More than two dozen people who suffered medication shortages have filed a lawsuit against the US Department of Health and Human Services, the FDA and the National Institutes of Health, arguing their rights were violated because the federal government failed to take adequate enforcement actions against such drugmakers and allow for alternative means to protect supplies.
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.
5 Comments
May I observe that it has been said that "the law is an ass." Now why would that come to mind having read the above?
All of these shortages were due to unforseen manufacturing problems. With respect to the companies, they will be legally protected under the long standing Doctrine of Force Majeure. This is literally defined as "greater force" and excuses a party or parties from liability if some unforseen event beyond the control of the parties prevents them from performing their contractual obligations under the contract. Typically, force majeure clauses cover natural disasters or other "Acts of God", war, or the failure of third parties--such as suppliers and subcontractors--to perform their obligations to the contracting party.
The government has no constitutional responsibility to protect the nation's drug supply, since the US Constition was wriiten more than a century before the first drug company ever existed. Furthermore, if the government tried to regulate it in any way it would be in violation of the commerce clause of the US Constitution for interfering with the execution of interstate commerce.
For all of the above reasons this lawsuit is laughable on its face and should never see the inside of a courtroom.
I see this as an issue of price manipulation using manufactured drug shortages as the means....a fixture in the current version of *capitalism* (power outages, gasoline supplies, etc.)
I don't think *force majeure* covers another possible cause, the lack of properly trained people to do the work.
I think if you read the 90 pages of the lawsuit, you might be as disgusted as I am! But the only difference is, this isn't happening to you! It's happening to me. I am one of the Fabry patients being affected by this drug shortage, and until you walk in my shoes and all Fabry patients shoes, you should read the WHOLE complaint. I think it's hard to make an informed decision or comment as this one until you know the whole entire story! My hands burn constantly, I am so fatigued I can hardly get out of bed sometimes, I have tumors in my kidneys, and am at the first stage of kidney failure! My disease started progressing just after 6 months on an unapproved dose of Fabryzyme. But I am told if I refuse it, I have to go back on a waiting list, and since it is the ONLY drug at this time available, I am a slave to what the drug company gives us, at a dose that has NEVER been approved by the FDA. And they send a product insert in every letter stating what the FDA approved dose is, but they don't give us that. Also, during my first infusion I had a reaction and my throat starting closing, and could of died. I am risk for this same reaction everytime I get treatment. Esp when it's given to us, then taken away for months at a time again. Read the suit before you make such comments, and be thankful this is happening to you or any of your loved ones!
Thank you for your story Fabry. If there are any chenges to cGMP's for these types of drugs it will be that in the future FDA will require companies like Genzyme to certify one backup manufacturing facility for drugs like Fabrazyme. Now that Sanofi is running the show they can afford it. Would probably cost in the neighborhood of $100 million to be fully functional, but with state of the art technology you no longer need dedicated bioreactors, and the cost can be recaptured in a few years.