In their lawsuit, which was filed this morning in federal court in Washington DC, the patients argue that FDA licenses to drugmakers that cause shortages should be invalidated and their patents declared unenforceable. And they want the federal government to escrow drugs and enter into contract manufacturing to maintain availability, much as the HHS already does for pandemic flu vaccines.
"Corporations that cause drug shortages through their own negligence and indifference to human life should be immediately excluded from interstate commerce for breaching the public trust," says their attorney, Allen Black. "Corporations that cause drug shortages have demonstrated beyond a doubt that they cannot provide a reliable drug supply, so there is no rational to reward them with future profits from the remaining survivors of the shortage.”
The lawsuit was filed by patients who have encountered short supplies of two drugs. One is Fabrazyme, a medicine used to treat Fabry disease, a rare, but life-threatening genetic disease that is made by Genzyme (see a shortage report). The other is Aquasol A is an injectable drug made by Hospira used to treat vitamin A deficiency and often taken by Fabry patients. Both drugmakers have experienced numerous and sustained manufacturing problems (read here).
The lawsuit arrives as the US grapples with a worsening shortage of various prescription medications, from life-saving cancer drugs to pills that are taken by children who suffer from attention deficity hyperactivity disorder (read here and here). Shortages exist for hundreds of medicines (see the FDA list) and have spawned Congressional hearings and legislative efforts to bolster FDA authority.
The FDA is prevented from requiring drugmakers to provide info about shortages or take certain actions to prevent or alleviate them. As the US Government Accountability Office noted in a recent report, the only authority the FDA has pertains to reporting discontinued drugs that are life supporting, life sustaining or used to prevent a debilitating disease or condition - when such a drug is made by just one company (back story).
The FDA, meanwhile, has been caught in a conundrum. On one hand, the agency has attempted to get tougher on manufacturing violations in the wake of the Heparin safety scandal. But in doing so, some drugmakers complain that agency scrutiny has contributed to some shortages. Industry watchers, however, say shortages occur when some markets become less profitable or are exacerbated if other drugmakers have little incentive to try to compete.
The genesis of the lawsuit can be traced to the long-running manufacturing gaffes at Genzyme, which ultimately signed a consent decree with the FDA due to its string of problems (read here) and, meanwhile, rationed the amount of Fabrazyme to patients in the US. Some have previously filed a lawsuit against the drugmaker, which is now owned by Sanofi, as well as the NIH and Mt. Sinai, which had been awarded an NIH grant and invented Fabrazyme (back story and licensing agreement).
As part of their effort, the patients have also petitioned the NIH to override use patents held by Genzyme and have been seeking a so-called march-in petition. Their hope has been to secure rights that will attract a partner interested in producing a sufficient supply of the medication in light of ongoing shortages. Last month, both the FDA and the European Medicines Agency approved a new Genzyme plant to produce Fabrazyme, suggesting shortages would be alleviated in coming months (look here).
Nonetheless, the Fabry patients argue their situation was worsened because the federal government failed to take sufficient steps to ensure shortages could be alleviated. Black contends their civil rights were violated because the states require a drug to be available at "historically produced levels" that physicians and patients depend upon. "If there is no notice and a lack of planning then public health is compromised and individual patients cannot make treatment decisions for themselves. The violation is from the drug not being there when its needed and such a need is foreseeable," he tells us.
The lawsuit argues that the the federal government "illegally interfered" with the treatment decisions that were made by state-licensed physicians, since the shortages precluded treatment, and also endangered patient health. Calling this an "intrusion against the practice of medicine," they also argue that the federal agencies violated their Fifth and Tenth Amendment rights, as well as a right to privacy and control their own bodies.
“The FDA should not allow Americans to be held hostage by drug companies creating or threatening shortages," he says. "Americans citizens, through the government, are the ones in control the drug market. The government can make all of the drug that is needed if corporations cannot. It is irrelevant whether a private corporation finds a drug profitable. If Americans need a drug to survive, they have a fundamental Constitutional right to access.”
Among the demand sought by the patients: prevent drugmakers from making allocation decisions based on private health information and require all drug shipments go to a court-appointed third party for allocation; prevent drugmakers from telling investors, doctors or patients about when shortages are expected to end until the FDA has been able to determine whether timelines are accurate; and prevent drugmakers from exporting drugs overseas outside of the jurisdiction of the courts and interstate commerce during a domestic shortage; and give the courts, Congress or the states authority for making rationing decisions.