BCG Shortage Information

BCAN has been monitoring the drug shortage of Bacille Calmette-Guerin or BCG, an intravesical immunotherapy drug typically used to prevent recurrences in patients who have high grade tumors or who have CIS or T1 disease.  The shortage arose when Sanofi, one of the two licensed US suppliers of BCG, ceased production of the product because of manufacturing issues.  Merck, the other supplier of BCG in the U.S., has increased its production of BCG to try to meet the demand. On learning of the shortage BCAN immediately wrote to the FDA  urging the agency to take all actions necessary to resolve this dangerous drug shortage as soon as possible –click here to see the full content of the letter. We received a prompt response from the FDA, telling us that the leadership of its Center for Biologics Evaluation and Research (CBER) is actively engaged in addressing this serious problem. BCAN will stay in contact with the FDA and will keep you apprised of any further developments.  In the meantime, the FDA and BCAN want to hear from you if you are told by your physician that you will not be able to receive your BCG treatment because of this drug shortage . Please report your situation to the FDA by emailing CBERshortage@fda.hhs.gov or calling (301) 827-4239, and report to BCAN atinfo@bcan.org.

FDA links about the BCG shortage:

• · Important Information About BCG Live (Intravesical): Click Here

• · Notice of Inspectional Observations (FDA Form 483): Click Here

• · Main product page for TheraCys: Click Here