Patients Say FDA Lets Big Pharma Create Artificial Drug Shortages
Patients Say FDA Lets Big Pharma Create Artificial Drug Shortages
WASHINGTON (CN) - Two dozen people suffering from life-threatening Fabry disease say the U.S. Food and Drug Administration and the Department of Health and Human Services give drug manufacturers carte blanche to create drug shortages that deny them the medicine that keeps them alive.
Twenty-five people, 13 of them John or Jane Does, sued the agencies in Federal Court on constitutional claims. They also sued the National Institutes of Health, the Mount Sinai School of Medicine, and top officials in the federal agencies.
Most of the plaintiffs say they are being denied interstate access to Fabrazyme, a drug that treats Fabry disease, due to a shortage created by Genzyme, the drug's manufacturer, but not a party to the case.
Lead plaintiff Joseph Carik, who has a doctor's prescription for Fabrazyme, claims: "By and through FDA consent, plaintiff has been banned interstate access to FDA-approved doses of Fabrazyme during a drug shortage created by Genzyme (a Sanofi company) an FDA licensee. Plaintiff is instead forcibly injected with a diluted, unregulated, unapproved dose of Fabrazyme because if the plaintiff refuses infusion of the unapproved dose, then the FDA licensee will withdraw any access and not provide future access to the drug until the shortage is over. The United States defendants have delegated all medical decisions during the shortage regarding plaintiff's disease, life, and health to the sole discretion and control of a corporation regulated by and through grant of an FDA license."
Another plaintiff claims he is being punished because he "switched from the diluted, unregulated, unapproved does of Fabrazyme to an alternative treatment being studied for FDA approval (i.e., Replagal) manufactured by the licensee's competitor. As punishment, plaintiff is banned from future interstate access to FDA-approve doses of Fabrazyme until the FDA licensee, Genzyme (a Sanofi company) declares that shortage is over."
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