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Jun 11

FDA Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease

On June 11, 2012, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled Draft Guidance for Industry: Amendment to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products.’ Found here, the Document highlights the recommended changes to labeling in light of current scientific knowledge. Creutzfeldt-Jakob Disease (“CJD”) is a debilitating brain disorder that results in rapidly declining neurological functioning and ultimately death. Related to bovine spongiform encephalitis (“BSE” or “Mad Cow Disease”), variant Creutzfeldt-Jakob Disease (“vCJD”) is extremely rare and thought to have affected fewer than 200 people worldwide. More information about CJD and vCJD may be found here.

As discussed in the Draft Guidance, although plasma derivatives, including albumin (a protein derived from human blood plasma) and products containing plasma-derived albumin, have not been implicated in the transmission of vCJD in the United States, the FDA is recommending the labeling changes after the discovery of such a case involving a woman in the United Kingdom. Despite finding the threat of transmission to be extremely low, particularly with products containing plasma-derived albumin, where the FDA notes that there is “no epidemiological evidence” to support the transmission of CJD or vCJD, the Agency ultimately decided upon these additional warnings to reflect the low-level risk associated with these products. The revised warning statements are as follows:

Plasma-derived products Other than Albumin

Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Plasma-derived Albumin

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin.

Products Containing Plasma-derived Albumin

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

Staying informed of current policies regarding the labeling of FDA-regulated products is important. FDA guidance documents are illustrative of the FDA’s current thinking on the particular topics they address, and while guidance documents technically do not carry the force of law, industry is largely expected to voluntarily comply with the recommendations set forth therein. For more information about FDA guidance documents or assistance with compliance, contact us at contact@giannamore-law.com.

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