addressing WNV:
Risk Assessment
Assessment of relevant epidemiologic factors and worst case challenge to plasma therapies.
Verification Studies
Studies demonstrating efficacy of virus reduction with relevant model or target viruses.
Donor Screening and Surveillance (DSS)
Continued surveillance of WNV epidemic and sentinel parameters for evaluating industry actions.
Uses “blood screening as public health sentinel system for natural . . . disease.”
Surveillance: Surveillance Focus Areas:
Prevalence:
Monitored and reported by CDC
Significant changes may require reevaluating risk assessment worst case assumptions
Viremic Titers:
Coordination with other industry sectors will allow monitoring via sampling plan
Significant changes in anticipated titers may require reevaluating risk assessment and inactivation/removal capacity.
Conclusions: Conclusions The Model virus concept has proven to be predictive!
Three part approach is comprehensive and appropriate for WNV.
Surveillance will provide a safety net in case underlying circumstances change.
No public demand exists for WNV donor screening for plasma derivatives.