Genzyme's drug shortages are going to court. Some Fabry disease patients are suing Genzyme, which makes Fabrazyme, the only FDA-approved treatment. That drug has been running scarce since contamination at Genzyme's Boston-area plant prompted a shutdown for cleaning and revamping back in 2009.
Seeking class-action status, the plaintiffs claim Genzyme and Mount Sinai School of Medicine, which holds a patent on Fabrazyme, have mishandled the prolonged shortage. The plaintiffs allege that Genzyme's rationing system on Fabrazyme--designed to allow Fabry patients access to the drug, even if not at full doses--has caused as many as three deaths. European regulators studied the lower doses and found they do tend to cause serious problems, including kidney disease, heart attacks and neuropathy.
This isn't the first time several of the same patients have made official bids to get more Fabrazyme. As Pharmalot points out, some of them petitioned the FDA, asking the agency to force Genzyme to allocate the drug to U.S. patients first, rather than set aside some portion of it for sale in overseas markets. Meanwhile, Genzyme has been working to boost capacity for making Fabrazyme; its latest update claimed the supply was improving. Under its merger agreement with Sanofi-Aventis, Genzyme shareholders get an extra payment if supply goals are met.