Vaccines, Blood & Biologics
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Important Information about BCG Live (Intravesical)
TheraCys [BCG Live (Intravesical)], manufactured by Sanofi Pasteur, Ltd. is currently unavailable due to manufacturing issues and, according to Sanofi Pasteur, Ltd., is forecast to remain unavailable until late 2013. TheraCys BCG is used for the treatment of non-muscle invasive bladder cancer.
FDA understands the critical need for BCG and is working diligently within our legal authority to help alleviate the shortage of this product.
- FDA has been working with and continues to work with Organon Teknika, Corporation LLC, a subsidiary of Merck & Co, Inc., to increase the production of TICE [BCG Live (Intravesical)] to assist with meeting critical patient needs during this shortage. TICE BCG is the other U.S. licensed source of BCG.
- FDA continues to reach out globally to manufacturers of BCG who are not licensed in the U.S. in an attempt to identify additional alternate suppliers to meet U.S. demand.
- To help minimize the disruption in patient care, FDA encourages physicians, distributors and others not to stockpile the BCG product.
- In the meantime, because of increased demand for TICE BCG, customers may experience shortages as the demand for this product exceeds the available inventory. It is hoped that increased production of TICE BCG will help to minimize the impact of the overall BCG shortage.
- We recommend patients with bladder cancer work closely with their health care professionals. Your doctor is in the best position to assess your medical situation and determine your course of treatment.
Background Information
- During April, 2012, FDA conducted an inspection of the Sanofi Pasteur Ltd. facility located in Toronto, Canada. At the close of the inspection on April 25, 2012, FDA issued a Form FDA 483, List of Inspectional Observations.
- The inspectional observations included numerous deviations relating to the isolation of mold within the aseptic processing areas.
- In addition to these concerns, the investigators noted the failure of the re-validation of the firm’s sterility test method for TheraCys BCG, which called into question the current test method’s ability to detect yeast and mold, if present, in sterility test samples.
- Because of the characteristics of the product, BCG must be produced entirely in an aseptic processing environment which is intended to prevent contamination of the product with other potentially harmful microorganisms.
- On June 21, 2012, Sanofi Pasteur informed FDA of its decision to temporarily suspend manufacturing of TheraCys BCG in order to renovate the facility where the product is manufactured to improve the quality of the environment of the manufacturing facility.
- For additional information on the inspectional observations see the list of Inspectional Observations (Form FDA 483) that was issued at the conclusion of the inspection.
Information about BCG
- BCG is an attenuated live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. Additional information about TheraCys BCG and TICE BCG is available on our website.
- Additional information on this and other biological product shortages can be found on our Biologic Product Shortages page, and in our Q&A.
- If you have additional questions, please feel free to contact FDA’s Center for Biologics Evaluation and Research by phone at (800) 835-4709, or by email at ocod@fda.hhs.gov.
If you have additional questions, please feel free to contact FDA’s Center for Biologics Evaluation and Research by phone at (800) 835-4709, or by email at ocod@fda.hhs.gov.
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