Update on Implementation of Revised Guidance on Blood Donor Deferrals for Risk of CJD and vCJD

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Update on Implementation of Revised Guidance on
Blood Donor Deferrals for Risk of CJD and vCJD

• Dorothy Scott, M.D.
• Division of Hematology, Office of Blood
  Evaluation and Research
• CBER/FDA
• June 27, 2002

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Geographic Donor Deferrals and Blood/Plasma Supply

• Precedent largest prior deferral approximately
  5
• Recommended deferrals estimated effects
• Remove 90 of risk (donor-days exposure to BSE)
• Result in average 5 donor loss (REDS study)
• Most affected geographic areas
• New York Blood Center up to 35 donor loss
• Coastal cities up to 10 donor loss

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Chronology

• TSEAC recommends new vCJD geographic donor
  deferrals 6/29/01
• FDA incorporates TSEAC recommendations into draft
  guidance published 8/27/01
• FDA issues final guidance after comment period
  1/09/02
• Implementation FDA-recommended deferrals 5/31/02
  (Phase I), and 10/31/02 (Phase II)

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Efforts to Attenuate Supply Impact of New Donor
Deferrals

• Phased- in deferrals for Blood and Blood
  Components other than Source Plasma
• Exception from pan-European geographic donor
  deferral for donors of Source Plasma for plasma
  derivatives
• Pilot programs recommended for deferrals more
  stringent than FDA-recommended
• TSEAC additional proposal for national
  recruitment campaign, and system to monitor
  adequacy of blood supply

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FDA Final Guidance Donor Deferrals Phase I
Implementation 5/31/01

• U.K. gt 3 months, 1980- 1996
• 2. France gt 5 years, 1980- present
• 3. U.S. military bases, gt 6 months 1980- 1990 N.
  of Alps 1980- 1996 S. of Alps
• 4. Recipients of transfusion in U.K.

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FDA Draft Guidance Donor Deferrals Phase
IIImplementation 10/31/02
Deferral Blood donors who have lived in Europe gt
5 years 1980 - present Donors of Source Plasma
for plasma derivatives remain eligible
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Donor Deferrals
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Blood Supply Updates

• Department of Health and Human Services
• Steve Nightingale, M.D., Executive Secretary
  Advisory Committee Blood Safety and Availability
• New York Blood Center
• R. Jones, M.D., President
• American Red Cross
• P. Page, M.D., Senior Medical Officer
• Americas Blood Centers
• C. Bianco, M.D., Senior Vice President
• Department of Defense
• R. Alford, Major, USAF, BSC
• American Association of Blood Banks
• K. Gregory, Director, Regulatory Affairs