When a shortage of BCG vaccine used to treat tuberculosis and bladder cancer developed two years ago because of serious problems at a Sanofi ($SNY) Pasteur plant, the FDA asked Merck ($MRK) to pick up the slack. But Merck has had manufacturing issues that interrupted production that it is only now resolving.
Merck said in an email that a "potential manufacturing issue" that arose in August 2014 has been addressed and that it has started to resupply Tice BCG. "In 2012, when Merck became the only source of this medicine in many countries, demand increased substantially. Merck has increased supply of Tice BCG by more than 100% over the past two years to meet this demand." But given back orders, it said supplies will be limited through the rest of the year.
Sanofi Pasteur said in an email that the company is still working on "updates to the production facility for ImmuCyst to ensure the continued supply of this product to Canada and other global markets. At present, Sanofi Pasteur is forecasting a return to the Canadian market for ImmuCyst in the second half of 2015."
According to a blog post on ChicagoNow Wednesday by bladder cancer patient and blogger Kerri Morris, the shortages have been "alarming" to patients with the cancer. That is because the alternative to treatment with BCG can mean a partial removal of the bladder or a radical cystectomy in which the bladder and most of the sexual organs are removed.
The shortages began with Sanofi's bladder cancer drug ImmuCyst in June 2012. Sanofi Pasteur recalled four batches of BCG and suspended production at the plant in Canada after Australian regulators found problems with sterility. An inspection by the FDA of the Canada plant several months before found the drugmaker had been battling mold in the plant after it flooded. The FDA laid out 24 observations, saying the "there have been no less than 58 documented non-conformances relating to the isolation of mold within the BCG aseptic processing areas" since August 2010.
Sanofi said at the time it was working to return the plant to cGMP standards but a recent listing of shortages by the FDA showed Sanofi's vaccine remained unavailable as it works to meet FDA requirements. Merck's notice on the same page said that a shortage of an active pharmaceutical ingredient tied to increased demand had led to the shortage its was experiencing.