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TSEAC December 15, 2006 Mark Weinstein, PhD FDA/CBER/OBRR

Update: Status of FDA’s Initiative on Communication of the Potential Exposure to vCJD Risk from an Investigational Product, Plasma Derived Factor XI that was Manufactured from UK Donor Plasma. TSEAC December 15, 2006 Mark Weinstein, PhD FDA/CBER/OBRR. Issue.

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TSEAC December 15, 2006 Mark Weinstein, PhD FDA/CBER/OBRR

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  1. Update: Status of FDA’s Initiative on Communication of the Potential Exposure to vCJD Risk from an Investigational Product, Plasma Derived Factor XI that was Manufactured from UK Donor Plasma TSEAC December 15, 2006 Mark Weinstein, PhD FDA/CBER/OBRR

  2. Issue • In recent years, questions have been raised concerning the risk from variant Creutzfeldt-Jakob disease (vCJD) in patients who received clotting factor products made from plasma obtained in the United Kingdom (UK), where most cases of this disease have occurred. Since 2003, three people, all in the UK, have probably acquired the vCJD agent through blood cell transfusions. This has increased concern for the potential of vCJD transmission by blood products. • There is a possible health risk to approximately 50 individuals who, between 1989 and 2000, received an investigational (non-U.S. licensed) product, Factor Eleven (FXI), to prevent or treat bleeding due to a rare problem, a deficiency of FXI.

  3. Issue • The FXI was made using plasma from donors in the UK, where the human disease vCJD has occurred. • The FXI product was not made from the plasma of anyone known to have developed the disease and no one who received this product is known to have become infected. • Although the product used was not made from plasma of anyone known to have developed vCJD, it is still possible that a person using the FXI product could have been exposed to the agent that causes vCJD if someone who felt well was carrying the infection at the time of blood donation.

  4. CBER Response • FDA used a computer model to conduct a risk assessment. • FDA reported the preliminary risk assessment results in a TSEAC open session in February 2005. Following input from the TSEAC in February and October 2005, FDA revised its risk assessment. • TSEAC advised FDA to consult with SGEs, including patient advocates, to obtain advice on risk assessment and communication materials (message points).

  5. CBER Risk Communication Plan • CBER completed a draft risk assessment “Potential Exposure to the variant Creutzfeldt-Jakob Disease Agent in United States Recipients of Factor XI Coagulation Product Manufactured in the United Kingdom” http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4088b1.htm (posted in 2005) • CBER has revised the risk assessment and is finalizing communication materials with input from patient advocates and communication experts.

  6. CBER Risk Communication Plan • CBER plans to have teleconferences with IND holders to share information with them, answer questions, and suggest they contact patients (subjects) • Internet posting of finalized materials, notification of Hemophilia Treatment Centers, and patient advocacy organizations

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