Sanofi is halting the production of the main bladder cancer drug. In response, doctors are pressuring regulatory agencies to take action against this instance of a widespread issue of drug shortages.
Sanofi Pasteur announced last week that it will be shutting down the production of the cancer drug BCG (TheraCys and ImmuCyst) in mid-2017. This drug is the main and most effective treatment to prevent recurrence of bladder cancer.
The company tried to keep a low profile by sending the news via email, and no traces of the announcement can be found on their website. In the email, Sanofi stated that it identified several companies to take over production, but none have decided to commit.
The silenced issue behind this decision has actually been going on for a while: in 2011, the FDA found 58 infractions regarding mold sterility in Sanofi’s Toronto manufacturing lab, where the treatment is produced. To avoid contamination of the drugs, the installation was shut down until Sanofi fixed the issues, finally reopening last year.
The whole thing must have impacted Sanofi’s profit and led the company to the recent decision of ending production indefinitely. While the lab was shut down, Merck failed to step up production and cover the demand, leading to shortages starting in 2012. Now, patients are facing again the struggle of missed doses or inferior alternatives.
The US will face shortages of BCG starting in 2017, while Sanofi expects to continue the supply in Canada, France and the UK until the end of 2018. With a stark “We regret any potential impact this decision may have on the needs of patients and their health providers”, the big pharma has left patients and doctors hanging.
The main issue here is that this is not an isolated case. BCG is only one of the hundreds of drugs facing shortages in the US. In Europe, doctors have reported high rates of negative impact on patient health due to shortages. Doctors and patients are putting pressure into the FDA and the EMA to take action and regulate these health-threatening supply shortages.
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