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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 September 18, 2006 Mark Weinstein, PhD FDA/CBER/OBRR. Issue.
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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 September 18, 2006 Mark Weinstein, PhD FDA/CBER/OBRR
Issue • There is a possible, but unproven, 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. • The FXI was made using plasma from donors in the United Kingdom (UK), where the human disease variant CJD (vCJD) has occurred.
Issue • 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.
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 SGE’s, including members of the hemophilia community, to obtain advice on risk assessment, interpretation, and communication (message points).
Background • FXI manufactured in the UK from UK plasma was administered to about 50 patients (subjects) in the US under several INDs, from 1989-2000 • Most cases of vCJD have occurred in the United Kingdom (UK). Individuals in the UK are at a higher risk for the disease than individuals elsewhere because of their greater potential for food chain exposure.
Background • In the UK, public health authorities have notified recipients of plasma-derived coagulation products, which in that country had generally been made from UK donor plasma, that they may have an increased risk of vCJD in addition to the risk from eating contaminated beef products. • The CBER risk assessment model indicates that the most important factors affecting risk are the clearance of the vCJD agent though manufacturing steps, how much product individuals used, and the vCJD prevalence in the UK donor population.
CBER Risk Communication Plan • CBER has completed the risk assessment. After obtaining input from SGE’s, FDA will present the following: • The 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” • An interpretive summary of the risk assessment, including uncertainties • Advice to patients
CBER Risk Communication Plan • Teleconference with IND holders to obtain comments and answer questions about the risk assessment • Suggest that IND holders contact and advise patients (subjects) • Internet posting and notification of hemophilia organizations of risk information • Follow-up telecon among FDA and IND holders to assess message impact, number of patients (subjects) contacted, and need for additional information or assistance from FDA and/or CDC.
