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."
Another plaintiff says she can't get Aquasol A, a drug she needs to treat her vitamin A deficiency, because of "a drug shortage created by FDA licensee, Hospira Corporation."
The complaint states: "At present there exist over 260 concurrent prescription drug shortages in the U.S., far more than any in history.
"Indeed, for every drug shortage that the FDA has averted, two new ones arise.
"The danger of drug shortages to the health and life of American citizens are well known.
"Once a medically necessary drug is placed into interstate commerce, withdrawal of drug from the market results in grievous harm to patients, just as assuredly as withdrawal of oxygen, food, or water for those who have come to rely on such access for survival."
The problem, the plaintiffs say, is that the FDA lets its drug licensees, such as Genzyme and Hospira, decide whether a patient will be treated during a drug shortage. The corporations also may dilute the medication without FDA approval.
"Indeed, FDA licensees causing drug shortages now exercise absolute control over the physical bodies of American citizens who have come to rely on interstate access to a drug needed to treat their diseases," the complaint states. "Necessarily then, the root cause of every injury from interstate drug shortage (not due to increased demand) is the FDA allowing manufacturers to provide drugs to interstate commerce without backup or safety measures."
The plaintiffs claim: "It would be a simple legal matter for the FDA to intervene during a drug shortage and escrow what little drug is available for interstate distribution with the needs of the people until the licensee returns fully to the interstate market, because the FDA, not FDA licensees, controls the interstate prescription drug market.
"However, the FDA has argued that the FDCA [Food, Drug and Cosmetics Act] is inadequate to protect against shortages because Congress has delegated complete control of public health during a drug shortage to the company causing the drug shortage.
"The FDA reasons that the agency cannot force a company to manufacture a drug under the FDCA.
"While the FDA's statement is true, the FDA fails to acknowledge that the agency's most powerful enforcement measure has nothing to do with forcing a company to make a drug; the FDA has the power to exclude manufacturers from re-entering the interstate market once U.S. patients have been injured or died due to drug shortages attributable in whole or in part to the actions of FDA licensees."
The defendant Mount Sinai School of Medicine holds the patent to Fabrazyme.
The plaintiffs claim, "The conduct by the United States defendants offends core constitutional protections to be free [of] government-deprivation of a serious nature affecting the life, limb, and liberty of individual citizens."
They seek an injunction ordering the government to take the enforcement actions suggested above, they want the drug companies to disgorge profits unjustly created by drug shortages and fined for creating shortages, and they want the patent for Fabrazyme voided.
They are represented by Thomas Dunlap with Dunlap Grubb.