BCAN’s Letter to the FDA – BCG Shortage

May 30, 2012

Dear Dr. Goodman,

At the suggestion of Dr. Andrew von Eschenbach, I am writing to alert you to an alarming drug shortage that is having an extremely harmful impact on tens of thousands of bladder cancer patients in the United States.

Bacille Calmette-Guerin or BCG, is an intravesical immunotherapy drug typically used to prevent recurrences in bladder cancer patients who have high grade tumors or who have CIS or T1 disease.  We have learned from several practicing physicians, as well as affected patients, that pharmacies can no longer obtain BCG, or have a supply that will run out in the next 30 days.  The American Society of Health-System Pharmacists has issued a drug shortage bulletin concerning “BCG Vaccine Live Intravesical” which indicates that there is a shortage of BCG from two manufacturers, Sanofi Pasteur and Merck.   In addition, BCG is included on the FDA’s list of Current Biological Product Shortages.  According to the FDA, Theracys-BCG, manufactured by Sanofi Pasteur, is currently unavailable “due to a manufacturing issue.”  TICE BCG, manufactured by Merck, is available but in short supply because of higher than usual demand due to the unavailability of Theracys-BCG, and may soon “go on allocation if demand exceeds increased production plans and available inventory”.  We have contacted the manufacturers, but no information was available about when the shortage may be resolved.

There is no approved alternative therapy to BCG, so this drug shortage will have a devastating impact on bladder cancer patients.  Approximately 15-20% of the almost 74,000 patients with newly diagnosed bladder cancer will have high risk non-muscle invading cancers and almost all would currently be treated with BCG  (12,000 – 15,000 new cases per year).  If one adds the large pool of patients with prior bladder cancers who experience grade progression upon recurrence and should receive BCG, it is likely that a similar number of these patients should also get BCG.  Thus, conservatively speaking, 24,000 – 30,000 patients in this country will be deprived of the only therapy that can prevent stage progression to muscle invasion, with its obviously adverse consequences in terms of disease outcome and treatment.

BCAN, the Bladder Cancer Advocacy Network, is a non-profit organization dedicated to raising awareness of bladder cancer, advancing research into this disease, and providing resources and support to the bladder cancer community.  On behalf of the tens of thousands of bladder cancer patients and their families, whose lives may be compromised by this BCG shortage, we urge the FDA to find alternative and acceptable sources of BCG as quickly as possible.

We would be happy to meet with you and your staff to discuss how we can work together to protect the lives of bladder cancer patients across the United States.  Please contact me to arrange a meeting at your earliest convenience.

We greatly appreciate your prompt attention to this serious matter.

Respectfully,

Diane Zipursky Quale

President and Co-Founder

Bladder Cancer Advocacy Network

www.bcan.org