In an illustration of the way the FDA is now enlisting other manufacturers to pick up the slack in a drug shortage, the agency says it is working with a Merck ($MRK) subsidiary and also looking to foreign manufacturers to find drugs to substitute for Sanofi Pasteur's bladder cancer drug TheraCys.
The drug, also known as BCG, was made at Sanofi's plant in Toronto, which closed some operations in June for upgrades after FDA inspectors found mold in aseptic processing areas. Sanofi says the shutdown pushes availability of TheraCys to late next year.
The FDA has reached out to Organon Teknika, a Merck division, to increase the production of TICE, the other licensed source of BCG. The FDA also says it is talking with unlicensed manufacturers outside the U.S. to see if it can scare up some additional supplies to help meet U.S. demand.
The agency in February enlisted India's Sun Pharmaceutical Industries to provide an alternate supply of Johnson & Johnson's ($JNJ) cancer drug Doxil. A shortage of Doxil was created when J&J's contract supplier Ben Venue Laboratories closed a plant in Ohio because of extensive manufacturing problems. The alternative treatment, Lipodox, is being imported from India in a "temporary, limited arrangement" until J&J can secure its own Doxil supplies. That effort has been successful enough that Johnson & Johnson earlier this month said it would be able to release some Doxil for clinical trials.
The FDA post outlining its efforts to dampen the impact of the Sanofi shortage comes only a few weeks after the agency shot back a letter to the House Committee on Oversight and Government Reform, which in a recent report blamed aggressive plant enforcement actions for the surge in drug shortages in recent years. The House report points out that drugmakers--Hospira ($HSP), Teva Pharmaceutical Industries ($TEVA), Sandoz, the generics division of Novartis ($NVS), and Boehringer Ingelheim's Bedford Laboratories--lost 30% of their capacity when the FDA expected them to upgrade their manufacturing.
The agency acknowledged that those plant remediation efforts led to drug shortages but pointed out that if poor manufacturing practices lead to unsafe drugs, it has a responsibility get drugmakers to fix the problems. It said it balances that need against the potential for a shortage of a lifesaving drug.
- here's the FDA release
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