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Topic 1: FDA Draft Guidance “Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products”. Dorothy Scott, M.D. Office of Blood Research and Review FDA October 25, 2001. Previous Guidance- Deferrals . vCJD, CJD

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dorothy scott m d office of blood research and review fda october 25 2001

Topic 1: FDA Draft Guidance “Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products”

Dorothy Scott, M.D.

Office of Blood Research and Review

FDA

October 25, 2001

previous guidance deferrals
Previous Guidance- Deferrals
  • vCJD, CJD
  • Risk factors for classical CJD (Family history, growth hormone injections, dura mater transplant
  • BSE exposure risk: travel/residence in U.K. > 6 months 1980-1996; injection bovine insulin (U.K. source)
post 1999 guidance
Post 1999 Guidance
  • Increasing rate of vCJD epidemic in United Kingdom
  • Increased BSE epidemic detected in Europe (more countries, more cattle)
  • Sheep transfusion transmission BSE (Lancet 366:999-1000, 2000)
  • Continued scientific uncertainty - vCJD transmitted by blood ?
tseac 6 28 2001
TSEAC 6/28/2001
  • Considered increased donor deferral for vCJD risk (BSE exposure)
  • Weighed risk of shortage blood and need for precautionary measures
    • long incubation period limits epidemiological studies although if transmission possible, deferrals have current importance
    • experimental studies on infectivity of vCJD blood limited to date
    • blood shortage possible if large donor deferrals recommended
tseac 6 28 20011
TSEAC 6/28/2001

Opinions and votes by TSEAC incorporated

into FDA draft guidance 8/27/01

(http://www.fda.gov/cber/gdlns/cjdvcjd.htm)

New donor deferrals decrease risk (based upon

exposure to BSE) 91%; 5% donor loss anticipated

(based on REDS survey data)

- Phased implementation

- Pilot studies for more stringent deferrals

- Blood vs. Plasma (European donor deferral)

- Blood supply monitoring

fda draft guidance donor deferrals phase i implementation 5 31 02
FDA Draft Guidance: Donor Deferrals Phase IImplementation 5/31/02

1. U.K. > 3 months, 1980- 1996

2. France > 5 years, 1980- present

3. U.S. military base, > 6 months 1980- 1990

N. of Alps; 1980- 1996 S. of Alps

4. Recipients of transfusion in U.K.

u k donor deferral 1980 1996 food chain controls
U.K. Donor Deferral 1980- 1996Food Chain Controls
  • U.K. implemented measures to prevent entry BSE into human food chain by 1996
    • SRM ban (brain, spinal cord, intestines, etc.)
    • ban on mechanically recovered meat from vertebral columns
    • over-30-months scheme

From “BSE in Great Britain: A Progress Report,” DEFRA June 2001

http://www.defra.gov.uk/animalh/bse/index.html

slide8

Cases of BSE by year of report - U.K. Through

June 30, 2001 - The Declining Epidemic and Effectiveness U.K. Measures

Year BSE cases

(a) 442 (all cases prior to becoming notifiable)

1988 2469

1989 7137

1990 14,181

1991 25,032

1992 36,682

1993 34,370

1994 23,945

1995 14,302

1996 8,016

1997 4,312

1998 3,179

1999 2,274

2000 1354

2001* 311

Total 178,006

From “BSE in Great Britain: A Progress Report,” DEFRA June 2001

http://www.defra.gov.uk/animalh/bse/index.html

non european bse
Non-European BSE

First case documented September 2001in Japan

- Confirmed in U.K.

- USDA import ban announced 9/2001

MBM from U.K. shipped to many non-European

countries, now also at risk for BSE

- Need to assimilate current deferrals

- Future consideration additional deferrals

- Emphasizes importance food chain controls

fda draft guidance donor deferrals phase ii implementation 10 31 02
FDA Draft Guidance: Donor Deferrals Phase IIImplementation 10/31/02

Deferral Blood donors who have lived in Europe

> 5 years 1980 - present

Donors of Source Plasma for plasma derivatives

remain eligible

source plasma
Source Plasma
  • Model TSE agents partitioned/removed during plasma fractionation
  • European risk of vCJD low (small BSE epidemic relative to U.K.)
  • Magnitude of risk reduction achieved by fractionation at a minimum, 2 logs greater than that achievable by donor deferral
  • Effects on nationwide/worldwide plasma supplies uncertain, but potentially severe
source plasma1
Source Plasma
  • Source vs. recovered plasma- differentiated to prevent potential errors in use of deferred non-plasma components
  • Recommendation will be reevaluated in light of additional epidemiologic evidence, transmission studies, and advances in validation of removal TSE agents by manufacturing
effects of new donor deferrals upon supply of blood blood components
Effects of New Donor Deferrals Upon Supply of Blood/blood components
  • FDA- recommended deferrals: 5% of donors deferred (REDS study)
    • greater proportion in coastal cities
    • 35% of NYBC supply affected (Euroblood + U.S. deferrals)
  • Industry-proposed deferrals (3 months U.K.; 6 months Europe): 3% donors deferred (industry study); 9 % donors deferred (REDS study)
slide14

TSEAC Proposal Concerning Implementation of New Donor Deferrals, that “a national recruitment campaign and a system to monitor adequate blood supply,” be instituted

current efforts to attenuate effect of new donor deferrals on blood supply
Current Efforts to Attenuate Effect of New Donor Deferrals on Blood Supply
  • Phased-in deferrals, particularly European deferral (least risk - least BSE exposure)
  • Recommending Pilot studies for more stringent deferrals
    • pilot program - donor recruitment, evaluation donor loss, endpoints for pilot
    • monitor recruitment efforts, fluctuations in hospital demand
current efforts to attenuate effect of new donor deferrals on blood supply1
Current Efforts to Attenuate Effect of New Donor Deferrals on Blood Supply
  • National monitoring of blood supply, demand in place
  • Encouragement of donor recruitment
  • Encouraged cooperation among blood providers to supply in case of regional shortages
draft guidance future
Draft Guidance - Future
  • Collection and evaluation comments to the docket (period extended through October 28, 2001)
  • Issuance of final guidance, with revisions
  • Monitoring of blood supply as recommendations effected
  • Continued assessment blood and plasma risk/benefit of donor deferrals
tseac recommended donor deferrals risk reduction
TSEAC-Recommended Donor Deferrals – Risk Reduction

Current Risk reduced 72 %

(Total Risk Reduced 91%)