(CN) – A federal judge called the Food and Drug Administration’s decision to accept shipments of an unapproved foreign drug for lethal injections “utterly disappointing,” siding with a group of prison inmates who claimed the drug should not be used on death row.
Judge Richard Leon in Washington said the FDA had ignored the risks of foreign-manufactured sodium thiopental, which is used by the Department of Corrections in some southern states to anesthetize death row inmates before lethal injection.
Administering general anesthetic is the first of three steps in lethal injection. When the inmate is unconscious, corrections officers administer pancuronium bromide, which causes paralysis. Then they inject the inmate with potassium chloride, which causes cardiac arrest and death, the ruling states.
The general anesthetic sodium thiopental, a barbiturate, was manufactured in the U.S. until the early 1980s, when the rise of the drug propofol cut out its market share. The FDA approved the use of propofol in 1989, but it never reviewed or approved thiopental for safety and effectiveness.
In 2009, the last U.S. manufacturer of thiopental stopped making the drug.
Since then, Departments of Correction in Georgia, Arkansas, Arizona, Tennessee, and South Carolina have bought seven shipments of the drug from an Austrian manufacturer.
Judge Leon found that the inmates had standing to pursue their claims for risk of harm and the possibility of threatened injury.
He wrote that without FDA approval there was a chance thiopental would fail to render inmates unconscious, causing “conscious suffocation, pain, and cardiac arrest.”
He noted that “few in our society are more vulnerable than a death row inmate facing lethal injection.”
The FDA violated the Administrative Procedure Act and provisions of the Federal Food, Drug and Cosmetic Act (FDCA), the judge stated, because the agency had “a mandatory obligation” to block importation of thiopental, since it was unapproved.
“Here, the FDA has acted inconsistently with FDA regulations, acted inconsistently with its longstanding practices, and acted in a manner contrary to the purpose of the FDCA, thereby threatening the public health,” Leon wrote.
The judge said the FDA’s decision made “little sense in light of the fact that alternative barbiturates for use in lethal injection protocols exist” and accused the agency of “stubbornly clinging to every last ounce of its discretionary authority …”
“By opening up the ‘closed’ drug system by allowing an unapproved drug – thiopental – into the United States, defendants jeopardize their own system and threaten the public health by creating a risk that thiopental could incorrectly end up in the hands of the general public,” Leon wrote.
“Even when in the correct hands, prisoners on death row have an unnecessary risk that they will not be anesthetized properly prior to execution. Further, defendants’ actions also create a slippery slope that other unapproved foreign drugs may be allowed to enter into the United States to the detriment of the general public.”
The FDA initially held the first foreign shipment of thiopental on the grounds that Dream Pharma, the London-based wholesaler that sent the Austrian drug to the U.S., was not registered with the FDA and that the drug was misbranded. But two months later, the FDA caved to the Arkansas Department of Correction’s claim that the drug was “necessary for use in lethal injections.”
In a January 2011 statement defending its importation of the drug, the FDA cited its policy of deferring to law enforcement to support dismissal of the claims.
Judge Leon was not persuaded.
“In the final analysis, the FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner’s needle. How utterly disappointing!” the judge wrote.
Neither the plaintiffs’ law firm nor the FDA immediately responded to requests for comment.