July 2012 - FDA has recently announced its intention to modify its previously issued guidance on preventative measures to reduce the risk of possible CJD/vCJD transmission via the use of blood products . As a result of this move, FDA is indicating that it will require manufacturers of drug products made using human serum albumin, which is sourced from donated plasma, to include a warning on the label regarding the risk of transmission of viral diseases and CJD.
The pharmaceutical industry has been moving away from using animal- and human-sourced materials for many years and regulators have issued guidance on the risk posed by blood- and plasma-derived products to patients for some time. Both FDA and EMA have specific requirements for stringent donor screening and viral testing for these products. With this latest guidance, the FDA is raising the issue directly to patients taking drugs made using serum albumin by requiring manufacturers of such drugs to include a warning statement on their labels and package inserts describing the risk associated with the use of this material in respect of viral disease (such as hepatitis A or C) or CJD transmission.
Being entirely animal-free and thus eliminating any possibility of human- or animal-derived virus or prion transmission, the use of a recombinant albumin, such as Novozymes Recombumin® and Albucult®, USP-NF* compliant rAlbumin, would negate the need for this warning.
*Meets National Formulary (NF) standards as published by United States Pharmacopeia (USP).