FDAnews Drug Daily Bulletin

Genzyme Faces Suit Over ‘Arbitrary’ Dose Reduction of Shorted Fabry Drug

April 23, 2012
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The widow of an Idaho Fabry disease patient who died during a shortage of Genzyme’s Fabrazyme is suing the drugmaker, claiming it arbitrarily rationed the drug in favor of young patients and failed to adequately warn about the dangers of taking the drug at reduced doses. The suit makes five claims for relief, the foremost alleging negligence for selling the drug “contaminated with glass, rubber and steel particles,” restricting its administration below the FDA-approved dose and for not stockpiling Fabrazyme (agalsidase beta) to mitigate supply chain disruptions.
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