Consideration of labeling claims for tse agent clearance in plasma derivatives
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Consideration of Labeling Claims for TSE Agent Clearance in Plasma Derivatives. TSE Advisory Committee February 20, 2003 Dorothy Scott, M.D. DH/OBRR/CBER/FDA. Reduction of possible risk of CJD and vCJD in Plasma Derivatives: FDA Recommendations. Donor deferrals: vCJD, vCJD risk

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Consideration of Labeling Claims for TSE Agent Clearance in Plasma Derivatives

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Consideration of Labeling Claims for TSE Agent Clearance in Plasma Derivatives

TSE Advisory Committee

February 20, 2003

Dorothy Scott, M.D.

DH/OBRR/CBER/FDA


Reduction of possible risk of CJD and vCJD in Plasma Derivatives: FDA Recommendations

  • Donor deferrals: vCJD, vCJD risk

    • > 3 months travel/residence U.K. (1980- 1996)

    • > 5 years travel/residence France (1980- present)

    • > 6 months U.S. military bases in Europe (1980-1990 or 1996; location-dependent)

    • Transfusion in the U.K. 1980- present

    • U.K.-sourced bovine insulin 1980- present

  • Donor deferrals: CJD, CJD risk (hGH, dura, FH)

  • Quarantine/retrieval plasma unit from donor with CJD, vCJD

  • Withdrawal plasma derivatives with vCJD donor


Current Recommendation: Donors of Source Plasma are not deferred for travel/residence BSE countries (except France and the U.K.)

  • Model TSE agents partitioned/removed during plasma fractionation in published studies

  • European risk of vCJD (except France, U.K.) low because of smaller BSE epidemic relative to U.K.

  • Effects of European donor deferral on nationwide/worldwide plasma supplies uncertain, but potentially severe


vCJD: Ongoing Concerns

  • TSE transmission by blood in animals

    • Rodents

    • Lemurs

    • Experimental BSE in sheep

    • Natural scrapie in sheep

  • Insufficient epidemiologic information

    • Epidemic size unknown (prevalence incubating donors)

    • Likelihood of transmission by blood products unknown

  • Lymphoid tissue expression abnormal protein

    • Implies but does not prove lymphoid tissue more infectious than for CJD

    • Suggests unusual tissue distribution infectious agent


Risk Reduction Measures for Infectious Agents in Plasma Derivatives

Virus CJD

Donor Deferral

Donor Testing

Clearance by Processing

+ +

+

-

+

Possible


Labeling and Transmissible Agents in Plasma Derivatives

  • Labeling

    • Provides estimate of risk of transmission of infectious agents

    • Discusses measures taken to reduce risks

    • Allows the public to make a more informed decision on risk/benefit

  • Labeling claims typically undergo thorough scientific/regulatory review prior to implementation

  • Labeling claims for pathogen removal in the past have been based upon rigorous and specific scientific evidence


Current FDA Recommendation: Labeling for

Risk of CJD in Plasma Derivatives:

“Because [this product] is made from human blood, it carries a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.”


Questions to the Committee

  • Should FDA consider labeling claims for TSE clearance in plasma derivatives, based upon specific demonstration of TSE removal during manufacturing?*

  • Assumes adequacy of decontamination procedures

  • in product manufacturing


Questions to the Committee

  • If so, please comment on whether such data would support the following draft wording for labeling:

    “Because this product is made from human plasma, it carries a risk of transmitting infectious agents, e.g. viruses, and, theoretically the vCJD agent. It has been demonstrated that [the manufacturer’s] manufacturing process provides substantial clearance of agents similar to those causing CJD and vCJD. Thus the theoretical risk of transmission of CJD or vCJD is extremely remote.”


Speakers

  • Virus Removal from Blood Products: Validation, Label Claims, and Possible Paradigm for Removal of TSE Agents

    • Mahmood Farshid, Ph.D., OBRR/FDA

  • TSE Agent Clearance Issues

    • Dorothy Scott, M.D., OBRR/FDA

  • Risk Analysis for TSE’s in Plasma Derivatives

    • Steve Anderson, Ph.D., OBE/FDA

  • European Perspective on TSE Agent Clearance in Plasma Derivatives

    • Sol Ruiz, Ph.D., Spanish Medicines Agency

  • TSE Clearance Studies by Plasma Manufacturers

    • Henry Baron, M.D., Aventis Behring, speaking for Plasma Protein Therapeutics Association


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